{
    "info": {
        "nct_id": "NCT00387920",
        "official_title": "A Phase I Study of Sunitinib (SU11248), an Oral Multi-Targeted Tyrosine Kinase Inhibitor, in Children With Refractory Solid Tumors",
        "inclusion_criteria": "* Histologically confirmed solid tumor (not required for patients with intrinsic brain stem tumors or optic pathway gliomas)\n\n  * Recurrent or refractory disease\n* Measurable or evaluable disease\n* No known curative therapy or therapy proven to prolong survival with an acceptable quality of life exists\n* Patients with metastatic bone marrow disease are eligible but are not evaluable for hematologic toxicity\n\n  * Must not be refractory to red blood cell or platelet transfusions\n* Primary CNS tumors or known CNS metastases allowed\n\n  * Neurological deficits must have been relatively stable for ≥ 1 week before study enrollment\n  * No imaging evidence of prior intracranial hemorrhage\n  * No evidence of new CNS hemorrhage on baseline MRI obtained within 14 days before study enrollment (ECHO gradient MRI sequences per institutional guidelines required for evaluation of CNS hemorrhage)\n\n    * The presence of small punctuate CNS hemorrhage on these scans will exclude a patient from participation\n* No known bone marrow metastatic disease\n* No tumors involving the pleural surface\n* Karnofsky performance status (PS) 50-100% (> 10 years of age) OR Lansky PS 50-100% (≤ 10 years of age)\n* Absolute neutrophil count ≥ 1,000/mm³*\n* Platelet count ≥ 100,000/mm³ (transfusion independent)*\n* Hemoglobin ≥ 8.0 g/dL (transfusions allowed)*\n* Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine based on age/gender as follows:\n\n  * No greater than 0.8 mg/dL (2 to 5 years of age)\n  * No greater than 1 mg/dL (6 to 9 years of age)\n  * No greater than 1.2 mg/dL (10 to 12 years of age)\n  * No greater than 1.5 mg/dL (male) OR 1.4 mg/dL (female) (13 to 15 years of age)\n  * No greater than 1.7 mg/dL (male) OR 1.4 mg/dL (female) (≥ 16 years of age)\n* Bilirubin ≤ 1.5 times upper limit of normal (ULN)\n* ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for liver metastases)\n* Albumin ≥ 2 g/dL\n* LVEF or shortening fraction normal\n* Corrected QT interval ≤ 450 msec\n* Amylase ≤ 1.5 times ULN\n* Lipase ≤ 1.5 times ULN\n* Body surface area ≥ 0.5 m² (≥ 0.4 m² for part B)\n* Blood pressure within ULN\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No uncontrolled infection\n* Able to swallow sunitinib malate capsules (part A only)\n* No pre-existing thyroid abnormality (hyper- or hypothyroidism) with unstable thyroid function\n* No prior CNS hemorrhage\n* No history of allergic reaction attributed to sunitinib malate or component of sunitinib malate capsules\n* No allergy to both applesauce and yogurt (part B only)\n* Recovered from prior therapy\n* No prior sunitinib malate\n* No prior anthracycline (any dose)\n* No prior radiotherapy to a radiation field that included the heart(including total body or craniospinal irradiation)\n* At least 3 months since prior stem cell transplantation or rescue (without total-body irradiation) and no evidence of graft-vs-host disease\n* At least 2 weeks since prior local, palliative, small-port radiotherapy (at least 6 months for radiation to ≥ 50% of pelvis)\n* At least 6 weeks since other prior substantial bone marrow radiotherapy\n* At least 3 weeks since prior myelosuppressive therapy (6 weeks for nitrosoureas)\n* At least 1 week since prior antineoplastic biologic agents\n* At least 1 week since prior and no concurrent hematopoietic growth factors\n* At least 12 days since prior and no concurrent CYP3A4 inducers, including any of the following:\n\n  * Rifampin\n  * Rifabutin\n  * Carbamazepine\n  * Phenobarbital\n  * Phenytoin\n  * Hypericum perforatum (St. John's wort)\n  * Efavirenz\n  * Tipranavir\n* At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:\n\n  * Azole antifungals (e.g., itraconazole or ketoconazole)\n  * Clarithromycin\n  * Erythromycin\n  * Diltiazem\n  * Verapamil\n  * HIV protease inhibitors (e.g., indinavir, saquinavir, ritonavir, atazanavir, or nelfinavir)\n  * Delavirdine\n* No more than 1 concurrent antihypertensive agent\n* No concurrent major surgery\n* No concurrent antithrombotic or antiplatelet agents, including any of the following:\n\n  * Warfarin\n  * Heparin\n  * Low molecular weight heparin\n  * Acetylsalicylic acid (aspirin)\n  * Ibuprofen\n  * Other nonsteroidal anti-inflammatory drugs\n* No concurrent medication for the treatment of hypertension\n* No other concurrent investigational drugs\n* No other concurrent anticancer agents, including chemotherapy, radiotherapy, immunotherapy, or biologic therapy\nHealthy volunteers allowed\nMust have minimum age of 2 Years\nMust have maximum age of 21 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Histologically confirmed solid tumor (not required for patients with intrinsic brain stem tumors or optic pathway gliomas)",
                "criterions": [
                    {
                        "exact_snippets": "Histologically confirmed solid tumor",
                        "criterion": "solid tumor",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    },
                    {
                        "exact_snippets": "intrinsic brain stem tumors",
                        "criterion": "intrinsic brain stem tumors",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "optic pathway gliomas",
                        "criterion": "optic pathway gliomas",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "exact_snippets": "intrinsic brain stem tumors",
                            "criterion": "intrinsic brain stem tumors",
                            "requirement": {
                                "requirement_type": "exclusion",
                                "expected_value": true
                            }
                        },
                        {
                            "exact_snippets": "optic pathway gliomas",
                            "criterion": "optic pathway gliomas",
                            "requirement": {
                                "requirement_type": "exclusion",
                                "expected_value": true
                            }
                        }
                    ]
                },
                "then_criteria": null,
                "else_criteria": {
                    "exact_snippets": "Histologically confirmed solid tumor",
                    "criterion": "solid tumor",
                    "requirement": {
                        "requirement_type": "confirmation",
                        "expected_value": "histologically confirmed"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Recurrent or refractory disease",
                "criterions": [
                    {
                        "exact_snippets": "Recurrent",
                        "criterion": "disease recurrence",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "refractory disease",
                        "criterion": "disease refractoriness",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Recurrent",
                        "criterion": "disease recurrence",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "refractory disease",
                        "criterion": "disease refractoriness",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No known curative therapy or therapy proven to prolong survival with an acceptable quality of life exists",
                "criterions": [
                    {
                        "exact_snippets": "No known curative therapy",
                        "criterion": "curative therapy",
                        "requirement": {
                            "requirement_type": "existence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "therapy proven to prolong survival with an acceptable quality of life exists",
                        "criterion": "therapy proven to prolong survival with an acceptable quality of life",
                        "requirement": {
                            "requirement_type": "existence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No known curative therapy",
                        "criterion": "curative therapy",
                        "requirement": {
                            "requirement_type": "existence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "therapy proven to prolong survival with an acceptable quality of life exists",
                        "criterion": "therapy proven to prolong survival with an acceptable quality of life",
                        "requirement": {
                            "requirement_type": "existence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with metastatic bone marrow disease are eligible but are not evaluable for hematologic toxicity",
                "criterions": [
                    {
                        "exact_snippets": "metastatic bone marrow disease",
                        "criterion": "metastatic bone marrow disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "evaluable for hematologic toxicity",
                        "criterion": "hematologic toxicity evaluation",
                        "requirement": {
                            "requirement_type": "evaluable",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "metastatic bone marrow disease",
                        "criterion": "metastatic bone marrow disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "evaluable for hematologic toxicity",
                        "criterion": "hematologic toxicity evaluation",
                        "requirement": {
                            "requirement_type": "evaluable",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Must not be refractory to red blood cell or platelet transfusions",
                "criterions": [
                    {
                        "exact_snippets": "Must not be refractory to red blood cell ... transfusions",
                        "criterion": "refractory to red blood cell transfusions",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Must not be refractory to ... platelet transfusions",
                        "criterion": "refractory to platelet transfusions",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must not be refractory to red blood cell ... transfusions",
                        "criterion": "refractory to red blood cell transfusions",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Must not be refractory to ... platelet transfusions",
                        "criterion": "refractory to platelet transfusions",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Primary CNS tumors or known CNS metastases allowed",
                "criterions": [
                    {
                        "exact_snippets": "Primary CNS tumors",
                        "criterion": "primary CNS tumors",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "known CNS metastases allowed",
                        "criterion": "CNS metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Primary CNS tumors",
                        "criterion": "primary CNS tumors",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "known CNS metastases allowed",
                        "criterion": "CNS metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Neurological deficits must have been relatively stable for ≥ 1 week before study enrollment",
                "criterions": [
                    {
                        "exact_snippets": "Neurological deficits must have been relatively stable for ≥ 1 week",
                        "criterion": "neurological deficits",
                        "requirement": {
                            "requirement_type": "stability duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Neurological deficits must have been relatively stable for ≥ 1 week",
                        "criterion": "neurological deficits",
                        "requirement": {
                            "requirement_type": "stability duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No imaging evidence of prior intracranial hemorrhage",
                "criterions": [
                    {
                        "exact_snippets": "No imaging evidence of prior intracranial hemorrhage",
                        "criterion": "intracranial hemorrhage",
                        "requirement": {
                            "requirement_type": "imaging evidence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No imaging evidence of prior intracranial hemorrhage",
                        "criterion": "intracranial hemorrhage",
                        "requirement": {
                            "requirement_type": "imaging evidence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No evidence of new CNS hemorrhage on baseline MRI obtained within 14 days before study enrollment (ECHO gradient MRI sequences per institutional guidelines required for evaluation of CNS hemorrhage)",
                "criterions": [
                    {
                        "exact_snippets": "No evidence of new CNS hemorrhage on baseline MRI",
                        "criterion": "CNS hemorrhage",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "baseline MRI obtained within 14 days before study enrollment",
                        "criterion": "baseline MRI timing",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No evidence of new CNS hemorrhage on baseline MRI",
                        "criterion": "CNS hemorrhage",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "baseline MRI obtained within 14 days before study enrollment",
                        "criterion": "baseline MRI timing",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* The presence of small punctuate CNS hemorrhage on these scans will exclude a patient from participation",
                "criterions": [
                    {
                        "exact_snippets": "The presence of small punctuate CNS hemorrhage",
                        "criterion": "CNS hemorrhage",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "The presence of small punctuate CNS hemorrhage",
                        "criterion": "CNS hemorrhage",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": "small"
                        }
                    },
                    {
                        "exact_snippets": "The presence of small punctuate CNS hemorrhage",
                        "criterion": "CNS hemorrhage",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "punctuate"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "The presence of small punctuate CNS hemorrhage",
                                        "criterion": "CNS hemorrhage",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "The presence of small punctuate CNS hemorrhage",
                                        "criterion": "CNS hemorrhage",
                                        "requirement": {
                                            "requirement_type": "size",
                                            "expected_value": "small"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "The presence of small punctuate CNS hemorrhage",
                                "criterion": "CNS hemorrhage",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": "punctuate"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Platelet count ≥ 100,000/mm³ (transfusion independent)*",
                "criterions": [
                    {
                        "exact_snippets": "Platelet count ≥ 100,000/mm³ (transfusion independent)",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm³"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Platelet count ≥ 100,000/mm³ (transfusion independent)",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "transfusion independence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Platelet count ≥ 100,000/mm³ (transfusion independent)",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm³"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Platelet count ≥ 100,000/mm³ (transfusion independent)",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "transfusion independence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Hemoglobin ≥ 8.0 g/dL (transfusions allowed)*",
                "criterions": [
                    {
                        "exact_snippets": "Hemoglobin ≥ 8.0 g/dL",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8.0,
                                "unit": "g/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hemoglobin ≥ 8.0 g/dL",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8.0,
                                "unit": "g/dL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine based on age/gender as follows:",
                "criterions": [
                    {
                        "exact_snippets": "Creatinine clearance ... ≥ 70 mL/min",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "rate",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "mL/min"
                            }
                        }
                    },
                    {
                        "exact_snippets": "radioisotope glomerular filtration rate ≥ 70 mL/min",
                        "criterion": "radioisotope glomerular filtration rate",
                        "requirement": {
                            "requirement_type": "rate",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "mL/min"
                            }
                        }
                    },
                    {
                        "exact_snippets": "creatinine based on age/gender",
                        "criterion": "creatinine",
                        "requirement": {
                            "requirement_type": "based on",
                            "expected_value": [
                                "age",
                                "gender"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Creatinine clearance ... ≥ 70 mL/min",
                                "criterion": "creatinine clearance",
                                "requirement": {
                                    "requirement_type": "rate",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 70,
                                        "unit": "mL/min"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "radioisotope glomerular filtration rate ≥ 70 mL/min",
                                "criterion": "radioisotope glomerular filtration rate",
                                "requirement": {
                                    "requirement_type": "rate",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 70,
                                        "unit": "mL/min"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "creatinine based on age/gender",
                        "criterion": "creatinine",
                        "requirement": {
                            "requirement_type": "based on",
                            "expected_value": [
                                "age",
                                "gender"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No greater than 0.8 mg/dL (2 to 5 years of age)",
                "criterions": [
                    {
                        "exact_snippets": "No greater than 0.8 mg/dL (2 to 5 years of age)",
                        "criterion": "serum creatinine level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 0.8,
                                "unit": "mg/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No greater than 0.8 mg/dL (2 to 5 years of age)",
                        "criterion": "serum creatinine level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 0.8,
                                "unit": "mg/dL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No greater than 1 mg/dL (6 to 9 years of age)",
                "criterions": [
                    {
                        "exact_snippets": "No greater than 1 mg/dL (6 to 9 years of age)",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 6,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 9,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "No greater than 1 mg/dL",
                        "criterion": "measurement",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "mg/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No greater than 1 mg/dL (6 to 9 years of age)",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 6,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 9,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "No greater than 1 mg/dL",
                        "criterion": "measurement",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "mg/dL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No greater than 1.2 mg/dL (10 to 12 years of age)",
                "criterions": [
                    {
                        "exact_snippets": "No greater than 1.2 mg/dL (10 to 12 years of age)",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.2,
                                "unit": "mg/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "No greater than 1.2 mg/dL (10 to 12 years of age)",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "age range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 10,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 12,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No greater than 1.2 mg/dL (10 to 12 years of age)",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.2,
                                "unit": "mg/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "No greater than 1.2 mg/dL (10 to 12 years of age)",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "age range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 10,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 12,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No greater than 1.5 mg/dL (male) OR 1.4 mg/dL (female) (13 to 15 years of age)",
                "criterions": [
                    {
                        "exact_snippets": "No greater than 1.5 mg/dL (male)",
                        "criterion": "serum creatinine level (male)",
                        "requirement": {
                            "requirement_type": "maximum value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "No greater than ... 1.4 mg/dL (female)",
                        "criterion": "serum creatinine level (female)",
                        "requirement": {
                            "requirement_type": "maximum value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.4,
                                "unit": "mg/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "13 to 15 years of age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 13,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 15,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "No greater than 1.5 mg/dL (male)",
                                        "criterion": "serum creatinine level (male)",
                                        "requirement": {
                                            "requirement_type": "maximum value",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 1.5,
                                                "unit": "mg/dL"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "13 to 15 years of age",
                                        "criterion": "age",
                                        "requirement": {
                                            "requirement_type": "range",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": ">=",
                                                        "value": 13,
                                                        "unit": "years"
                                                    },
                                                    {
                                                        "operator": "<=",
                                                        "value": 15,
                                                        "unit": "years"
                                                    }
                                                ]
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "No greater than ... 1.4 mg/dL (female)",
                                        "criterion": "serum creatinine level (female)",
                                        "requirement": {
                                            "requirement_type": "maximum value",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 1.4,
                                                "unit": "mg/dL"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "13 to 15 years of age",
                                        "criterion": "age",
                                        "requirement": {
                                            "requirement_type": "range",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": ">=",
                                                        "value": 13,
                                                        "unit": "years"
                                                    },
                                                    {
                                                        "operator": "<=",
                                                        "value": 15,
                                                        "unit": "years"
                                                    }
                                                ]
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No greater than 1.7 mg/dL (male) OR 1.4 mg/dL (female) (≥ 16 years of age)",
                "criterions": [
                    {
                        "exact_snippets": "No greater than 1.7 mg/dL (male)",
                        "criterion": "serum creatinine level (male)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.7,
                                "unit": "mg/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "No greater than ... 1.4 mg/dL (female)",
                        "criterion": "serum creatinine level (female)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.4,
                                "unit": "mg/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "(≥ 16 years of age)",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 16,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "No greater than 1.7 mg/dL (male)",
                                        "criterion": "serum creatinine level (male)",
                                        "requirement": {
                                            "requirement_type": "value",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 1.7,
                                                "unit": "mg/dL"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "(≥ 16 years of age)",
                                        "criterion": "age",
                                        "requirement": {
                                            "requirement_type": "minimum age",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 16,
                                                "unit": "years"
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "No greater than ... 1.4 mg/dL (female)",
                                        "criterion": "serum creatinine level (female)",
                                        "requirement": {
                                            "requirement_type": "value",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 1.4,
                                                "unit": "mg/dL"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "(≥ 16 years of age)",
                                        "criterion": "age",
                                        "requirement": {
                                            "requirement_type": "minimum age",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 16,
                                                "unit": "years"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Bilirubin ≤ 1.5 times upper limit of normal (ULN)",
                "criterions": [
                    {
                        "exact_snippets": "Bilirubin ≤ 1.5 times upper limit of normal (ULN)",
                        "criterion": "bilirubin level",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Bilirubin ≤ 1.5 times upper limit of normal (ULN)",
                        "criterion": "bilirubin level",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for liver metastases)",
                "criterions": [
                    {
                        "exact_snippets": "ALT and AST ≤ 2.5 times ULN",
                        "criterion": "ALT and AST levels",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "ALT and AST ... ≤ 5 times ULN for liver metastases",
                        "criterion": "ALT and AST levels with liver metastases",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "times ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "ALT and AST ... ≤ 5 times ULN for liver metastases",
                    "criterion": "ALT and AST levels with liver metastases",
                    "requirement": {
                        "requirement_type": "level",
                        "expected_value": {
                            "operator": "<=",
                            "value": 5,
                            "unit": "times ULN"
                        }
                    }
                },
                "then_criteria": {
                    "exact_snippets": "ALT and AST ... ≤ 5 times ULN for liver metastases",
                    "criterion": "ALT and AST levels with liver metastases",
                    "requirement": {
                        "requirement_type": "level",
                        "expected_value": {
                            "operator": "<=",
                            "value": 5,
                            "unit": "times ULN"
                        }
                    }
                },
                "else_criteria": {
                    "exact_snippets": "ALT and AST ≤ 2.5 times ULN",
                    "criterion": "ALT and AST levels",
                    "requirement": {
                        "requirement_type": "level",
                        "expected_value": {
                            "operator": "<=",
                            "value": 2.5,
                            "unit": "times ULN"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Albumin ≥ 2 g/dL",
                "criterions": [
                    {
                        "exact_snippets": "Albumin ≥ 2 g/dL",
                        "criterion": "albumin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "g/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Albumin ≥ 2 g/dL",
                        "criterion": "albumin level",
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                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "g/dL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* LVEF or shortening fraction normal",
                "criterions": [
                    {
                        "exact_snippets": "LVEF or shortening fraction normal",
                        "criterion": "LVEF",
                        "requirement": {
                            "requirement_type": "normality",
                            "expected_value": "normal"
                        }
                    },
                    {
                        "exact_snippets": "LVEF or shortening fraction normal",
                        "criterion": "shortening fraction",
                        "requirement": {
                            "requirement_type": "normality",
                            "expected_value": "normal"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "LVEF or shortening fraction normal",
                        "criterion": "LVEF",
                        "requirement": {
                            "requirement_type": "normality",
                            "expected_value": "normal"
                        }
                    },
                    {
                        "exact_snippets": "LVEF or shortening fraction normal",
                        "criterion": "shortening fraction",
                        "requirement": {
                            "requirement_type": "normality",
                            "expected_value": "normal"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Corrected QT interval ≤ 450 msec",
                "criterions": [
                    {
                        "exact_snippets": "Corrected QT interval ≤ 450 msec",
                        "criterion": "Corrected QT interval",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 450,
                                "unit": "msec"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Corrected QT interval ≤ 450 msec",
                        "criterion": "Corrected QT interval",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 450,
                                "unit": "msec"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Amylase ≤ 1.5 times ULN",
                "criterions": [
                    {
                        "exact_snippets": "Amylase ≤ 1.5 times ULN",
                        "criterion": "amylase level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Amylase ≤ 1.5 times ULN",
                        "criterion": "amylase level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Lipase ≤ 1.5 times ULN",
                "criterions": [
                    {
                        "exact_snippets": "Lipase ≤ 1.5 times ULN",
                        "criterion": "lipase level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Lipase ≤ 1.5 times ULN",
                        "criterion": "lipase level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Body surface area ≥ 0.5 m² (≥ 0.4 m² for part B)",
                "criterions": [
                    {
                        "exact_snippets": "Body surface area ≥ 0.5 m²",
                        "criterion": "body surface area",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 0.5,
                                "unit": "m²"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Body surface area ... (≥ 0.4 m² for part B)",
                        "criterion": "body surface area for part B",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 0.4,
                                "unit": "m²"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Part B",
                    "criterion": "trial part",
                    "requirement": {
                        "requirement_type": "phase",
                        "expected_value": "B"
                    }
                },
                "then_criteria": {
                    "exact_snippets": "Body surface area ... (≥ 0.4 m² for part B)",
                    "criterion": "body surface area for part B",
                    "requirement": {
                        "requirement_type": "size",
                        "expected_value": {
                            "operator": ">=",
                            "value": 0.4,
                            "unit": "m²"
                        }
                    }
                },
                "else_criteria": {
                    "exact_snippets": "Body surface area ≥ 0.5 m²",
                    "criterion": "body surface area",
                    "requirement": {
                        "requirement_type": "size",
                        "expected_value": {
                            "operator": ">=",
                            "value": 0.5,
                            "unit": "m²"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Blood pressure within ULN",
                "criterions": [
                    {
                        "exact_snippets": "Blood pressure within ULN",
                        "criterion": "blood pressure",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": "within ULN"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Blood pressure within ULN",
                        "criterion": "blood pressure",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": "within ULN"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Fertile patients must use effective contraception",
                "criterions": [
                    {
                        "exact_snippets": "Fertile patients",
                        "criterion": "fertility",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    },
                    {
                        "exact_snippets": "must use effective contraception",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
                    "requirement": {
                        "requirement_type": "status",
                        "expected_value": "fertile"
                    }
                },
                "then_criteria": {
                    "exact_snippets": "must use effective contraception",
                    "criterion": "contraception use",
                    "requirement": {
                        "requirement_type": "necessity",
                        "expected_value": true
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* No uncontrolled infection",
                "criterions": [
                    {
                        "exact_snippets": "No uncontrolled infection",
                        "criterion": "infection",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No uncontrolled infection",
                        "criterion": "infection",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Able to swallow sunitinib malate capsules (part A only)",
                "criterions": [
                    {
                        "exact_snippets": "Able to swallow sunitinib malate capsules",
                        "criterion": "ability to swallow sunitinib malate capsules",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Able to swallow sunitinib malate capsules",
                        "criterion": "ability to swallow sunitinib malate capsules",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No pre-existing thyroid abnormality (hyper- or hypothyroidism) with unstable thyroid function",
                "criterions": [
                    {
                        "exact_snippets": "No pre-existing thyroid abnormality (hyper- or hypothyroidism)",
                        "criterion": "thyroid abnormality",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "unstable thyroid function",
                        "criterion": "thyroid function",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": "stable"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No pre-existing thyroid abnormality (hyper- or hypothyroidism)",
                        "criterion": "thyroid abnormality",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "unstable thyroid function",
                        "criterion": "thyroid function",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": "stable"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No history of allergic reaction attributed to sunitinib malate or component of sunitinib malate capsules",
                "criterions": [
                    {
                        "exact_snippets": "No history of allergic reaction attributed to sunitinib malate",
                        "criterion": "allergic reaction to sunitinib malate",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No history of allergic reaction attributed to ... component of sunitinib malate capsules",
                        "criterion": "allergic reaction to component of sunitinib malate capsules",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No history of allergic reaction attributed to sunitinib malate",
                        "criterion": "allergic reaction to sunitinib malate",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No history of allergic reaction attributed to ... component of sunitinib malate capsules",
                        "criterion": "allergic reaction to component of sunitinib malate capsules",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No allergy to both applesauce and yogurt (part B only)",
                "criterions": [
                    {
                        "exact_snippets": "No allergy to both applesauce and yogurt",
                        "criterion": "allergy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No allergy to both applesauce and yogurt",
                        "criterion": "allergy",
                        "requirement": {
                            "requirement_type": "substances",
                            "expected_value": [
                                "applesauce",
                                "yogurt"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "No allergy to both applesauce and yogurt",
                                "criterion": "allergy",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "No allergy to both applesauce and yogurt",
                                "criterion": "allergy",
                                "requirement": {
                                    "requirement_type": "substances",
                                    "expected_value": [
                                        "applesauce",
                                        "yogurt"
                                    ]
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                            }
                        ]
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            "identified_line": {
                "line": "* Recovered from prior therapy",
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                    {
                        "exact_snippets": "Recovered from prior therapy",
                        "criterion": "recovery from prior therapy",
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                            "requirement_type": "status",
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            "logical_structure": {
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                    {
                        "exact_snippets": "Recovered from prior therapy",
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                            "requirement_type": "status",
                            "expected_value": "recovered"
                        }
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                ]
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        {
            "identified_line": {
                "line": "* No prior sunitinib malate",
                "criterions": [
                    {
                        "exact_snippets": "No prior sunitinib malate",
                        "criterion": "prior sunitinib malate",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "No prior sunitinib malate",
                    "criterion": "prior sunitinib malate",
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                        "requirement_type": "presence",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* No prior anthracycline (any dose)",
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                    {
                        "exact_snippets": "No prior anthracycline (any dose)",
                        "criterion": "prior anthracycline",
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                            "requirement_type": "presence",
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                    {
                        "exact_snippets": "No prior anthracycline (any dose)",
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                            "requirement_type": "presence",
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                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No prior radiotherapy to a radiation field that included the heart(including total body or craniospinal irradiation)",
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                    {
                        "exact_snippets": "No prior radiotherapy to a radiation field that included the heart",
                        "criterion": "prior radiotherapy to a radiation field that included the heart",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "(including total body or craniospinal irradiation)",
                        "criterion": "prior total body or craniospinal irradiation",
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                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "No prior radiotherapy to a radiation field that included the heart",
                                "criterion": "prior radiotherapy to a radiation field that included the heart",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "(including total body or craniospinal irradiation)",
                                "criterion": "prior total body or craniospinal irradiation",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
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                ]
            }
        },
        {
            "identified_line": {
                "line": "* At least 3 months since prior stem cell transplantation or rescue (without total-body irradiation) and no evidence of graft-vs-host disease",
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                    {
                        "exact_snippets": "At least 3 months since prior stem cell transplantation or rescue",
                        "criterion": "time since stem cell transplantation or rescue",
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                            "requirement_type": "time since procedure",
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                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "without total-body irradiation",
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                    {
                        "exact_snippets": "no evidence of graft-vs-host disease",
                        "criterion": "graft-vs-host disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
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            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "At least 3 months since prior stem cell transplantation or rescue",
                                "criterion": "time since stem cell transplantation or rescue",
                                "requirement": {
                                    "requirement_type": "time since procedure",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "months"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "without total-body irradiation",
                                "criterion": "total-body irradiation",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
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                    {
                        "exact_snippets": "no evidence of graft-vs-host disease",
                        "criterion": "graft-vs-host disease",
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                    }
                ]
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            "identified_line": {
                "line": "* At least 2 weeks since prior local, palliative, small-port radiotherapy (at least 6 months for radiation to ≥ 50% of pelvis)",
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                        "exact_snippets": "At least 2 weeks since prior local, palliative, small-port radiotherapy",
                        "criterion": "time since prior local, palliative, small-port radiotherapy",
                        "requirement": {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "at least 6 months for radiation to ≥ 50% of pelvis",
                        "criterion": "time since radiation to ≥ 50% of pelvis",
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                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "At least 2 weeks since prior local, palliative, small-port radiotherapy",
                                "criterion": "time since prior local, palliative, small-port radiotherapy",
                                "requirement": {
                                    "requirement_type": "time since treatment",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "weeks"
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                                }
                            }
                        ]
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                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "at least 6 months for radiation to ≥ 50% of pelvis",
                                "criterion": "time since radiation to ≥ 50% of pelvis",
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                                    "requirement_type": "time since treatment",
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                                        "operator": ">=",
                                        "value": 6,
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                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* At least 6 weeks since other prior substantial bone marrow radiotherapy",
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                    {
                        "exact_snippets": "At least 6 weeks since other prior substantial bone marrow radiotherapy",
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                        "requirement": {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
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            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "At least 6 weeks since other prior substantial bone marrow radiotherapy",
                        "criterion": "time since prior substantial bone marrow radiotherapy",
                        "requirement": {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
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                        }
                    }
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            }
        },
        {
            "identified_line": {
                "line": "* At least 1 week since prior antineoplastic biologic agents",
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                    {
                        "exact_snippets": "At least 1 week since prior antineoplastic biologic agents",
                        "criterion": "time since prior antineoplastic biologic agents",
                        "requirement": {
                            "requirement_type": "time since treatment",
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                                "value": 1,
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                    {
                        "exact_snippets": "At least 1 week since prior antineoplastic biologic agents",
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                            "requirement_type": "time since treatment",
                            "expected_value": {
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                                "value": 1,
                                "unit": "week"
                            }
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                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* At least 1 week since prior and no concurrent hematopoietic growth factors",
                "criterions": [
                    {
                        "exact_snippets": "At least 1 week since prior ... hematopoietic growth factors",
                        "criterion": "hematopoietic growth factors",
                        "requirement": {
                            "requirement_type": "time since prior use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    },
                    {
                        "exact_snippets": "At least 1 week since prior ... hematopoietic growth factors",
                        "criterion": "hematopoietic growth factors",
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                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    }
                ]
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            "logical_structure": {
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                        "exact_snippets": "At least 1 week since prior ... hematopoietic growth factors",
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                                "operator": ">=",
                                "value": 1,
                                "unit": "week"
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                        "exact_snippets": "At least 1 week since prior ... hematopoietic growth factors",
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                ]
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            "identified_line": {
                "line": "* At least 12 days since prior and no concurrent CYP3A4 inducers, including any of the following:",
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                        "exact_snippets": "At least 12 days since prior ... CYP3A4 inducers",
                        "criterion": "CYP3A4 inducers",
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                            "requirement_type": "time since prior use",
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                                "operator": ">=",
                                "value": 12,
                                "unit": "days"
                            }
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                    },
                    {
                        "exact_snippets": "At least 12 days since prior ... CYP3A4 inducers",
                        "criterion": "CYP3A4 inducers",
                        "requirement": {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    }
                ]
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                        "and_criteria": [
                            {
                                "exact_snippets": "At least 12 days since prior ... CYP3A4 inducers",
                                "criterion": "CYP3A4 inducers",
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                                    "requirement_type": "time since prior use",
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                                        "value": 12,
                                        "unit": "days"
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                            {
                                "exact_snippets": "At least 12 days since prior ... CYP3A4 inducers",
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                                "requirement": {
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                                    "expected_value": false
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                "line": "* Rifampin",
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                        "exact_snippets": "Rifampin",
                        "criterion": "Rifampin",
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                            "requirement_type": "presence",
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            "logical_structure": {
                "and_criteria": [
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                        "exact_snippets": "Rifampin",
                        "criterion": "Rifampin",
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                            "requirement_type": "presence",
                            "expected_value": true
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                ]
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        {
            "identified_line": {
                "line": "* Rifabutin",
                "criterions": [
                    {
                        "exact_snippets": "Rifabutin",
                        "criterion": "Rifabutin",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
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                    {
                        "exact_snippets": "Rifabutin",
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                        "exact_snippets": "Carbamazepine",
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                            "requirement_type": "presence",
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                        "exact_snippets": "Carbamazepine",
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                    }
                ]
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        {
            "identified_line": {
                "line": "* Phenobarbital",
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                    {
                        "exact_snippets": "Phenobarbital",
                        "criterion": "Phenobarbital",
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                            "requirement_type": "presence",
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                ]
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            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Phenobarbital",
                        "criterion": "Phenobarbital",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
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                ]
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        },
        {
            "identified_line": {
                "line": "* Phenytoin",
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                    {
                        "exact_snippets": "Phenytoin",
                        "criterion": "Phenytoin",
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                            "requirement_type": "presence",
                            "expected_value": true
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            "identified_line": {
                "line": "* Hypericum perforatum (St. John's wort)",
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                    {
                        "exact_snippets": "Hypericum perforatum (St. John's wort)",
                        "criterion": "Hypericum perforatum (St. John's wort)",
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                            "requirement_type": "presence",
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            "logical_structure": {
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                    "exact_snippets": "Hypericum perforatum (St. John's wort)",
                    "criterion": "Hypericum perforatum (St. John's wort)",
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                        "requirement_type": "presence",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Efavirenz",
                "criterions": [
                    {
                        "exact_snippets": "Efavirenz",
                        "criterion": "Efavirenz",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Efavirenz",
                        "criterion": "Efavirenz",
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                            "requirement_type": "presence",
                            "expected_value": true
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                    }
                ]
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        },
        {
            "identified_line": {
                "line": "* Tipranavir",
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                        "exact_snippets": "Tipranavir",
                        "criterion": "Tipranavir",
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                            "requirement_type": "presence",
                            "expected_value": true
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                    }
                ]
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            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Tipranavir",
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                            "requirement_type": "presence",
                            "expected_value": true
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                    }
                ]
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        },
        {
            "identified_line": {
                "line": "* At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:",
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                    {
                        "exact_snippets": "At least 7 days since prior ... CYP3A4 inhibitors",
                        "criterion": "CYP3A4 inhibitors",
                        "requirement": {
                            "requirement_type": "time since prior use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "At least 7 days since prior ... CYP3A4 inhibitors",
                        "criterion": "CYP3A4 inhibitors",
                        "requirement": {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "At least 7 days since prior ... CYP3A4 inhibitors",
                                "criterion": "CYP3A4 inhibitors",
                                "requirement": {
                                    "requirement_type": "time since prior use",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 7,
                                        "unit": "days"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "At least 7 days since prior ... CYP3A4 inhibitors",
                                "criterion": "CYP3A4 inhibitors",
                                "requirement": {
                                    "requirement_type": "concurrent use",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Azole antifungals (e.g., itraconazole or ketoconazole)",
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                    {
                        "exact_snippets": "Azole antifungals (e.g., itraconazole or ketoconazole)",
                        "criterion": "azole antifungals",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
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            "logical_structure": {
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                    "exact_snippets": "Azole antifungals (e.g., itraconazole or ketoconazole)",
                    "criterion": "azole antifungals",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Clarithromycin",
                "criterions": [
                    {
                        "exact_snippets": "Clarithromycin",
                        "criterion": "Clarithromycin",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
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                    }
                ]
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            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Clarithromycin",
                        "criterion": "Clarithromycin",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
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        },
        {
            "identified_line": {
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                    {
                        "exact_snippets": "Erythromycin",
                        "criterion": "Erythromycin",
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                            "requirement_type": "presence",
                            "expected_value": true
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                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Erythromycin",
                        "criterion": "Erythromycin",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Diltiazem",
                "criterions": [
                    {
                        "exact_snippets": "Diltiazem",
                        "criterion": "Diltiazem",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Diltiazem",
                    "criterion": "Diltiazem",
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                        "requirement_type": "presence",
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                }
            }
        },
        {
            "identified_line": {
                "line": "* Verapamil",
                "criterions": [
                    {
                        "exact_snippets": "Verapamil",
                        "criterion": "Verapamil",
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                            "requirement_type": "presence",
                            "expected_value": true
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                    }
                ]
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            "logical_structure": {
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                    {
                        "exact_snippets": "Verapamil",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* HIV protease inhibitors (e.g., indinavir, saquinavir, ritonavir, atazanavir, or nelfinavir)",
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                    {
                        "exact_snippets": "HIV protease inhibitors (e.g., indinavir, saquinavir, ritonavir, atazanavir, or nelfinavir)",
                        "criterion": "HIV protease inhibitors",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "HIV protease inhibitors (e.g., indinavir, saquinavir, ritonavir, atazanavir, or nelfinavir)",
                    "criterion": "HIV protease inhibitors",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Delavirdine",
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                    {
                        "exact_snippets": "Delavirdine",
                        "criterion": "Delavirdine",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Delavirdine",
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                            "requirement_type": "presence",
                            "expected_value": true
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                ]
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        },
        {
            "identified_line": {
                "line": "* No more than 1 concurrent antihypertensive agent",
                "criterions": [
                    {
                        "exact_snippets": "No more than 1 concurrent antihypertensive agent",
                        "criterion": "concurrent antihypertensive agents",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
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                ]
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                        "exact_snippets": "No more than 1 concurrent antihypertensive agent",
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                        "exact_snippets": "Heparin",
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                        "exact_snippets": "Low molecular weight heparin",
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                        "exact_snippets": "Acetylsalicylic acid (aspirin)",
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                        "exact_snippets": "Acetylsalicylic acid (aspirin)",
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                        "exact_snippets": "Ibuprofen",
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                        "exact_snippets": "Ibuprofen",
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                "line": "* Other nonsteroidal anti-inflammatory drugs",
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                        "exact_snippets": "Other nonsteroidal anti-inflammatory drugs",
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                            "requirement_type": "presence",
                            "expected_value": false
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                    "exact_snippets": "Other nonsteroidal anti-inflammatory drugs",
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                        "requirement_type": "presence",
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                }
            }
        },
        {
            "identified_line": {
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                        "exact_snippets": "No concurrent medication for the treatment of hypertension",
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                            "requirement_type": "presence",
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                    }
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                            "expected_value": false
                        }
                    }
                ]
            }
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                "line": "* No other concurrent investigational drugs",
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                        }
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                ]
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                        "exact_snippets": "No other concurrent investigational drugs",
                        "criterion": "concurrent investigational drugs",
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            "identified_line": {
                "line": "* No other concurrent anticancer agents, including chemotherapy, radiotherapy, immunotherapy, or biologic therapy",
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                        "requirement": {
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                            "expected_value": false
                        }
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                            "expected_value": false
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                        "exact_snippets": "No other concurrent anticancer agents, including ... biologic therapy",
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                            "expected_value": false
                        }
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                        "and_criteria": [
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                                "and_criteria": [
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                                            "expected_value": false
                                        }
                                    },
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                                        "criterion": "concurrent radiotherapy",
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                                            "requirement_type": "presence",
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                                        }
                                    }
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                                "exact_snippets": "No other concurrent anticancer agents, including ... immunotherapy",
                                "criterion": "concurrent immunotherapy",
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                                    "expected_value": false
                                }
                            }
                        ]
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                    {
                        "exact_snippets": "No other concurrent anticancer agents, including ... biologic therapy",
                        "criterion": "concurrent biologic therapy",
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                            "requirement_type": "presence",
                            "expected_value": false
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        },
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            "identified_line": {
                "line": "Healthy volunteers allowed",
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                        "criterion": "volunteer health status",
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                            "requirement_type": "status",
                            "expected_value": "healthy"
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                    }
                ]
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                "and_criteria": [
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                        "exact_snippets": "Healthy volunteers allowed",
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                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 2 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 2 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "Years"
                            }
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                    }
                ]
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            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 2 Years",
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                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "Years"
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        },
        {
            "identified_line": {
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                        "exact_snippets": "maximum age of 21 Years",
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                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 21,
                                "unit": "Years"
                            }
                        }
                    }
                ]
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                    {
                        "exact_snippets": "maximum age of 21 Years",
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                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 21,
                                "unit": "Years"
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                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Not pregnant or nursing",
                "criterions": [
                    {
                        "exact_snippets": "Not pregnant",
                        "criterion": "pregnancy",
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                            "requirement_type": "status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "not ... nursing",
                        "criterion": "nursing",
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                        "exact_snippets": "Not pregnant",
                        "criterion": "pregnancy",
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                            "requirement_type": "status",
                            "expected_value": false
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                        }
                    }
                ]
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        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [],
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        {
            "identified_line": {
                "line": "* Measurable or evaluable disease",
                "criterions": [
                    {
                        "exact_snippets": "Measurable or evaluable disease",
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                            "requirement_type": "measurability",
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                                "evaluable"
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        },
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            "identified_line": {
                "line": "* No known bone marrow metastatic disease",
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                        "exact_snippets": "No known bone marrow metastatic disease",
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                "line": "* No tumors involving the pleural surface",
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                        "exact_snippets": "No tumors involving the pleural surface",
                        "criterion": "tumors involving the pleural surface",
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                "line": "* Karnofsky performance status (PS) 50-100% (> 10 years of age) OR Lansky PS 50-100% (≤ 10 years of age)",
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                                        "operator": ">",
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                                        "operator": ">=",
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                                    {
                                        "operator": "<=",
                                        "value": 100,
                                        "unit": "%"
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                            }
                        }
                    },
                    {
                        "exact_snippets": "Lansky PS 50-100% (≤ 10 years of age)",
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                            "requirement_type": "age",
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                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 10,
                                        "unit": "years"
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                    {
                        "exact_snippets": "Lansky PS 50-100% (≤ 10 years of age)",
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                            "requirement_type": "performance status",
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                                        "operator": ">=",
                                        "value": 50,
                                        "unit": "%"
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                                    {
                                        "operator": "<=",
                                        "value": 100,
                                        "unit": "%"
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                            "expected_value": {
                                "operator": ">=",
                                "value": 1000,
                                "unit": "mm³"
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                            "expected_value": false
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                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
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                        "exact_snippets": "6 weeks for nitrosoureas",
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                                "value": 6,
                                "unit": "weeks"
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                ]
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                            "operator": ">=",
                            "value": 6,
                            "unit": "weeks"
                        }
                    }
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                "then_criteria": null,
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                            "operator": ">=",
                            "value": 3,
                            "unit": "weeks"
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    "failed_miscellaneous": []
}