{
    "info": {
        "nct_id": "NCT02691793",
        "official_title": "Study to Evaluate the Safety and Efficacy of Sunitinib, in Subject With Refractory Solid Tumors",
        "inclusion_criteria": "* Provision of fully informed consent prior to study specific procedures.\n* Patients must be >= 19 years of age\n* RET fusion positive or FGFR2 fusion/other FGFR mutation Refractory solid tumor and/or specific sensitivity to Sunitinib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.\n* ECOG Performance status0-2\n* Have measurable or evaluated disease based on RECIST 1.1 as determined by investigator.\n* Adequate Organ Function Laboratory values\n\n  * Absolute neutrophil count >= 1.5 x 109/L, Hemoglobin >= 9g/dL, Platelets>=100 x 109/L Bilirubin <= 1.5 x upper limit of normal AST/ALT <= 2.5 X upper limit of normal(5.0 x upper limit of normal, for subject with liver metastases) Creatinine<= 1.5 X UNL\n* Patients of child-bearing potential should be using adequate contraceptive measures should not be breast feeding and must have a negative pregnancy test prior to start of dosing\n* Adequate heart function\nHealthy volunteers allowed\nMust have minimum age of 19 Years",
        "exclusion_criteria": "* Patients with second primary cancer, except:adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumor curatively treated with no evidence of disease for <= 5 years.\n* Has known active central nervous system(CNS) metastases\n* Has an active infection requiring systemic therapy\n* Pregnancy or breast feeding\n* Patients with cardiac problem\n* Any previous treatment with sunitinib",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Provision of fully informed consent prior to study specific procedures.",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Provision of fully informed consent"
                        ],
                        "criterion": "informed consent",
                        "requirement_type": "provision",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Provision of fully informed consent"
                        ],
                        "criterion": "informed consent",
                        "requirement_type": "provision",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must be >= 19 years of age",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Patients must be >= 19 years of age"
                        ],
                        "criterion": "age",
                        "requirement_type": "range",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 19
                                }
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": [
                            "Patients must be >= 19 years of age"
                        ],
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                        "requirement_type": "range",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 19
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* ECOG Performance status0-2",
                "criterions": [
                    {
                        "exact_snippets": [
                            "ECOG Performance status",
                            "0-2"
                        ],
                        "criterion": "ECOG Performance status",
                        "requirement_type": "range",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 0
                                },
                                {
                                    "operator": "<=",
                                    "value": 2
                                }
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "ECOG Performance status",
                            "0-2"
                        ],
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                        "requirement_type": "range",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 0
                                },
                                {
                                    "operator": "<=",
                                    "value": 2
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Have measurable or evaluated disease based on RECIST 1.1 as determined by investigator.",
                "criterions": [
                    {
                        "exact_snippets": [
                            "measurable or evaluated disease"
                        ],
                        "criterion": "disease",
                        "requirement_type": "measurability",
                        "expected_value": [
                            "measurable",
                            "evaluated"
                        ]
                    },
                    {
                        "exact_snippets": [
                            "based on RECIST 1.1"
                        ],
                        "criterion": "RECIST 1.1",
                        "requirement_type": "compliance",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "as determined by investigator"
                        ],
                        "criterion": "investigator determination",
                        "requirement_type": "necessity",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": [
                                    "measurable or evaluated disease"
                                ],
                                "criterion": "disease",
                                "requirement_type": "measurability",
                                "expected_value": "measurable"
                            },
                            {
                                "exact_snippets": [
                                    "measurable or evaluated disease"
                                ],
                                "criterion": "disease",
                                "requirement_type": "measurability",
                                "expected_value": "evaluated"
                            }
                        ]
                    },
                    {
                        "exact_snippets": [
                            "based on RECIST 1.1"
                        ],
                        "criterion": "RECIST 1.1",
                        "requirement_type": "compliance",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "as determined by investigator"
                        ],
                        "criterion": "investigator determination",
                        "requirement_type": "necessity",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adequate Organ Function Laboratory values",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Adequate Organ Function Laboratory values"
                        ],
                        "criterion": "organ function",
                        "requirement_type": "adequacy",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Adequate Organ Function Laboratory values"
                        ],
                        "criterion": "organ function",
                        "requirement_type": "adequacy",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Absolute neutrophil count >= 1.5 x 109/L, Hemoglobin >= 9g/dL, Platelets>=100 x 109/L Bilirubin <= 1.5 x upper limit of normal AST/ALT <= 2.5 X upper limit of normal(5.0 x upper limit of normal, for subject with liver metastases) Creatinine<= 1.5 X UNL",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Absolute neutrophil count >= 1.5 x 109/L"
                        ],
                        "criterion": "absolute neutrophil count",
                        "requirement_type": "quantity",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 1.5
                                }
                            ]
                        }
                    },
                    {
                        "exact_snippets": [
                            "Hemoglobin >= 9g/dL"
                        ],
                        "criterion": "hemoglobin",
                        "requirement_type": "quantity",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 9
                                }
                            ]
                        }
                    },
                    {
                        "exact_snippets": [
                            "Platelets>=100 x 109/L"
                        ],
                        "criterion": "platelets",
                        "requirement_type": "quantity",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 100
                                }
                            ]
                        }
                    },
                    {
                        "exact_snippets": [
                            "Bilirubin <= 1.5 x upper limit of normal"
                        ],
                        "criterion": "bilirubin",
                        "requirement_type": "quantity",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": "<=",
                                    "value": 1.5
                                }
                            ]
                        }
                    },
                    {
                        "exact_snippets": [
                            "AST/ALT <= 2.5 X upper limit of normal"
                        ],
                        "criterion": "AST/ALT",
                        "requirement_type": "quantity",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": "<=",
                                    "value": 2.5
                                }
                            ]
                        }
                    },
                    {
                        "exact_snippets": [
                            "AST/ALT <= 2.5 X upper limit of normal",
                            "(5.0 x upper limit of normal, for subject with liver metastases)"
                        ],
                        "criterion": "AST/ALT",
                        "requirement_type": "quantity",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": "<=",
                                    "value": 5.0
                                }
                            ]
                        }
                    },
                    {
                        "exact_snippets": [
                            "Creatinine<= 1.5 X UNL"
                        ],
                        "criterion": "creatinine",
                        "requirement_type": "quantity",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": "<=",
                                    "value": 1.5
                                }
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": [
                                    "Absolute neutrophil count >= 1.5 x 109/L"
                                ],
                                "criterion": "absolute neutrophil count",
                                "requirement_type": "quantity",
                                "expected_value": {
                                    "comparisons": [
                                        {
                                            "operator": ">=",
                                            "value": 1.5
                                        }
                                    ]
                                }
                            },
                            {
                                "exact_snippets": [
                                    "Hemoglobin >= 9g/dL"
                                ],
                                "criterion": "hemoglobin",
                                "requirement_type": "quantity",
                                "expected_value": {
                                    "comparisons": [
                                        {
                                            "operator": ">=",
                                            "value": 9
                                        }
                                    ]
                                }
                            },
                            {
                                "exact_snippets": [
                                    "Platelets>=100 x 109/L"
                                ],
                                "criterion": "platelets",
                                "requirement_type": "quantity",
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                                    "comparisons": [
                                        {
                                            "operator": ">=",
                                            "value": 100
                                        }
                                    ]
                                }
                            },
                            {
                                "exact_snippets": [
                                    "Bilirubin <= 1.5 x upper limit of normal"
                                ],
                                "criterion": "bilirubin",
                                "requirement_type": "quantity",
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                                    "comparisons": [
                                        {
                                            "operator": "<=",
                                            "value": 1.5
                                        }
                                    ]
                                }
                            },
                            {
                                "exact_snippets": [
                                    "Creatinine<= 1.5 X UNL"
                                ],
                                "criterion": "creatinine",
                                "requirement_type": "quantity",
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                                    "comparisons": [
                                        {
                                            "operator": "<=",
                                            "value": 1.5
                                        }
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                                }
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                    },
                    {
                        "condition": {
                            "exact_snippets": [
                                "AST/ALT <= 2.5 X upper limit of normal",
                                "(5.0 x upper limit of normal, for subject with liver metastases)"
                            ],
                            "criterion": "liver metastases",
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        "then_criteria": {
                            "exact_snippets": [
                                "AST/ALT <= 2.5 X upper limit of normal",
                                "(5.0 x upper limit of normal, for subject with liver metastases)"
                            ],
                            "criterion": "AST/ALT",
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5.0
                                    }
                                ]
                            }
                        },
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                                "AST/ALT <= 2.5 X upper limit of normal"
                            ],
                            "criterion": "AST/ALT",
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients of child-bearing potential should be using adequate contraceptive measures should not be breast feeding and must have a negative pregnancy test prior to start of dosing",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Patients of child-bearing potential"
                        ],
                        "criterion": "child-bearing potential",
                        "requirement_type": "presence",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "using adequate contraceptive measures"
                        ],
                        "criterion": "contraceptive measures",
                        "requirement_type": "usage",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "should not be breast feeding"
                        ],
                        "criterion": "breast feeding",
                        "requirement_type": "status",
                        "expected_value": false
                    },
                    {
                        "exact_snippets": [
                            "must have a negative pregnancy test"
                        ],
                        "criterion": "pregnancy test",
                        "requirement_type": "result",
                        "expected_value": "negative"
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": [
                        "Patients of child-bearing potential"
                    ],
                    "criterion": "child-bearing potential",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                "then_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": [
                                "using adequate contraceptive measures"
                            ],
                            "criterion": "contraceptive measures",
                            "requirement_type": "usage",
                            "expected_value": true
                        },
                        {
                            "exact_snippets": [
                                "should not be breast feeding"
                            ],
                            "criterion": "breast feeding",
                            "requirement_type": "status",
                            "expected_value": false
                        },
                        {
                            "exact_snippets": [
                                "must have a negative pregnancy test"
                            ],
                            "criterion": "pregnancy test",
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Adequate heart function",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Adequate heart function"
                        ],
                        "criterion": "heart function",
                        "requirement_type": "adequacy",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Adequate heart function"
                        ],
                        "criterion": "heart function",
                        "requirement_type": "adequacy",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Healthy volunteers allowed"
                        ],
                        "criterion": "healthy volunteers",
                        "requirement_type": "participation",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Healthy volunteers allowed"
                        ],
                        "criterion": "healthy volunteers",
                        "requirement_type": "participation",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 19 Years",
                "criterions": [
                    {
                        "exact_snippets": [
                            "minimum age of 19 Years"
                        ],
                        "criterion": "age",
                        "requirement_type": "minimum",
                        "expected_value": {
                            "operator": ">=",
                            "value": 19
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "minimum age of 19 Years"
                        ],
                        "criterion": "age",
                        "requirement_type": "minimum",
                        "expected_value": {
                            "operator": ">=",
                            "value": 19
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Patients with second primary cancer, except:adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumor curatively treated with no evidence of disease for <= 5 years.",
                "criterions": [
                    {
                        "exact_snippets": [
                            "second primary cancer"
                        ],
                        "criterion": "second primary cancer",
                        "requirement_type": "presence",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "adequately treated non-melanoma skin cancer"
                        ],
                        "criterion": "non-melanoma skin cancer",
                        "requirement_type": "treatment status",
                        "expected_value": "adequately treated"
                    },
                    {
                        "exact_snippets": [
                            "curatively treated in-situ cancer of the cervix"
                        ],
                        "criterion": "in-situ cancer of the cervix",
                        "requirement_type": "treatment status",
                        "expected_value": "curatively treated"
                    },
                    {
                        "exact_snippets": [
                            "other solid tumor",
                            "curatively treated",
                            "no evidence of disease for <= 5 years"
                        ],
                        "criterion": "other solid tumor",
                        "requirement_type": "treatment status",
                        "expected_value": "curatively treated"
                    },
                    {
                        "exact_snippets": [
                            "other solid tumor",
                            "curatively treated",
                            "no evidence of disease for <= 5 years"
                        ],
                        "criterion": "other solid tumor",
                        "requirement_type": "disease evidence",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": "<=",
                                    "value": 5
                                }
                            ]
                        }
                    }
                ]
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            "logical_structure": {
                "condition": {
                    "exact_snippets": [
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                    ],
                    "criterion": "second primary cancer",
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                    "expected_value": true
                },
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                        {
                            "not_criteria": {
                                "exact_snippets": [
                                    "adequately treated non-melanoma skin cancer"
                                ],
                                "criterion": "non-melanoma skin cancer",
                                "requirement_type": "treatment status",
                                "expected_value": "adequately treated"
                            }
                        },
                        {
                            "not_criteria": {
                                "exact_snippets": [
                                    "curatively treated in-situ cancer of the cervix"
                                ],
                                "criterion": "in-situ cancer of the cervix",
                                "requirement_type": "treatment status",
                                "expected_value": "curatively treated"
                            }
                        },
                        {
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                                "and_criteria": [
                                    {
                                        "exact_snippets": [
                                            "other solid tumor",
                                            "curatively treated",
                                            "no evidence of disease for <= 5 years"
                                        ],
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                                        "requirement_type": "treatment status",
                                        "expected_value": "curatively treated"
                                    },
                                    {
                                        "exact_snippets": [
                                            "other solid tumor",
                                            "curatively treated",
                                            "no evidence of disease for <= 5 years"
                                        ],
                                        "criterion": "other solid tumor",
                                        "requirement_type": "disease evidence",
                                        "expected_value": {
                                            "comparisons": [
                                                {
                                                    "operator": "<=",
                                                    "value": 5
                                                }
                                            ]
                                        }
                                    }
                                ]
                            }
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Has known active central nervous system(CNS) metastases",
                "criterions": [
                    {
                        "exact_snippets": [
                            "known active central nervous system(CNS) metastases"
                        ],
                        "criterion": "central nervous system metastases",
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": [
                        "known active central nervous system(CNS) metastases"
                    ],
                    "criterion": "central nervous system metastases",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            }
        },
        {
            "identified_line": {
                "line": "* Has an active infection requiring systemic therapy",
                "criterions": [
                    {
                        "exact_snippets": [
                            "active infection"
                        ],
                        "criterion": "infection",
                        "requirement_type": "activity",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "requiring systemic therapy"
                        ],
                        "criterion": "systemic therapy",
                        "requirement_type": "necessity",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "active infection"
                        ],
                        "criterion": "infection",
                        "requirement_type": "activity",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "requiring systemic therapy"
                        ],
                        "criterion": "systemic therapy",
                        "requirement_type": "necessity",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Pregnancy or breast feeding",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Pregnancy"
                        ],
                        "criterion": "pregnancy",
                        "requirement_type": "presence",
                        "expected_value": false
                    },
                    {
                        "exact_snippets": [
                            "breast feeding"
                        ],
                        "criterion": "breast feeding",
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": [
                            "Pregnancy"
                        ],
                        "criterion": "pregnancy",
                        "requirement_type": "presence",
                        "expected_value": false
                    },
                    {
                        "exact_snippets": [
                            "breast feeding"
                        ],
                        "criterion": "breast feeding",
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with cardiac problem",
                "criterions": [
                    {
                        "exact_snippets": [
                            "cardiac problem"
                        ],
                        "criterion": "cardiac problem",
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": [
                        "cardiac problem"
                    ],
                    "criterion": "cardiac problem",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            }
        },
        {
            "identified_line": {
                "line": "* Any previous treatment with sunitinib",
                "criterions": [
                    {
                        "exact_snippets": [
                            "previous treatment with sunitinib"
                        ],
                        "criterion": "sunitinib treatment",
                        "requirement_type": "history",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": [
                        "previous treatment with sunitinib"
                    ],
                    "criterion": "sunitinib treatment",
                    "requirement_type": "history",
                    "expected_value": true
                }
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* RET fusion positive or FGFR2 fusion/other FGFR mutation Refractory solid tumor and/or specific sensitivity to Sunitinib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.",
                "criterions": [
                    {
                        "exact_snippets": [
                            "RET fusion positive"
                        ],
                        "criterion": "RET fusion",
                        "requirement_type": "presence",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "FGFR2 fusion/other FGFR mutation"
                        ],
                        "criterion": "FGFR2 fusion",
                        "requirement_type": "presence",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "FGFR2 fusion/other FGFR mutation"
                        ],
                        "criterion": "FGFR mutation",
                        "requirement_type": "presence",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "Refractory solid tumor"
                        ],
                        "criterion": "solid tumor",
                        "requirement_type": "refractory",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "specific sensitivity to Sunitinib by Avatar scan"
                        ],
                        "criterion": "sensitivity to Sunitinib",
                        "requirement_type": "specific",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "progressed following standard therapy"
                        ],
                        "criterion": "progression after standard therapy",
                        "requirement_type": "occurrence",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "has not responded to standard therapy"
                        ],
                        "criterion": "response to standard therapy",
                        "requirement_type": "lack of response",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "for which there is no standard therapy"
                        ],
                        "criterion": "standard therapy availability",
                        "requirement_type": "availability",
                        "expected_value": false
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": [
                    "failed"
                ],
                "criterion": "failed",
                "requirement_type": "failed",
                "expected_value": "failed"
            }
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}