{
    "info": {
        "nct_id": "NCT03170960",
        "official_title": "A Phase 1b Dose-Escalation Study of Cabozantinib (XL184) Administered Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors",
        "inclusion_criteria": "1. Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent:\n\n   * Dose-Escalation Stage:\n\n     * Subjects with UC (including renal pelvis, ureter, bladder, urethra) after prior platinum-based therapy, or\n     * Subjects with RCC (clear cell, non-clear cell histology) with or without prior systemic anticancer therapy\n   * Expansion Stage:\n\n     * Inoperable locally advanced or metastatic solid tumor (UC, RCC, CRPC, NSCLC, TNBC, OC, EC, HCC, GC/GEJC/LEC, CRC, H&N cancer, and DTC as outlined above)\n2. Measurable disease per RECIST 1.1 as determined by the investigator.\n3. Tumor tissue material available (archival or recent tumor biopsy)\n4. Recovery to baseline or ≤ Grade 1 CTCAE v4 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.\n5. Age eighteen years or older on the day of consent.\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n7. Adequate organ and marrow function.\n8. Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception.\n9. Female subjects of childbearing potential must not be pregnant at screening.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Prior treatment with cabozantinib or immune checkpoint inhibitors including anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 therapy except in Expansion Cohorts 5, 7, 9, 11, 17, 19 and 20. Other restrictions regarding prior therapy may apply.\n2. Known brain metastases or cranial epidural disease unless adequately treated and stable for at least 4 weeks before first dose of study treatment.\n3. Concomitant anticoagulation with oral anticoagulants.\n4. Subject is receiving systemic steroid therapy (>10 mg daily prednisone equivalent) or any other form of immunosuppressive therapy within 2 weeks prior to first dose of study treatment.\n5. Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.\n6. The subject has uncontrolled, significant intercurrent or recent illness, including, but not limited to, an active or history of autoimmune disease or immune deficiency; idiopathic pulmonary fibrosis, organizing pneumonia, pneumonitis; active infection requiring systemic treatment, infection with human immunodeficiency virus (HIV), AIDS-related illness, acute or chronic hepatitis B or C infection, positive test for tuberculosis, moderate to severe hepatic impairment (Child-Pugh B or C).\n7. Pregnant or lactating females.\n8. Previously identified allergy or hypersensitivity to components of the study treatment formulations.\n9. Diagnosis of another malignancy within 2 years before first dose of study treatment.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [],
    "exclusion_lines": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "1. Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent:",
                "criterions": [
                    {
                        "exact_snippets": "Cytologically or histologically ... confirmed solid tumor",
                        "criterion": "solid tumor",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "cytologically",
                                "histologically"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "radiologically confirmed solid tumor",
                        "criterion": "solid tumor",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": "radiologically"
                        }
                    },
                    {
                        "exact_snippets": "solid tumor that is inoperable",
                        "criterion": "solid tumor",
                        "requirement": {
                            "requirement_type": "operability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "solid tumor ... locally advanced",
                        "criterion": "solid tumor",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "locally advanced"
                        }
                    },
                    {
                        "exact_snippets": "solid tumor ... metastatic",
                        "criterion": "solid tumor",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "metastatic"
                        }
                    },
                    {
                        "exact_snippets": "solid tumor ... recurrent",
                        "criterion": "solid tumor",
                        "requirement": {
                            "requirement_type": "recurrence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Dose-Escalation Stage:",
                "criterions": [
                    {
                        "exact_snippets": "Dose-Escalation Stage",
                        "criterion": "dose-escalation stage",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Subjects with UC (including renal pelvis, ureter, bladder, urethra) after prior platinum-based therapy, or",
                "criterions": [
                    {
                        "exact_snippets": "Subjects with UC (including renal pelvis, ureter, bladder, urethra)",
                        "criterion": "urothelial carcinoma (UC)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "after prior platinum-based therapy",
                        "criterion": "prior platinum-based therapy",
                        "requirement": {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Subjects with RCC (clear cell, non-clear cell histology) with or without prior systemic anticancer therapy",
                "criterions": [
                    {
                        "exact_snippets": "Subjects with RCC (clear cell, non-clear cell histology)",
                        "criterion": "RCC histology",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "clear cell",
                                "non-clear cell"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "with or without prior systemic anticancer therapy",
                        "criterion": "prior systemic anticancer therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "with or without prior systemic anticancer therapy",
                        "criterion": "prior systemic anticancer therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Expansion Stage:",
                "criterions": [
                    {
                        "exact_snippets": "Expansion Stage",
                        "criterion": "trial stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "Expansion"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Inoperable locally advanced or metastatic solid tumor (UC, RCC, CRPC, NSCLC, TNBC, OC, EC, HCC, GC/GEJC/LEC, CRC, H&N cancer, and DTC as outlined above)",
                "criterions": [
                    {
                        "exact_snippets": "Inoperable locally advanced or metastatic solid tumor",
                        "criterion": "tumor operability",
                        "requirement": {
                            "requirement_type": "operability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "UC, RCC, CRPC, NSCLC, TNBC, OC, EC, HCC, GC/GEJC/LEC, CRC, H&N cancer, and DTC",
                        "criterion": "cancer type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "UC",
                                "RCC",
                                "CRPC",
                                "NSCLC",
                                "TNBC",
                                "OC",
                                "EC",
                                "HCC",
                                "GC/GEJC/LEC",
                                "CRC",
                                "H&N cancer",
                                "DTC"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "2. Measurable disease per RECIST 1.1 as determined by the investigator.",
                "criterions": [
                    {
                        "exact_snippets": "Measurable disease per RECIST 1.1",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "standard",
                            "expected_value": "RECIST 1.1"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "3. Tumor tissue material available (archival or recent tumor biopsy)",
                "criterions": [
                    {
                        "exact_snippets": "Tumor tissue material available",
                        "criterion": "tumor tissue material",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "archival or recent tumor biopsy",
                        "criterion": "tumor biopsy type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "archival",
                                "recent"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "4. Recovery to baseline or ≤ Grade 1 CTCAE v4 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.",
                "criterions": [
                    {
                        "exact_snippets": "Recovery to baseline or ≤ Grade 1 CTCAE v4 from toxicities related to any prior treatments",
                        "criterion": "recovery from treatment-related toxicities",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "CTCAE v4"
                            }
                        }
                    },
                    {
                        "exact_snippets": "unless AE(s) are clinically nonsignificant",
                        "criterion": "adverse events",
                        "requirement": {
                            "requirement_type": "clinical significance",
                            "expected_value": "nonsignificant"
                        }
                    },
                    {
                        "exact_snippets": "stable on supportive therapy",
                        "criterion": "adverse events",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": "stable"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "5. Age eighteen years or older on the day of consent.",
                "criterions": [
                    {
                        "exact_snippets": "Age eighteen years or older",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.",
                        "criterion": "ECOG Performance Status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "7. Adequate organ and marrow function.",
                "criterions": [
                    {
                        "exact_snippets": "Adequate organ and marrow function.",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate organ and marrow function.",
                        "criterion": "marrow function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "8. Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception.",
                "criterions": [
                    {
                        "exact_snippets": "Sexually active fertile subjects",
                        "criterion": "fertility",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception",
                        "criterion": "contraception agreement",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "9. Female subjects of childbearing potential must not be pregnant at screening.",
                "criterions": [
                    {
                        "exact_snippets": "Female subjects of childbearing potential",
                        "criterion": "female subjects of childbearing potential",
                        "requirement": {
                            "requirement_type": "pregnancy status",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "1. Prior treatment with cabozantinib or immune checkpoint inhibitors including anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 therapy except in Expansion Cohorts 5, 7, 9, 11, 17, 19 and 20. Other restrictions regarding prior therapy may apply.",
                "criterions": [
                    {
                        "exact_snippets": "Prior treatment with cabozantinib",
                        "criterion": "prior treatment with cabozantinib",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Prior treatment with ... immune checkpoint inhibitors including anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 therapy",
                        "criterion": "prior treatment with immune checkpoint inhibitors",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "except in Expansion Cohorts 5, 7, 9, 11, 17, 19 and 20",
                        "criterion": "expansion cohort",
                        "requirement": {
                            "requirement_type": "membership",
                            "expected_value": [
                                "5",
                                "7",
                                "9",
                                "11",
                                "17",
                                "19",
                                "20"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "2. Known brain metastases or cranial epidural disease unless adequately treated and stable for at least 4 weeks before first dose of study treatment.",
                "criterions": [
                    {
                        "exact_snippets": "Known brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Known brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    },
                    {
                        "exact_snippets": "Known brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "stability duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "cranial epidural disease",
                        "criterion": "cranial epidural disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "cranial epidural disease",
                        "criterion": "cranial epidural disease",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    },
                    {
                        "exact_snippets": "cranial epidural disease",
                        "criterion": "cranial epidural disease",
                        "requirement": {
                            "requirement_type": "stability duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "3. Concomitant anticoagulation with oral anticoagulants.",
                "criterions": [
                    {
                        "exact_snippets": "Concomitant anticoagulation with oral anticoagulants",
                        "criterion": "concomitant anticoagulation",
                        "requirement": {
                            "requirement_type": "medication type",
                            "expected_value": "oral anticoagulants"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "4. Subject is receiving systemic steroid therapy (>10 mg daily prednisone equivalent) or any other form of immunosuppressive therapy within 2 weeks prior to first dose of study treatment.",
                "criterions": [
                    {
                        "exact_snippets": "Subject is receiving systemic steroid therapy (>10 mg daily prednisone equivalent)",
                        "criterion": "systemic steroid therapy",
                        "requirement": {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg daily prednisone equivalent"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Subject is receiving ... any other form of immunosuppressive therapy within 2 weeks prior to first dose of study treatment",
                        "criterion": "immunosuppressive therapy",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 2 weeks prior to first dose of study treatment"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "5. Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.",
                "criterions": [
                    {
                        "exact_snippets": "Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.",
                        "criterion": "live, attenuated vaccine administration",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 30,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "6. The subject has uncontrolled, significant intercurrent or recent illness, including, but not limited to, an active or history of autoimmune disease or immune deficiency; idiopathic pulmonary fibrosis, organizing pneumonia, pneumonitis; active infection requiring systemic treatment, infection with human immunodeficiency virus (HIV), AIDS-related illness, acute or chronic hepatitis B or C infection, positive test for tuberculosis, moderate to severe hepatic impairment (Child-Pugh B or C).",
                "criterions": [
                    {
                        "exact_snippets": "uncontrolled, significant intercurrent or recent illness",
                        "criterion": "intercurrent or recent illness",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled, significant intercurrent or recent illness",
                        "criterion": "intercurrent or recent illness",
                        "requirement": {
                            "requirement_type": "significance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "active or history of autoimmune disease or immune deficiency",
                        "criterion": "autoimmune disease or immune deficiency",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "history"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "idiopathic pulmonary fibrosis",
                        "criterion": "idiopathic pulmonary fibrosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "organizing pneumonia",
                        "criterion": "organizing pneumonia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "pneumonitis",
                        "criterion": "pneumonitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "active infection requiring systemic treatment",
                        "criterion": "active infection",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "systemic"
                        }
                    },
                    {
                        "exact_snippets": "infection with human immunodeficiency virus (HIV)",
                        "criterion": "HIV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "AIDS-related illness",
                        "criterion": "AIDS-related illness",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "acute or chronic hepatitis B or C infection",
                        "criterion": "hepatitis B or C infection",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "acute",
                                "chronic"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "positive test for tuberculosis",
                        "criterion": "tuberculosis",
                        "requirement": {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "moderate to severe hepatic impairment (Child-Pugh B or C)",
                        "criterion": "hepatic impairment",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": [
                                "moderate",
                                "severe"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "moderate to severe hepatic impairment (Child-Pugh B or C)",
                        "criterion": "hepatic impairment",
                        "requirement": {
                            "requirement_type": "classification",
                            "expected_value": [
                                "Child-Pugh B",
                                "Child-Pugh C"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "7. Pregnant or lactating females.",
                "criterions": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "lactating females",
                        "criterion": "lactation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "8. Previously identified allergy or hypersensitivity to components of the study treatment formulations.",
                "criterions": [
                    {
                        "exact_snippets": "Previously identified allergy or hypersensitivity to components of the study treatment formulations.",
                        "criterion": "allergy or hypersensitivity",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "9. Diagnosis of another malignancy within 2 years before first dose of study treatment.",
                "criterions": [
                    {
                        "exact_snippets": "Diagnosis of another malignancy within 2 years before first dose of study treatment.",
                        "criterion": "another malignancy",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Diagnosis of another malignancy within 2 years before first dose of study treatment.",
                        "criterion": "another malignancy",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_miscellaneous": []
}