{
    "info": {
        "nct_id": "NCT03472560",
        "official_title": "A PHASE 2, OPEN LABEL STUDY TO EVALUATE SAFETY AND CLINICAL ACTIVITY OF AVELUMAB (BAVENCIO (REGISTERED)) IN COMBINATION WITH AXITINIB (INLYTA (REGISTERED)) IN PATIENTS WITH ADVANCED OR METASTATIC PREVIOUSLY TREATED NON-SMALL CELL LUNG CANCER OR TREATMENT NAÏVE CISPLATIN-INELIGIBLE UROTHELIAL CANCER JAVELIN MEDLEY VEGF",
        "inclusion_criteria": "* Non-small cell lung cancer (NSCLC) Cohort: Histologically or cytologically confirmed diagnosis of NSCLC that is locally advanced or metastatic; No activating EGFR mutations, ALK or ROS1 translocations/rearrangements where testing is standard of care; received at least 1 prior platinum-based chemotherapy regimen for locally advanced or metastatic NSCLC; No more than 2 prior lines of systemic therapy for locally advanced or metastatic disease (If disease progression occurred during or within 6 months after neoadjuvant/adjuvant chemotherapy or radiotherapy-chemotherapy, the regimen is counted as 1 prior treatment regimen towards the allowed limit of prior treatment regimens); Checkpoint inhibitor naïve.\n* Urothelial Cancer (UC) Cohort: Histologically or cytologically confirmed diagnosis of transitional cell carcinoma (TCC) of the urothelium (if mixed, more than 50% TCC component) including bladder, urethra, ureters, or renal pelvis that is locally advanced or metastatic; No prior systemic treatment for locally advanced or metastatic disease; Prior neoadjuvant or adjuvant therapy is permitted if disease progression occurred >12 months after the completion of therapy; Checkpoint inhibitor naïve; Ineligible for receiving cisplatin-containing front-line chemotherapy based at least one of the following criteria: ECOG performance status (PS) 2; Renal dysfunction (defined as creatinine-clearance <60 ml/min); Grade 2 peripheral neuropathy; Grade 2 hearing loss (hearing loss measured by audiometry of 25 decibels at two contiguous frequencies).\n* At least 1 measurable lesion by RECIST v1.1 not previously irradiated.\n* Availability of an archival FFPE tumor tissue block from primary diagnosis specimen or metastatic specimen or 15 unstained slides (10 minimum). If an archived sample is not available, a fresh tumor biopsy must be performed.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. For UC patients, ECOG performance 2 is permitted (cisplatin ineligibility criterion)\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Prior immunotherapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-GITR, anti-LAG-3, anti-TIM-3 or anti-CTLA-4 antibody (including ipilimumab).\n* Newly diagnosed brain metastases or known symptomatic brain metastases requiring steroids.\n* Radiologically documented evidence of major blood vessel invasion or encasement by cancer or intratumor cavitation, regardless of tumor histology.\n* Active autoimmune disease (that might deteriorate when receiving an immunostimulatory agent).\n* Current use of immunosuppressive medication (except for those listed in protocol).\n* Known prior severe hypersensitivity to the investigational products /monoclonal antibodies.\n* Known history of immune-mediated colitis, inflammatory bowel disease, immune-mediated pneumonitis, pulmonary fibrosis.\n* NCI CTCAE Grade 3 hemorrhage within 28 days prior to study enrollment.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Non-small cell lung cancer (NSCLC) Cohort: Histologically or cytologically confirmed diagnosis of NSCLC that is locally advanced or metastatic; No activating EGFR mutations, ALK or ROS1 translocations/rearrangements where testing is standard of care; received at least 1 prior platinum-based chemotherapy regimen for locally advanced or metastatic NSCLC; No more than 2 prior lines of systemic therapy for locally advanced or metastatic disease (If disease progression occurred during or within 6 months after neoadjuvant/adjuvant chemotherapy or radiotherapy-chemotherapy, the regimen is counted as 1 prior treatment regimen towards the allowed limit of prior treatment regimens); Checkpoint inhibitor naïve.",
                "criterions": [
                    {
                        "exact_snippets": "Histologically or cytologically confirmed diagnosis of NSCLC",
                        "criterion": "NSCLC diagnosis",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "locally advanced or metastatic",
                        "criterion": "NSCLC stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "No activating EGFR mutations",
                        "criterion": "EGFR mutations",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No ... ALK or ROS1 translocations/rearrangements",
                        "criterion": "ALK or ROS1 translocations/rearrangements",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "received at least 1 prior platinum-based chemotherapy regimen",
                        "criterion": "prior platinum-based chemotherapy",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "regimen"
                            }
                        }
                    },
                    {
                        "exact_snippets": "No more than 2 prior lines of systemic therapy",
                        "criterion": "prior lines of systemic therapy",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "lines"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Checkpoint inhibitor naïve",
                        "criterion": "checkpoint inhibitor exposure",
                        "requirement": {
                            "requirement_type": "exposure",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "and_criteria": [
                                                    {
                                                        "and_criteria": [
                                                            {
                                                                "exact_snippets": "Histologically or cytologically confirmed diagnosis of NSCLC",
                                                                "criterion": "NSCLC diagnosis",
                                                                "requirement": {
                                                                    "requirement_type": "confirmation method",
                                                                    "expected_value": [
                                                                        "histologically",
                                                                        "cytologically"
                                                                    ]
                                                                }
                                                            },
                                                            {
                                                                "exact_snippets": "locally advanced or metastatic",
                                                                "criterion": "NSCLC stage",
                                                                "requirement": {
                                                                    "requirement_type": "stage",
                                                                    "expected_value": [
                                                                        "locally advanced",
                                                                        "metastatic"
                                                                    ]
                                                                }
                                                            }
                                                        ]
                                                    },
                                                    {
                                                        "exact_snippets": "No activating EGFR mutations",
                                                        "criterion": "EGFR mutations",
                                                        "requirement": {
                                                            "requirement_type": "presence",
                                                            "expected_value": false
                                                        }
                                                    }
                                                ]
                                            },
                                            {
                                                "exact_snippets": "No ... ALK or ROS1 translocations/rearrangements",
                                                "criterion": "ALK or ROS1 translocations/rearrangements",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": false
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "received at least 1 prior platinum-based chemotherapy regimen",
                                        "criterion": "prior platinum-based chemotherapy",
                                        "requirement": {
                                            "requirement_type": "quantity",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 1,
                                                "unit": "regimen"
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "No more than 2 prior lines of systemic therapy",
                                "criterion": "prior lines of systemic therapy",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "lines"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Checkpoint inhibitor naïve",
                        "criterion": "checkpoint inhibitor exposure",
                        "requirement": {
                            "requirement_type": "exposure",
                            "expected_value": false
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Urothelial Cancer (UC) Cohort: Histologically or cytologically confirmed diagnosis of transitional cell carcinoma (TCC) of the urothelium (if mixed, more than 50% TCC component) including bladder, urethra, ureters, or renal pelvis that is locally advanced or metastatic; No prior systemic treatment for locally advanced or metastatic disease; Prior neoadjuvant or adjuvant therapy is permitted if disease progression occurred >12 months after the completion of therapy; Checkpoint inhibitor naïve; Ineligible for receiving cisplatin-containing front-line chemotherapy based at least one of the following criteria: ECOG performance status (PS) 2; Renal dysfunction (defined as creatinine-clearance <60 ml/min); Grade 2 peripheral neuropathy; Grade 2 hearing loss (hearing loss measured by audiometry of 25 decibels at two contiguous frequencies).",
                "criterions": [
                    {
                        "exact_snippets": "Histologically or cytologically confirmed diagnosis of transitional cell carcinoma (TCC) of the urothelium",
                        "criterion": "transitional cell carcinoma (TCC) of the urothelium",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "if mixed, more than 50% TCC component",
                        "criterion": "TCC component in mixed carcinoma",
                        "requirement": {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "locally advanced or metastatic",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "No prior systemic treatment for locally advanced or metastatic disease",
                        "criterion": "prior systemic treatment for locally advanced or metastatic disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Prior neoadjuvant or adjuvant therapy is permitted if disease progression occurred >12 months after the completion of therapy",
                        "criterion": "prior neoadjuvant or adjuvant therapy",
                        "requirement": {
                            "requirement_type": "progression time after therapy",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Checkpoint inhibitor naïve",
                        "criterion": "checkpoint inhibitor exposure",
                        "requirement": {
                            "requirement_type": "naïve",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Ineligible for receiving cisplatin-containing front-line chemotherapy",
                        "criterion": "eligibility for cisplatin-containing front-line chemotherapy",
                        "requirement": {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "ECOG performance status (PS) 2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Renal dysfunction (defined as creatinine-clearance <60 ml/min)",
                        "criterion": "renal dysfunction",
                        "requirement": {
                            "requirement_type": "creatinine-clearance",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "ml/min"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Grade 2 peripheral neuropathy",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Grade 2 hearing loss (hearing loss measured by audiometry of 25 decibels at two contiguous frequencies)",
                        "criterion": "hearing loss",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Grade 2 hearing loss (hearing loss measured by audiometry of 25 decibels at two contiguous frequencies)",
                        "criterion": "hearing loss",
                        "requirement": {
                            "requirement_type": "audiometry measurement",
                            "expected_value": {
                                "operator": "=",
                                "value": 25,
                                "unit": "decibels"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* At least 1 measurable lesion by RECIST v1.1 not previously irradiated.",
                "criterions": [
                    {
                        "exact_snippets": "At least 1 measurable lesion by RECIST v1.1",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "At least 1 measurable lesion by RECIST v1.1",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "measurement standard",
                            "expected_value": "RECIST v1.1"
                        }
                    },
                    {
                        "exact_snippets": "not previously irradiated",
                        "criterion": "lesion irradiation history",
                        "requirement": {
                            "requirement_type": "irradiation status",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Availability of an archival FFPE tumor tissue block from primary diagnosis specimen or metastatic specimen or 15 unstained slides (10 minimum). If an archived sample is not available, a fresh tumor biopsy must be performed.",
                "criterions": [
                    {
                        "exact_snippets": "Availability of an archival FFPE tumor tissue block from primary diagnosis specimen or metastatic specimen",
                        "criterion": "archival FFPE tumor tissue block",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "15 unstained slides (10 minimum)",
                        "criterion": "unstained slides",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 10,
                                        "unit": "slides"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "If an archived sample is not available, a fresh tumor biopsy must be performed",
                        "criterion": "fresh tumor biopsy",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. For UC patients, ECOG performance 2 is permitted (cisplatin ineligibility criterion)",
                "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"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "For UC patients, ECOG performance 2 is permitted",
                        "criterion": "ECOG performance status for UC patients",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "2"
                        }
                    }
                ]
            },
            "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": "* Prior immunotherapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-GITR, anti-LAG-3, anti-TIM-3 or anti-CTLA-4 antibody (including ipilimumab).",
                "criterions": [
                    {
                        "exact_snippets": "Prior immunotherapy with an anti-PD-1",
                        "criterion": "prior immunotherapy with anti-PD-1 antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior immunotherapy with an ... anti-PD-L1",
                        "criterion": "prior immunotherapy with anti-PD-L1 antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior immunotherapy with an ... anti-PD-L2",
                        "criterion": "prior immunotherapy with anti-PD-L2 antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior immunotherapy with an ... anti-CD137",
                        "criterion": "prior immunotherapy with anti-CD137 antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior immunotherapy with an ... anti-OX-40",
                        "criterion": "prior immunotherapy with anti-OX-40 antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior immunotherapy with an ... anti-GITR",
                        "criterion": "prior immunotherapy with anti-GITR antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior immunotherapy with an ... anti-LAG-3",
                        "criterion": "prior immunotherapy with anti-LAG-3 antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior immunotherapy with an ... anti-TIM-3",
                        "criterion": "prior immunotherapy with anti-TIM-3 antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior immunotherapy with an ... anti-CTLA-4 antibody (including ipilimumab)",
                        "criterion": "prior immunotherapy with anti-CTLA-4 antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Newly diagnosed brain metastases or known symptomatic brain metastases requiring steroids.",
                "criterions": [
                    {
                        "exact_snippets": "Newly diagnosed brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "diagnosis status",
                            "expected_value": "newly diagnosed"
                        }
                    },
                    {
                        "exact_snippets": "known symptomatic brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "symptomatic status",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "brain metastases requiring steroids",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "treatment requirement",
                            "expected_value": "steroids"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Radiologically documented evidence of major blood vessel invasion or encasement by cancer or intratumor cavitation, regardless of tumor histology.",
                "criterions": [
                    {
                        "exact_snippets": "Radiologically documented evidence of major blood vessel invasion",
                        "criterion": "major blood vessel invasion",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Radiologically documented evidence of ... encasement by cancer",
                        "criterion": "encasement by cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Radiologically documented evidence of ... intratumor cavitation",
                        "criterion": "intratumor cavitation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Active autoimmune disease (that might deteriorate when receiving an immunostimulatory agent).",
                "criterions": [
                    {
                        "exact_snippets": "Active autoimmune disease (that might deteriorate when receiving an immunostimulatory agent)",
                        "criterion": "autoimmune disease",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "Active autoimmune disease (that might deteriorate when receiving an immunostimulatory agent)",
                        "criterion": "autoimmune disease",
                        "requirement": {
                            "requirement_type": "potential to deteriorate with immunostimulatory agent",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Current use of immunosuppressive medication (except for those listed in protocol).",
                "criterions": [
                    {
                        "exact_snippets": "Current use of immunosuppressive medication",
                        "criterion": "immunosuppressive medication use",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Known prior severe hypersensitivity to the investigational products /monoclonal antibodies.",
                "criterions": [
                    {
                        "exact_snippets": "Known prior severe hypersensitivity to the investigational products",
                        "criterion": "hypersensitivity to investigational products",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "Known prior severe hypersensitivity to the investigational products",
                        "criterion": "hypersensitivity to investigational products",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Known prior severe hypersensitivity to ... monoclonal antibodies",
                        "criterion": "hypersensitivity to monoclonal antibodies",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "Known prior severe hypersensitivity to ... monoclonal antibodies",
                        "criterion": "hypersensitivity to monoclonal antibodies",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Known history of immune-mediated colitis, inflammatory bowel disease, immune-mediated pneumonitis, pulmonary fibrosis.",
                "criterions": [
                    {
                        "exact_snippets": "Known history of immune-mediated colitis",
                        "criterion": "immune-mediated colitis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Known history of ... inflammatory bowel disease",
                        "criterion": "inflammatory bowel disease",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Known history of ... immune-mediated pneumonitis",
                        "criterion": "immune-mediated pneumonitis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Known history of ... pulmonary fibrosis",
                        "criterion": "pulmonary fibrosis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* NCI CTCAE Grade 3 hemorrhage within 28 days prior to study enrollment.",
                "criterions": [
                    {
                        "exact_snippets": "NCI CTCAE Grade 3 hemorrhage",
                        "criterion": "hemorrhage",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "NCI CTCAE Grade 3"
                        }
                    },
                    {
                        "exact_snippets": "within 28 days prior to study enrollment",
                        "criterion": "time since hemorrhage",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_miscellaneous": []
}