{
    "info": {
        "nct_id": "NCT01752920",
        "official_title": "A Phase 1/2 Study of ARQ 087 in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations, Including Intrahepatic Cholangiocarcinoma With FGFR2 Gene Fusion",
        "inclusion_criteria": "1. Signed written informed consent granted\n2. Men or women ≥18 years of age\n3. Histologically or cytologically confirmed, locally advanced, inoperable, or metastatic solid tumors. Patients eligible for enrollment in the Expanded Cohort must have documented and/or confirmed FGFR genetic aberrations, including iCCA with FGFR2 gene fusion.\n4. Failure to respond to standard therapy, or for whom standard therapy does not exist.\n5. Evaluable or measurable disease\n6. Archival and/or fresh biopsy tissue samples must be available prior to the first dose of the study drug\n7. Life expectancy ≥ 12 weeks\n8. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n9. Hemoglobin (Hgb) ≥ 9.0 g/dL\n10. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L\n11. Platelet count ≥ 100 x 10^9/L\n12. Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (≤ 2 x ULN for patients with cholangiocarcinoma)\n13. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 × ULN (≤ 5 x ULN for patients with liver metastases)\n14. Serum creatinine ≤ 1.5 x ULN or creatinine clearance > 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal\n15. Albumin ≥ 2.8 g/dL\n16. INR 0.8 to ULN or ≤ 3 for patients receiving anticoagulant therapy\n17. Men or women of child-producing potential must agree to use double-barrier contraceptive measures, oral contraception, or avoid intercourse during the study and for 90 days after the last dose of study drug\n18. Women of childbearing potential must have a negative serum pregnancy test during Screening Period and within 48 hours of the first dose of derazantinib.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Anti-cancer therapy, such as chemotherapy, immunotherapy, hormonal, targeted therapy, or investigational agents within four weeks or five times of the drug half life, whichever is longer, of the first dose of derazantinib\n2. Major surgery or radiation therapy within four weeks of the first dose of derazantinib\n3. Previous treatment with FGFR inhibitors\n4. History of allergic reactions attributed to compounds of similar chemical or biological composition as derazantinib\n5. Unable or unwilling to swallow the complete daily dose of derazantinib\n6. Clinically unstable central nervous system (CNS) metastasis\n7. History of myocardial infarction (MI) or congestive heart failure defined as Class II to IV per the New York Heart Association classification within 6 months of the first dose of derazantinib (MI occurring >6 months of the first dose of derazantinib will be permitted)\n8. Significant GI disorder(s) that could interfere with the absorption, metabolism, or excretion of derazantinib (e.g. Crohn's disease, ulcerative colitis, extensive gastric resection)\n9. History and/or current evidence of clinically relevant ectopic mineralization/calcification\n10. Previous malignancy within 2 years prior to the first dose of derazantinib, except curatively treated non-melanoma skin cancer, carcinoma in-situ of the breast or cervix, or superficial bladder tumors\n11. Known human immunodeficiency virus (HIV) infection\n12. Concurrent uncontrolled illness not related to cancer, including but not limited to:\n\n    * Psychiatric illness/substance abuse/social situation that would limit compliance with study requirements.\n    * Uncontrolled diabetes mellitus\n13. Blood transfusion within 5 days of the blood draw being used to confirm eligibility\n14. Pregnant or breastfeeding",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Signed written informed consent granted",
            "criterions": [
                {
                    "exact_snippets": "Signed written informed consent granted",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Men or women ≥18 years of age",
            "criterions": [
                {
                    "exact_snippets": "Men or women",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "≥18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Histologically or cytologically confirmed, locally advanced, inoperable, or metastatic solid tumors. Patients eligible for enrollment in the Expanded Cohort must have documented and/or confirmed FGFR genetic aberrations, including iCCA with FGFR2 gene fusion.",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed",
                    "criterion": "solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced, inoperable, or metastatic",
                    "criterion": "solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "inoperable",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "documented and/or confirmed FGFR genetic aberrations",
                    "criterion": "FGFR genetic aberrations",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "documented",
                                "confirmed"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "iCCA with FGFR2 gene fusion",
                    "criterion": "iCCA",
                    "requirements": [
                        {
                            "requirement_type": "genetic fusion",
                            "expected_value": "FGFR2"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Failure to respond to standard therapy, or for whom standard therapy does not exist.",
            "criterions": [
                {
                    "exact_snippets": "Failure to respond to standard therapy",
                    "criterion": "response to standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "for whom standard therapy does not exist",
                    "criterion": "availability of standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Evaluable or measurable disease",
            "criterions": [
                {
                    "exact_snippets": "Evaluable or measurable disease",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "evaluability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Archival and/or fresh biopsy tissue samples must be available prior to the first dose of the study drug",
            "criterions": [
                {
                    "exact_snippets": "Archival and/or fresh biopsy tissue samples must be available",
                    "criterion": "biopsy tissue samples",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Life expectancy ≥ 12 weeks",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy ≥ 12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Hemoglobin (Hgb) ≥ 9.0 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin (Hgb) ≥ 9.0 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Platelet count ≥ 100 x 10^9/L",
            "criterions": [
                {
                    "exact_snippets": "Platelet count ≥ 100 x 10^9/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (≤ 2 x ULN for patients with cholangiocarcinoma)",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin ≤ 1.5 × upper limit of normal (ULN)",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Total bilirubin ... (≤ 2 x ULN for patients with cholangiocarcinoma)",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 × ULN (≤ 5 x ULN for patients with liver metastases)",
            "criterions": [
                {
                    "exact_snippets": "Aspartate transaminase (AST) ... ≤ 3 × ULN (≤ 5 x ULN for patients with liver metastases)",
                    "criterion": "aspartate transaminase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine transaminase (ALT) ... ≤ 3 × ULN (≤ 5 x ULN for patients with liver metastases)",
                    "criterion": "alanine transaminase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Aspartate transaminase (AST) and alanine transaminase (ALT) ... ≤ 5 x ULN for patients with liver metastases",
                    "criterion": "aspartate transaminase (AST) and alanine transaminase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Serum creatinine ≤ 1.5 x ULN or creatinine clearance > 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine ≤ 1.5 x ULN",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance > 60 mL/min/1.73 m^2",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "mL/min/1.73 m^2"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Albumin ≥ 2.8 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Albumin ≥ 2.8 g/dL",
                    "criterion": "albumin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2.8,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. INR 0.8 to ULN or ≤ 3 for patients receiving anticoagulant therapy",
            "criterions": [
                {
                    "exact_snippets": "INR 0.8 to ULN",
                    "criterion": "INR",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0.8,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "INR ... ≤ 3 for patients receiving anticoagulant therapy",
                    "criterion": "INR for patients receiving anticoagulant therapy",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Men or women of child-producing potential must agree to use double-barrier contraceptive measures, oral contraception, or avoid intercourse during the study and for 90 days after the last dose of study drug",
            "criterions": [
                {
                    "exact_snippets": "Men or women of child-producing potential",
                    "criterion": "child-producing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to use double-barrier contraceptive measures, oral contraception, or avoid intercourse during the study and for 90 days after the last dose of study drug",
                    "criterion": "contraceptive measures",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Women of childbearing potential must have a negative serum pregnancy test during Screening Period and within 48 hours of the first dose of derazantinib.",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential",
                    "criterion": "women of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must have a negative serum pregnancy test",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "during Screening Period",
                    "criterion": "serum pregnancy test timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "during Screening Period"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 48 hours of the first dose of derazantinib",
                    "criterion": "serum pregnancy test timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 48 hours of the first dose of derazantinib"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Anti-cancer therapy, such as chemotherapy, immunotherapy, hormonal, targeted therapy, or investigational agents within four weeks or five times of the drug half life, whichever is longer, of the first dose of derazantinib",
            "criterions": [
                {
                    "exact_snippets": "Anti-cancer therapy, such as chemotherapy, immunotherapy, hormonal, targeted therapy, or investigational agents within four weeks or five times of the drug half life, whichever is longer, of the first dose of derazantinib",
                    "criterion": "anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": "within four weeks or five times of the drug half life, whichever is longer, of the first dose of derazantinib"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Major surgery or radiation therapy within four weeks of the first dose of derazantinib",
            "criterions": [
                {
                    "exact_snippets": "Major surgery ... within four weeks of the first dose of derazantinib",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "radiation therapy within four weeks of the first dose of derazantinib",
                    "criterion": "radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Previous treatment with FGFR inhibitors",
            "criterions": [
                {
                    "exact_snippets": "Previous treatment with FGFR inhibitors",
                    "criterion": "previous treatment with FGFR inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. History of allergic reactions attributed to compounds of similar chemical or biological composition as derazantinib",
            "criterions": [
                {
                    "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biological composition as derazantinib",
                    "criterion": "allergic reactions",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "attribution",
                            "expected_value": "compounds of similar chemical or biological composition as derazantinib"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Unable or unwilling to swallow the complete daily dose of derazantinib",
            "criterions": [
                {
                    "exact_snippets": "Unable or unwilling to swallow the complete daily dose of derazantinib",
                    "criterion": "ability to swallow medication",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Clinically unstable central nervous system (CNS) metastasis",
            "criterions": [
                {
                    "exact_snippets": "Clinically unstable central nervous system (CNS) metastasis",
                    "criterion": "central nervous system (CNS) metastasis",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "clinically unstable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. History of myocardial infarction (MI) or congestive heart failure defined as Class II to IV per the New York Heart Association classification within 6 months of the first dose of derazantinib (MI occurring >6 months of the first dose of derazantinib will be permitted)",
            "criterions": [
                {
                    "exact_snippets": "History of myocardial infarction (MI)",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure defined as Class II to IV per the New York Heart Association classification",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "Class"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "Class"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "within 6 months of the first dose of derazantinib",
                    "criterion": "time since myocardial infarction or congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "MI occurring >6 months of the first dose of derazantinib will be permitted",
                    "criterion": "time since myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Significant GI disorder(s) that could interfere with the absorption, metabolism, or excretion of derazantinib (e.g. Crohn's disease, ulcerative colitis, extensive gastric resection)",
            "criterions": [
                {
                    "exact_snippets": "Significant GI disorder(s) that could interfere with the absorption, metabolism, or excretion of derazantinib",
                    "criterion": "GI disorder",
                    "requirements": [
                        {
                            "requirement_type": "significance",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "interference",
                            "expected_value": [
                                "absorption",
                                "metabolism",
                                "excretion"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Crohn's disease",
                    "criterion": "Crohn's disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ulcerative colitis",
                    "criterion": "ulcerative colitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "extensive gastric resection",
                    "criterion": "extensive gastric resection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. History and/or current evidence of clinically relevant ectopic mineralization/calcification",
            "criterions": [
                {
                    "exact_snippets": "History and/or current evidence of clinically relevant ectopic mineralization/calcification",
                    "criterion": "ectopic mineralization/calcification",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "clinical relevance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Previous malignancy within 2 years prior to the first dose of derazantinib, except curatively treated non-melanoma skin cancer, carcinoma in-situ of the breast or cervix, or superficial bladder tumors",
            "criterions": [
                {
                    "exact_snippets": "Previous malignancy within 2 years prior to the first dose of derazantinib",
                    "criterion": "previous malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except curatively treated non-melanoma skin cancer",
                    "criterion": "curatively treated non-melanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... carcinoma in-situ of the breast or cervix",
                    "criterion": "carcinoma in-situ of the breast or cervix",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... superficial bladder tumors",
                    "criterion": "superficial bladder tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Known human immunodeficiency virus (HIV) infection",
            "criterions": [
                {
                    "exact_snippets": "Known human immunodeficiency virus (HIV) infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Concurrent uncontrolled illness not related to cancer, including but not limited to:",
            "criterions": [
                {
                    "exact_snippets": "Concurrent uncontrolled illness not related to cancer",
                    "criterion": "uncontrolled illness",
                    "requirements": [
                        {
                            "requirement_type": "relation to cancer",
                            "expected_value": "not related"
                        },
                        {
                            "requirement_type": "concurrent",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Psychiatric illness/substance abuse/social situation that would limit compliance with study requirements.",
            "criterions": [
                {
                    "exact_snippets": "Psychiatric illness",
                    "criterion": "psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": "would limit compliance with study requirements"
                        }
                    ]
                },
                {
                    "exact_snippets": "substance abuse",
                    "criterion": "substance abuse",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": "would limit compliance with study requirements"
                        }
                    ]
                },
                {
                    "exact_snippets": "social situation",
                    "criterion": "social situation",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": "would limit compliance with study requirements"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled diabetes mellitus",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled diabetes mellitus",
                    "criterion": "diabetes mellitus",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Blood transfusion within 5 days of the blood draw being used to confirm eligibility",
            "criterions": [
                {
                    "exact_snippets": "Blood transfusion within 5 days of the blood draw",
                    "criterion": "blood transfusion",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Pregnant or breastfeeding",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}