{
    "info": {
        "nct_id": "NCT01272791",
        "official_title": "A Randomized, Open-Label, Phase 2 Trial of Gemcitabine With or Without Bavituximab in Patients With Previously Untreated Stage IV Pancreatic Cancer",
        "inclusion_criteria": "* Written informed consent has been obtained.\n* Adults of 18 years of age or older with a life expectancy of at least 3 months.\n* Patients with histologically or cytologically documented stage IV ductal adenocarcinoma of the pancreas.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n* Adequate hematologic function (ANC ≥ 1,500 cells/µL; hemoglobin ≥ 9 g/dL, platelets ≥ 100,000/µL).\n* Adequate renal function (serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min).\n* Adequate hepatic function (bilirubin ≤ 1.5 x ULN, ALT ≤ 3 x ULN, AST ≤ 3 x ULN); ALT and AST may be <5 x ULN if due to liver metastases.\n* PT/INR ≤ 1.5 × ULN.\n* aPTT ≤ 1.5 × ULN.\n* Female patients must have a negative urine or serum pregnancy test at screening (pregnancy test not required for patients with bilateral oophorectomy and/or hysterectomy or for those patients who are > 1 year postmenopausal).\n* All patients of reproductive potential must agree to use an approved form of contraception (as determined by the investigator).\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Neuroendocrine tumors (carcinoid, islet cell cancer) of the pancreas.\n* NYHA Class III or IV, cardiac function, myocardial infarction within 6 months prior to Day 1, unstable arrhythmia or symptomatic peripheral arterial vascular disease.\n* Known brain, leptomeningeal or epidural metastases.\n* Radiation therapy within 7 days of Study Day 1, lack of recovery from previous therapeutic radiation, or planned radiation therapy during the study period.\n* Previously received any systemic treatment for pancreatic cancer, including prior neoadjuvant or adjuvant chemotherapy for lower stage disease.\n* Previously malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years.\n* Severe chronic obstructive or other pulmonary disease with hypoxemia.\n* Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1, without complete recovery.\n* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.\n* Ongoing therapy with oral or parenteral anticoagulants; patients on low-dose anticoagulants to maintain patency of lines are eligible.\n* Venous thromboembolic events (e.g. deep vein thrombosis or pulmonary embolism) within 6 months of screening.\n* QTC interval of >470 ms on screening.\n* Long QT syndrome or family history of sudden cardiac death in young family members.\n* Subjects who participated in an investigational drug or device study within 28 days prior to study entry.\n* Known active infection with HIV, hepatitis B, or hepatitis C.\n* Females who are pregnant or breast-feeding.\n* Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.\n* Unwillingness or inability to comply with the study protocol for any reason.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Written informed consent has been obtained.",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent has been obtained.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "obtained",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adults of 18 years of age or older with a life expectancy of at least 3 months.",
            "criterions": [
                {
                    "exact_snippets": "Adults of 18 years of age or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "life expectancy of at least 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with histologically or cytologically documented stage IV ductal adenocarcinoma of the pancreas.",
            "criterions": [
                {
                    "exact_snippets": "histologically or cytologically documented",
                    "criterion": "documentation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "stage IV",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        }
                    ]
                },
                {
                    "exact_snippets": "ductal adenocarcinoma of the pancreas",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "ductal adenocarcinoma of the pancreas"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 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": "* Adequate hematologic function (ANC ≥ 1,500 cells/µL; hemoglobin ≥ 9 g/dL, platelets ≥ 100,000/µL).",
            "criterions": [
                {
                    "exact_snippets": "Adequate hematologic function (ANC ≥ 1,500 cells/µL",
                    "criterion": "ANC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "cells/µL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate hematologic function ... hemoglobin ≥ 9 g/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate hematologic function ... platelets ≥ 100,000/µL",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "/µL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate renal function (serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min).",
            "criterions": [
                {
                    "exact_snippets": "Adequate renal function (serum creatinine ≤ 1.5 mg/dL ...",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate renal function ... calculated creatinine clearance ≥ 60 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PT/INR ≤ 1.5 × ULN.",
            "criterions": [
                {
                    "exact_snippets": "PT/INR ≤ 1.5 × ULN",
                    "criterion": "PT/INR",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* aPTT ≤ 1.5 × ULN.",
            "criterions": [
                {
                    "exact_snippets": "aPTT ≤ 1.5 × ULN",
                    "criterion": "aPTT",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female patients must have a negative urine or serum pregnancy test at screening (pregnancy test not required for patients with bilateral oophorectomy and/or hysterectomy or for those patients who are > 1 year postmenopausal).",
            "criterions": [
                {
                    "exact_snippets": "Female patients",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "negative urine or serum pregnancy test",
                    "criterion": "pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "pregnancy test not required for patients with bilateral oophorectomy",
                    "criterion": "bilateral oophorectomy",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pregnancy test not required ... hysterectomy",
                    "criterion": "hysterectomy",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pregnancy test not required ... > 1 year postmenopausal",
                    "criterion": "postmenopausal duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* All patients of reproductive potential must agree to use an approved form of contraception (as determined by the investigator).",
            "criterions": [
                {
                    "exact_snippets": "All patients of reproductive potential",
                    "criterion": "reproductive potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to use an approved form of contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Neuroendocrine tumors (carcinoid, islet cell cancer) of the pancreas.",
            "criterions": [
                {
                    "exact_snippets": "Neuroendocrine tumors (carcinoid, islet cell cancer) of the pancreas.",
                    "criterion": "neuroendocrine tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Neuroendocrine tumors (carcinoid, islet cell cancer) of the pancreas.",
                    "criterion": "carcinoid",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Neuroendocrine tumors (carcinoid, islet cell cancer) of the pancreas.",
                    "criterion": "islet cell cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Neuroendocrine tumors (carcinoid, islet cell cancer) of the pancreas.",
                    "criterion": "pancreas",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* NYHA Class III or IV, cardiac function, myocardial infarction within 6 months prior to Day 1, unstable arrhythmia or symptomatic peripheral arterial vascular disease.",
            "criterions": [
                {
                    "exact_snippets": "NYHA Class III or IV",
                    "criterion": "NYHA class",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac function",
                    "criterion": "cardiac function",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction within 6 months prior to Day 1",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable arrhythmia",
                    "criterion": "arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic peripheral arterial vascular disease",
                    "criterion": "peripheral arterial vascular disease",
                    "requirements": [
                        {
                            "requirement_type": "symptom presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known brain, leptomeningeal or epidural metastases.",
            "criterions": [
                {
                    "exact_snippets": "Known brain ... metastases.",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known ... leptomeningeal ... metastases.",
                    "criterion": "leptomeningeal metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known ... epidural metastases.",
                    "criterion": "epidural metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Radiation therapy within 7 days of Study Day 1, lack of recovery from previous therapeutic radiation, or planned radiation therapy during the study period.",
            "criterions": [
                {
                    "exact_snippets": "Radiation therapy within 7 days of Study Day 1",
                    "criterion": "radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 7,
                                "unit": "days from Study Day 1"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "lack of recovery from previous therapeutic radiation",
                    "criterion": "recovery from previous therapeutic radiation",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "planned radiation therapy during the study period",
                    "criterion": "planned radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "during the study period"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previously received any systemic treatment for pancreatic cancer, including prior neoadjuvant or adjuvant chemotherapy for lower stage disease.",
            "criterions": [
                {
                    "exact_snippets": "Previously received any systemic treatment for pancreatic cancer",
                    "criterion": "systemic treatment for pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "including prior neoadjuvant or adjuvant chemotherapy for lower stage disease",
                    "criterion": "neoadjuvant or adjuvant chemotherapy for lower stage pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previously malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years.",
            "criterions": [
                {
                    "exact_snippets": "Previously malignancies",
                    "criterion": "previous malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated non-melanoma skin cancer",
                    "criterion": "non-melanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in situ cancer",
                    "criterion": "in situ cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other cancer ... disease-free for at least 5 years",
                    "criterion": "other cancer",
                    "requirements": [
                        {
                            "requirement_type": "disease-free duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe chronic obstructive or other pulmonary disease with hypoxemia.",
            "criterions": [
                {
                    "exact_snippets": "Severe chronic obstructive or other pulmonary disease",
                    "criterion": "pulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "hypoxemia",
                    "criterion": "hypoxemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1, without complete recovery.",
            "criterions": [
                {
                    "exact_snippets": "Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "without complete recovery",
                    "criterion": "recovery from surgery",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "incomplete"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.",
            "criterions": [
                {
                    "exact_snippets": "Active, uncontrolled bacterial, viral, or fungal infections",
                    "criterion": "bacterial infections",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "activity status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "Active, uncontrolled bacterial, viral, or fungal infections",
                    "criterion": "viral infections",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "activity status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "Active, uncontrolled bacterial, viral, or fungal infections",
                    "criterion": "fungal infections",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "activity status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring systemic therapy",
                    "criterion": "systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ongoing therapy with oral or parenteral anticoagulants; patients on low-dose anticoagulants to maintain patency of lines are eligible.",
            "criterions": [
                {
                    "exact_snippets": "Ongoing therapy with oral or parenteral anticoagulants",
                    "criterion": "ongoing anticoagulant therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients on low-dose anticoagulants to maintain patency of lines are eligible",
                    "criterion": "low-dose anticoagulant therapy",
                    "requirements": [
                        {
                            "requirement_type": "purpose",
                            "expected_value": "maintain patency of lines"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Venous thromboembolic events (e.g. deep vein thrombosis or pulmonary embolism) within 6 months of screening.",
            "criterions": [
                {
                    "exact_snippets": "Venous thromboembolic events (e.g. deep vein thrombosis or pulmonary embolism) within 6 months of screening.",
                    "criterion": "venous thromboembolic events",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* QTC interval of >470 ms on screening.",
            "criterions": [
                {
                    "exact_snippets": "QTC interval of >470 ms",
                    "criterion": "QTC interval",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 470,
                                "unit": "ms"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Long QT syndrome or family history of sudden cardiac death in young family members.",
            "criterions": [
                {
                    "exact_snippets": "Long QT syndrome",
                    "criterion": "Long QT syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "family history of sudden cardiac death in young family members",
                    "criterion": "family history of sudden cardiac death",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects who participated in an investigational drug or device study within 28 days prior to study entry.",
            "criterions": [
                {
                    "exact_snippets": "Subjects who participated in an investigational drug or device study within 28 days prior to study entry.",
                    "criterion": "participation in investigational study",
                    "requirements": [
                        {
                            "requirement_type": "time since participation",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known active infection with HIV, hepatitis B, or hepatitis C.",
            "criterions": [
                {
                    "exact_snippets": "Known active infection with HIV",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known active infection with ... hepatitis B",
                    "criterion": "hepatitis B infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known active infection with ... hepatitis C",
                    "criterion": "hepatitis C infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Females who are pregnant or breast-feeding.",
            "criterions": [
                {
                    "exact_snippets": "Females who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Females who are ... breast-feeding",
                    "criterion": "breast-feeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.",
            "criterions": [
                {
                    "exact_snippets": "Concomitant disease or condition that could interfere with the conduct of the study",
                    "criterion": "concomitant disease or condition",
                    "requirements": [
                        {
                            "requirement_type": "interference with study",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Concomitant disease or condition ... that would, in the opinion of the investigator, pose an unacceptable risk to the subject",
                    "criterion": "concomitant disease or condition",
                    "requirements": [
                        {
                            "requirement_type": "risk to subject",
                            "expected_value": "unacceptable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unwillingness or inability to comply with the study protocol for any reason.",
            "criterions": [
                {
                    "exact_snippets": "Unwillingness ... to comply with the study protocol",
                    "criterion": "willingness to comply with study protocol",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "inability to comply with the study protocol",
                    "criterion": "ability to comply with study protocol",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Adequate hepatic function (bilirubin ≤ 1.5 x ULN, ALT ≤ 3 x ULN, AST ≤ 3 x ULN); ALT and AST may be <5 x ULN if due to liver metastases.",
            "criterions": [
                {
                    "exact_snippets": "bilirubin ≤ 1.5 x ULN",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT ≤ 3 x ULN; ALT and AST may be <5 x ULN if due to liver metastases",
                    "criterion": "ALT level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "x ULN"
                            }
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST ≤ 3 x ULN; ALT and AST may be <5 x ULN if due to liver metastases",
                    "criterion": "AST level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "x ULN"
                            }
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}