{
    "info": {
        "nct_id": "NCT00068172",
        "official_title": "A Phase I/II Study of PI-88 in Advanced Malignancies (Phase I), and in Advanced Melanoma (Phase II)",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* History of allergy and/or hypersensitivity to anti-coagulants/thrombolytic agents, especially heparin.\n* Chemotherapy, investigational or hormonal therapy in the previous 4 weeks.\n* Radiotherapy to a major bone marrow bearing area such as pelvis, femoral heads, lumbar-sacral spine, within the previous 4 weeks. Radiotherapy to other sites within the past 2 weeks.\n* Uncontrolled infection or serious infection within the past 4 weeks.\n* Clinically significant non-malignant disease.\n* Known HIV infection or AIDS-related illness.\n* Myocardial infarction, stroke or congestive heart failure within the past 3 months.\n* Current symptomatic central nervous system involvement, or active brain or meningeal metastases.\n* Pregnancy, breast feeding, or women of childbearing potential in whom pregnancy cannot be excluded.\n* History of abuse of alcohol, drugs, or other substances.\n* History of acute or chronic gastrointestinal bleeding within the last two years, inflammatory bowel disease, any other abnormal bleeding tendency, or patients at risk of bleeding due to open wounds or planned surgery.\n* Concomitant use of aspirin (more than 100 mg/day), non-steroidal anti-inflammatory drugs (except COX-2 Inhibitors), heparin, low molecular weight heparin or warfarin (more than 1 mg/day) is ongoing or anticipated during the study period. Low-dose aspirin (up to 100 mg/day) or low-dose warfarin (up to 1 mg/day) is permissible.\n* Heparin or low molecular weight heparin within the previous 2 weeks.\n* Not recovered from major surgery if conducted prior to the study.\n* History of heparin-induced thrombocytopenia, immune mediated thrombocytopenia, thrombotic thrombocytopenic purpura or other platelet disease, or laboratory evidence of anti-heparin antibodies.",
        "miscellaneous_criteria": "Inclusion Criteria\n\n* Current diagnosis of metastatic melanoma, where other effective therapy is not available or has failed.\n* Measurable disease. Metastatic lesions must be measurable by MRI or CT, and cutaneous lesions by physical examination.\n* Aged at least 18 years.\n* Have voluntarily given written informed consent to participate in this study.\n* Performance status: ECOG 0 - 2 (Karnofsky 70 -100%)\n* Life expectancy of at least 3 months.\n* Neutrophil count greater than 1.5 x 109/L (1,500/mm3)\n* Calculated creatinine clearance, using the Cockcroft-Gault formula, greater than 60 mL/min. If just below 60 mL/min, then GFR greater than 60 mL/min as determined by EDTA or DTPA scan.\n* Platelet count at least 100 x 109/L (100,000/mm3)\n* Bilirubin less than 1.5 x ULN\n* AST and ALT up to 2 x ULN, except in the presence of liver metastases; up to 5 x ULN.\n* Prothrombin time less than 1.5 x ULN\n* APTT normal (20 - 34 sec)"
    },
    "inclusion_lines": [
        {
            "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": "* History of allergy and/or hypersensitivity to anti-coagulants/thrombolytic agents, especially heparin.",
            "criterions": [
                {
                    "exact_snippets": "History of allergy and/or hypersensitivity to anti-coagulants/thrombolytic agents",
                    "criterion": "allergy and/or hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "especially heparin",
                    "criterion": "allergy and/or hypersensitivity to heparin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Chemotherapy, investigational or hormonal therapy in the previous 4 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy ... in the previous 4 weeks.",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "investigational ... in the previous 4 weeks.",
                    "criterion": "investigational therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hormonal therapy in the previous 4 weeks.",
                    "criterion": "hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Radiotherapy to a major bone marrow bearing area such as pelvis, femoral heads, lumbar-sacral spine, within the previous 4 weeks. Radiotherapy to other sites within the past 2 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Radiotherapy to a major bone marrow bearing area such as pelvis, femoral heads, lumbar-sacral spine, within the previous 4 weeks.",
                    "criterion": "radiotherapy to major bone marrow bearing area",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Radiotherapy to other sites within the past 2 weeks.",
                    "criterion": "radiotherapy to other sites",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled infection or serious infection within the past 4 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "serious infection within the past 4 weeks",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant non-malignant disease.",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant non-malignant disease.",
                    "criterion": "non-malignant disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known HIV infection or AIDS-related illness.",
            "criterions": [
                {
                    "exact_snippets": "Known HIV infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "AIDS-related illness",
                    "criterion": "AIDS-related illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Myocardial infarction, stroke or congestive heart failure within the past 3 months.",
            "criterions": [
                {
                    "exact_snippets": "Myocardial infarction ... within the past 3 months.",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "stroke ... within the past 3 months.",
                    "criterion": "stroke",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure within the past 3 months.",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current symptomatic central nervous system involvement, or active brain or meningeal metastases.",
            "criterions": [
                {
                    "exact_snippets": "Current symptomatic central nervous system involvement",
                    "criterion": "central nervous system involvement",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active brain ... metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active ... meningeal metastases",
                    "criterion": "meningeal metastases",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy, breast feeding, or women of childbearing potential in whom pregnancy cannot be excluded.",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast feeding",
                    "criterion": "breast feeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "women of childbearing potential",
                    "criterion": "women of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "pregnancy exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of abuse of alcohol, drugs, or other substances.",
            "criterions": [
                {
                    "exact_snippets": "History of abuse of alcohol",
                    "criterion": "alcohol abuse",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of abuse of ... drugs",
                    "criterion": "drug abuse",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of abuse of ... other substances",
                    "criterion": "substance abuse",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of acute or chronic gastrointestinal bleeding within the last two years, inflammatory bowel disease, any other abnormal bleeding tendency, or patients at risk of bleeding due to open wounds or planned surgery.",
            "criterions": [
                {
                    "exact_snippets": "History of acute or chronic gastrointestinal bleeding within the last two years",
                    "criterion": "gastrointestinal bleeding",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "inflammatory bowel disease",
                    "criterion": "inflammatory bowel disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any other abnormal bleeding tendency",
                    "criterion": "abnormal bleeding tendency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients at risk of bleeding due to open wounds",
                    "criterion": "risk of bleeding due to open wounds",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients at risk of bleeding due to ... planned surgery",
                    "criterion": "risk of bleeding due to planned surgery",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concomitant use of aspirin (more than 100 mg/day), non-steroidal anti-inflammatory drugs (except COX-2 Inhibitors), heparin, low molecular weight heparin or warfarin (more than 1 mg/day) is ongoing or anticipated during the study period. Low-dose aspirin (up to 100 mg/day) or low-dose warfarin (up to 1 mg/day) is permissible.",
            "criterions": [
                {
                    "exact_snippets": "Concomitant use of aspirin (more than 100 mg/day) ... is ongoing or anticipated during the study period.",
                    "criterion": "concomitant use of aspirin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100,
                                "unit": "mg/day"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Concomitant use of ... non-steroidal anti-inflammatory drugs (except COX-2 Inhibitors) ... is ongoing or anticipated during the study period.",
                    "criterion": "concomitant use of non-steroidal anti-inflammatory drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Concomitant use of ... heparin ... is ongoing or anticipated during the study period.",
                    "criterion": "concomitant use of heparin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Concomitant use of ... low molecular weight heparin ... is ongoing or anticipated during the study period.",
                    "criterion": "concomitant use of low molecular weight heparin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Concomitant use of ... warfarin (more than 1 mg/day) is ongoing or anticipated during the study period.",
                    "criterion": "concomitant use of warfarin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "mg/day"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Heparin or low molecular weight heparin within the previous 2 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Heparin or low molecular weight heparin within the previous 2 weeks.",
                    "criterion": "heparin use",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the previous 2 weeks"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Not recovered from major surgery if conducted prior to the study.",
            "criterions": [
                {
                    "exact_snippets": "Not recovered from major surgery",
                    "criterion": "recovery from major surgery",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of heparin-induced thrombocytopenia, immune mediated thrombocytopenia, thrombotic thrombocytopenic purpura or other platelet disease, or laboratory evidence of anti-heparin antibodies.",
            "criterions": [
                {
                    "exact_snippets": "History of heparin-induced thrombocytopenia",
                    "criterion": "heparin-induced thrombocytopenia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "immune mediated thrombocytopenia",
                    "criterion": "immune mediated thrombocytopenia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "thrombotic thrombocytopenic purpura",
                    "criterion": "thrombotic thrombocytopenic purpura",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other platelet disease",
                    "criterion": "platelet disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "laboratory evidence of anti-heparin antibodies",
                    "criterion": "anti-heparin antibodies",
                    "requirements": [
                        {
                            "requirement_type": "laboratory evidence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [
        {
            "line": "* Current diagnosis of metastatic melanoma, where other effective therapy is not available or has failed.",
            "criterions": [
                {
                    "exact_snippets": "Current diagnosis of metastatic melanoma",
                    "criterion": "metastatic melanoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other effective therapy is not available",
                    "criterion": "effective therapy availability",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other effective therapy ... has failed",
                    "criterion": "effective therapy outcome",
                    "requirements": [
                        {
                            "requirement_type": "outcome",
                            "expected_value": "failed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease. Metastatic lesions must be measurable by MRI or CT, and cutaneous lesions by physical examination.",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease.",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Metastatic lesions must be measurable by MRI or CT",
                    "criterion": "metastatic lesions",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "measurement method",
                            "expected_value": [
                                "MRI",
                                "CT"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "cutaneous lesions by physical examination",
                    "criterion": "cutaneous lesions",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "measurement method",
                            "expected_value": "physical examination"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Aged at least 18 years.",
            "criterions": [
                {
                    "exact_snippets": "Aged at least 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have voluntarily given written informed consent to participate in this study.",
            "criterions": [
                {
                    "exact_snippets": "voluntarily given written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Performance status: ECOG 0 - 2 (Karnofsky 70 -100%)",
            "criterions": [
                {
                    "exact_snippets": "Performance status: ECOG 0 - 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Performance status: ... Karnofsky 70 -100%",
                    "criterion": "Karnofsky performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 70,
                                        "unit": "%"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 100,
                                        "unit": "%"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of at least 3 months.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of at least 3 months.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Neutrophil count greater than 1.5 x 109/L (1,500/mm3)",
            "criterions": [
                {
                    "exact_snippets": "Neutrophil count greater than 1.5 x 109/L (1,500/mm3)",
                    "criterion": "neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Calculated creatinine clearance, using the Cockcroft-Gault formula, greater than 60 mL/min. If just below 60 mL/min, then GFR greater than 60 mL/min as determined by EDTA or DTPA scan.",
            "criterions": [
                {
                    "exact_snippets": "Calculated creatinine clearance ... greater than 60 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "calculation method",
                            "expected_value": "Cockcroft-Gault formula"
                        },
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "GFR greater than 60 mL/min ... EDTA or DTPA scan",
                    "criterion": "GFR",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        },
                        {
                            "requirement_type": "determination method",
                            "expected_value": [
                                "EDTA scan",
                                "DTPA scan"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count at least 100 x 109/L (100,000/mm3)",
            "criterions": [
                {
                    "exact_snippets": "Platelet count at least 100 x 109/L (100,000/mm3)",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 109/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin less than 1.5 x ULN",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin less than 1.5 x ULN",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST and ALT up to 2 x ULN, except in the presence of liver metastases; up to 5 x ULN.",
            "criterions": [
                {
                    "exact_snippets": "AST and ALT up to 2 x ULN",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST and ALT up to 2 x ULN",
                    "criterion": "ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except in the presence of liver metastases; up to 5 x ULN",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except in the presence of liver metastases; up to 5 x ULN",
                    "criterion": "ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except in the presence of liver metastases",
                    "criterion": "liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prothrombin time less than 1.5 x ULN",
            "criterions": [
                {
                    "exact_snippets": "Prothrombin time less than 1.5 x ULN",
                    "criterion": "prothrombin time",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* APTT normal (20 - 34 sec)",
            "criterions": [
                {
                    "exact_snippets": "APTT normal (20 - 34 sec)",
                    "criterion": "APTT",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 20,
                                        "unit": "sec"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 34,
                                        "unit": "sec"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Inclusion Criteria",
            "criterions": []
        }
    ]
}