{
    "info": {
        "nct_id": "NCT00249301",
        "official_title": "An Open-Label, Dose Escalation Phase 1 Study of MLN8054, a Novel Aurora A Kinase Inhibitor, in Patients With Advanced Solid Tumors",
        "inclusion_criteria": "* Histologically or cytologically confirmed metastatic and/or advanced solid tumors(including lymphomas) for which standard treatment does not offer or no longer offers curative or life-prolonging potential\n* Aged 18 years or more\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Expected survival longer than 3 months from enrollment in the study\n* Radiographically or clinically evaluable tumor; however, measurable disease is not required for participation in this study\n* Suitable venous access for the conduct of blood sampling for MLN8054 PK\n* Recovered from the reversible effects of prior antineoplastic therapy with at least 4 weeks elapsed since the last exposure to cytotoxic chemotherapy or to radiotherapy and at least 6 weeks elapsed since exposure to nitrosoureas or mitomycin C. Patients treated with fully human monoclonal antibodies must not have received treatment with such antibodies for at least 6 weeks, and those treated with chimeric monoclonal antibodies must not have received treatment with such antibodies for at least 4 weeks. Patients treated with noncytotoxic small molecule drugs (eg, tyrosine kinase inhibitors, such as Tarceva, and hormonal agents, such as Femara) must not have received treatment with these drugs for at least 2 weeks before the first dose of MLN8054 is given.\n* Male patients must use an appropriate method of barrier contraception (eg, condoms)and inform any sexual partners that they must also use a reliable method of contraception (eg, birth control pills) during the study and for 21 days after the last dose of study treatment.\n* Female patients must be postmenopausal, surgically sterilized, or willing to use reliable methods of birth control (eg, a hormonal contraceptive, an intrauterine device, diaphragm with spermicide, or abstinence) during the study and for 21 days after the last dose of study treatment.\n* Able to give informed consent before the conduct of any study-related procedure not part of normal medical care and to comply with the protocol\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Pregnant or lactating\n* Major surgery within the 28 days preceding the first dose of study treatment\n* Serious infection within the 28 days before the first dose of study treatment\n* Life-threatening illness unrelated to cancer\n* Ongoing nausea or vomiting of any severity\n* > Grade 1 diarrhea\n* Known GI disease that could interfere with the oral absorption or tolerance of MLN8054\n* Difficulty swallowing capsules\n* Inability to fast overnight before the morning dose of MLN8054 and to remain nothing by mouth ([NPO] except for water and prescribed medications) for 2 hours after each dose of MLN8054\n* Received more than 4 previous cytotoxic chemotherapeutic regimens, including regimens used as adjuvant or neo-adjuvant therapies. There is no limit on the number of noncytotoxic therapies (eg, hormonal and immunologic) that patients may have received. Tyrosine kinase inhibitors (eg, Tarceva and Iressa) are considered noncytotoxic compounds.\n* Prior treatment with high-dose chemotherapy, defined as chemotherapy requiring the use of peripheral blood or bone marrow stem cell support for hematopoietic reconstitution\n* Prior treatment with radiation therapy involving > 25% of the hematopoietically active bone marrow (see Table 15-1 for the distribution of active bone marrow in adults)\n* Clinical and/or radiographic evidence of cerebral metastases. However, patients who have a history of central nervous system (CNS) metastasis but who have no radiographic or clinical evidence of residual tumor (eg, following complete surgical resection) are not excluded from participation in this study.\n* Clinically significant abnormalities or arrhythmias on 12-lead electrocardiogram (ECG) in the opinion of the investigator\n* Known or suspected human immunodeficiency virus (HIV) positive or hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection\n* Known or suspected disorder of bilirubin metabolism or excretion, including, but not limited to, Gilbert's syndrome, Crigler-Najjar syndrome, Dubin-Johnson syndrome, and Rotor syndrome\n* Inclusion in a trial of an investigational drug in the previous 4 weeks\n* Admission of alcohol abuse or an inability to restrict consumption of alcohol to no more than 1 standard unit of alcohol per day during the study and for 21 days from the last dose of study treatment.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically or cytologically confirmed metastatic and/or advanced solid tumors(including lymphomas) for which standard treatment does not offer or no longer offers curative or life-prolonging potential",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed metastatic and/or advanced solid tumors",
                    "criterion": "metastatic and/or advanced solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "including lymphomas",
                    "criterion": "lymphomas",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "for which standard treatment does not offer or no longer offers curative or life-prolonging potential",
                    "criterion": "standard treatment",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": "does not offer or no longer offers curative or life-prolonging potential"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Aged 18 years or more",
            "criterions": [
                {
                    "exact_snippets": "Aged 18 years or more",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Expected survival longer than 3 months from enrollment in the study",
            "criterions": [
                {
                    "exact_snippets": "Expected survival longer than 3 months",
                    "criterion": "expected survival",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Radiographically or clinically evaluable tumor; however, measurable disease is not required for participation in this study",
            "criterions": [
                {
                    "exact_snippets": "Radiographically or clinically evaluable tumor",
                    "criterion": "tumor",
                    "requirements": [
                        {
                            "requirement_type": "evaluable",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "measurable disease is not required",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Suitable venous access for the conduct of blood sampling for MLN8054 PK",
            "criterions": [
                {
                    "exact_snippets": "Suitable venous access for the conduct of blood sampling",
                    "criterion": "venous access",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recovered from the reversible effects of prior antineoplastic therapy with at least 4 weeks elapsed since the last exposure to cytotoxic chemotherapy or to radiotherapy and at least 6 weeks elapsed since exposure to nitrosoureas or mitomycin C. Patients treated with fully human monoclonal antibodies must not have received treatment with such antibodies for at least 6 weeks, and those treated with chimeric monoclonal antibodies must not have received treatment with such antibodies for at least 4 weeks. Patients treated with noncytotoxic small molecule drugs (eg, tyrosine kinase inhibitors, such as Tarceva, and hormonal agents, such as Femara) must not have received treatment with these drugs for at least 2 weeks before the first dose of MLN8054 is given.",
            "criterions": [
                {
                    "exact_snippets": "Recovered from the reversible effects of prior antineoplastic therapy",
                    "criterion": "recovery from reversible effects of prior antineoplastic therapy",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 4 weeks elapsed since the last exposure to cytotoxic chemotherapy",
                    "criterion": "time since last exposure to cytotoxic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 4 weeks elapsed since the last exposure ... to radiotherapy",
                    "criterion": "time since last exposure to radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 6 weeks elapsed since exposure to nitrosoureas",
                    "criterion": "time since exposure to nitrosoureas",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 6 weeks elapsed since exposure to ... mitomycin C",
                    "criterion": "time since exposure to mitomycin C",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients treated with fully human monoclonal antibodies must not have received treatment with such antibodies for at least 6 weeks",
                    "criterion": "time since treatment with fully human monoclonal antibodies",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "those treated with chimeric monoclonal antibodies must not have received treatment with such antibodies for at least 4 weeks",
                    "criterion": "time since treatment with chimeric monoclonal antibodies",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients treated with noncytotoxic small molecule drugs ... must not have received treatment with these drugs for at least 2 weeks",
                    "criterion": "time since treatment with noncytotoxic small molecule drugs",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Male patients must use an appropriate method of barrier contraception (eg, condoms)and inform any sexual partners that they must also use a reliable method of contraception (eg, birth control pills) during the study and for 21 days after the last dose of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Male patients",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "use an appropriate method of barrier contraception (eg, condoms)",
                    "criterion": "barrier contraception usage",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "inform any sexual partners that they must also use a reliable method of contraception (eg, birth control pills)",
                    "criterion": "partner contraception usage",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "during the study and for 21 days after the last dose of study treatment",
                    "criterion": "duration of contraception usage",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "during the study and for 21 days after the last dose of study treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female patients must be postmenopausal, surgically sterilized, or willing to use reliable methods of birth control (eg, a hormonal contraceptive, an intrauterine device, diaphragm with spermicide, or abstinence) during the study and for 21 days after the last dose of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Female patients",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "postmenopausal",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "postmenopausal"
                        }
                    ]
                },
                {
                    "exact_snippets": "surgically sterilized",
                    "criterion": "surgical sterilization",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "sterilized"
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to use reliable methods of birth control",
                    "criterion": "birth control usage",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "reliable methods of birth control (eg, a hormonal contraceptive, an intrauterine device, diaphragm with spermicide, or abstinence)",
                    "criterion": "birth control methods",
                    "requirements": [
                        {
                            "requirement_type": "methods",
                            "expected_value": [
                                "hormonal contraceptive",
                                "intrauterine device",
                                "diaphragm with spermicide",
                                "abstinence"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "during the study and for 21 days after the last dose of study treatment",
                    "criterion": "birth control duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the study and for 21 days after the last dose of study treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to give informed consent before the conduct of any study-related procedure not part of normal medical care and to comply with the protocol",
            "criterions": [
                {
                    "exact_snippets": "Able to give informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "to comply with the protocol",
                    "criterion": "protocol compliance",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "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": "* Pregnant or lactating",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major surgery within the 28 days preceding the first dose of study treatment",
            "criterions": [
                {
                    "exact_snippets": "Major surgery within the 28 days preceding the first dose of study treatment",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious infection within the 28 days before the first dose of study treatment",
            "criterions": [
                {
                    "exact_snippets": "Serious infection within the 28 days before the first dose of study treatment",
                    "criterion": "serious infection",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life-threatening illness unrelated to cancer",
            "criterions": [
                {
                    "exact_snippets": "Life-threatening illness unrelated to cancer",
                    "criterion": "life-threatening illness",
                    "requirements": [
                        {
                            "requirement_type": "relation to cancer",
                            "expected_value": "unrelated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ongoing nausea or vomiting of any severity",
            "criterions": [
                {
                    "exact_snippets": "Ongoing nausea",
                    "criterion": "nausea",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": "ongoing"
                        }
                    ]
                },
                {
                    "exact_snippets": "Ongoing ... vomiting",
                    "criterion": "vomiting",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": "ongoing"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* > Grade 1 diarrhea",
            "criterions": [
                {
                    "exact_snippets": "Grade 1 diarrhea",
                    "criterion": "diarrhea",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "Grade 1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known GI disease that could interfere with the oral absorption or tolerance of MLN8054",
            "criterions": [
                {
                    "exact_snippets": "Known GI disease that could interfere with the oral absorption or tolerance of MLN8054",
                    "criterion": "GI disease",
                    "requirements": [
                        {
                            "requirement_type": "interference with oral absorption or tolerance of MLN8054",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Difficulty swallowing capsules",
            "criterions": [
                {
                    "exact_snippets": "Difficulty swallowing capsules",
                    "criterion": "swallowing ability",
                    "requirements": [
                        {
                            "requirement_type": "difficulty",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability to fast overnight before the morning dose of MLN8054 and to remain nothing by mouth ([NPO] except for water and prescribed medications) for 2 hours after each dose of MLN8054",
            "criterions": [
                {
                    "exact_snippets": "Inability to fast overnight before the morning dose of MLN8054",
                    "criterion": "ability to fast overnight",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "to remain nothing by mouth ([NPO] except for water and prescribed medications) for 2 hours after each dose of MLN8054",
                    "criterion": "ability to remain NPO for 2 hours after dose",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Received more than 4 previous cytotoxic chemotherapeutic regimens, including regimens used as adjuvant or neo-adjuvant therapies. There is no limit on the number of noncytotoxic therapies (eg, hormonal and immunologic) that patients may have received. Tyrosine kinase inhibitors (eg, Tarceva and Iressa) are considered noncytotoxic compounds.",
            "criterions": [
                {
                    "exact_snippets": "Received more than 4 previous cytotoxic chemotherapeutic regimens",
                    "criterion": "previous cytotoxic chemotherapeutic regimens",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "regimens"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "There is no limit on the number of noncytotoxic therapies",
                    "criterion": "noncytotoxic therapies",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "no limit"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment with high-dose chemotherapy, defined as chemotherapy requiring the use of peripheral blood or bone marrow stem cell support for hematopoietic reconstitution",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with high-dose chemotherapy",
                    "criterion": "prior treatment with high-dose chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "chemotherapy requiring the use of peripheral blood or bone marrow stem cell support for hematopoietic reconstitution",
                    "criterion": "chemotherapy requiring stem cell support",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment with radiation therapy involving > 25% of the hematopoietically active bone marrow (see Table 15-1 for the distribution of active bone marrow in adults)",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with radiation therapy involving > 25% of the hematopoietically active bone marrow",
                    "criterion": "prior radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "involvement of hematopoietically active bone marrow",
                            "expected_value": {
                                "operator": ">",
                                "value": 25,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinical and/or radiographic evidence of cerebral metastases. However, patients who have a history of central nervous system (CNS) metastasis but who have no radiographic or clinical evidence of residual tumor (eg, following complete surgical resection) are not excluded from participation in this study.",
            "criterions": [
                {
                    "exact_snippets": "Clinical and/or radiographic evidence of cerebral metastases.",
                    "criterion": "cerebral metastases",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": [
                                "clinical",
                                "radiographic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "patients who have a history of central nervous system (CNS) metastasis ... no radiographic or clinical evidence of residual tumor",
                    "criterion": "residual tumor",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant abnormalities or arrhythmias on 12-lead electrocardiogram (ECG) in the opinion of the investigator",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant abnormalities ... on 12-lead electrocardiogram (ECG)",
                    "criterion": "abnormalities on 12-lead electrocardiogram (ECG)",
                    "requirements": [
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinically significant ... arrhythmias on 12-lead electrocardiogram (ECG)",
                    "criterion": "arrhythmias on 12-lead electrocardiogram (ECG)",
                    "requirements": [
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known or suspected human immunodeficiency virus (HIV) positive or hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection",
            "criterions": [
                {
                    "exact_snippets": "Known or suspected human immunodeficiency virus (HIV) positive",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive or suspected positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis B surface antigen-positive status",
                    "criterion": "hepatitis B surface antigen status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "known or suspected active hepatitis C infection",
                    "criterion": "hepatitis C infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active or suspected active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known or suspected disorder of bilirubin metabolism or excretion, including, but not limited to, Gilbert's syndrome, Crigler-Najjar syndrome, Dubin-Johnson syndrome, and Rotor syndrome",
            "criterions": [
                {
                    "exact_snippets": "Known or suspected disorder of bilirubin metabolism or excretion",
                    "criterion": "disorder of bilirubin metabolism or excretion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Gilbert's syndrome",
                    "criterion": "Gilbert's syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Crigler-Najjar syndrome",
                    "criterion": "Crigler-Najjar syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Dubin-Johnson syndrome",
                    "criterion": "Dubin-Johnson syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Rotor syndrome",
                    "criterion": "Rotor syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inclusion in a trial of an investigational drug in the previous 4 weeks",
            "criterions": [
                {
                    "exact_snippets": "Inclusion in a trial of an investigational drug in the previous 4 weeks",
                    "criterion": "inclusion in a trial of an investigational drug",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Admission of alcohol abuse or an inability to restrict consumption of alcohol to no more than 1 standard unit of alcohol per day during the study and for 21 days from the last dose of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Admission of alcohol abuse",
                    "criterion": "alcohol abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "inability to restrict consumption of alcohol to no more than 1 standard unit of alcohol per day",
                    "criterion": "alcohol consumption",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "standard unit of alcohol per day"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}