{
    "info": {
        "nct_id": "NCT00560482",
        "official_title": "Phase II Randomized Double Blind Placebo-Controlled Study to Determine the Efficacy of ABR-215050 in Asymptomatic Patients With Metastatic Castrate-Resistant Prostate Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion criteria:\n\n* Histologically confirmed diagnosis of adenocarcinoma of the prostate\n* Asymptomatic metastatic CRPC (VAS pain score less than or equal to 3). The patient may take non-opioid analgesics for non-cancer pain discomfort\n* Evidence of metastatic disease from CT or Bone scan\n* Evidence of progressive disease after castration levels of testosterone have been achieved defined by any of the following criteria:\n\n  * Increased serum prostate-specific antigen (PSA) levels (Confirmed by 3 consecutive PSA measurements within 1 year with at least 14 days between each measurement)\n  * Progression of bidimensionally measurable soft tissue (nodal) metastasis: (CT scan or MRI)\n  * Progression of bone disease: (New bone lesions by bone scan within the past 12 weeks)\n* Castrate levels of serum testosterone (less than or equal to 50 ng/dL or 1.7 nmol/L. Testosterone levels will not be required for patients who have had bilateral orchiectomy)\n* Karnofsky score 70-100\n* Laboratory values as follows:\n\n  * Hb greater than or equal to 90g/L (greater than or equal to 9g/dL)\n  * Serum creatinine less than or equal to 1.5 x upper limit of normal (ULN)\n  * Total bilirubin less than or equal to 1.5 x ULN\n  * AST (SGOT) / ALT (SGPT) less than or equal to 2.5 x ULN\n  * Serum amylase less than or equal to ULN. (If serum amylase is greater than ULN, pancreatic amylase and serum lipase should be analyzed. If both pancreatic amylase and serum lipase is greater than ULN, exclude patient)\n* Patient if sexually active with partner of child bearing potential will agree to use adequate contraceptive methods (barrier contraceptive with spermicide or vasectomy) while on study drug\n* No evidence (greater than or equal to 5 years) of prior malignancies (except successfully treated basal cell, squamous cell carcinoma of the skin)\n* Ability to administer and retain oral medication\n* Able to adhere to the study visit schedule and other protocol requirements\n\nExclusion criteria:\n\n* Prior cytotoxic chemotherapy within 3 years\n* Previous anti-cancer therapy using biologics or vaccines within the last 6 months. Previous treatment with bevacizumab is not allowed.\n* Any treatment modalities, involving radiation and surgery, not discontinued at least 4 weeks prior to treatment in this study\n* Myocardial infarction or any acute coronary syndrome within one year or current uncontrolled arrhythmias, symptomatic uncontrolled congestive heart failure, unstable angina pectoris, uncontrolled hypertension\n* History of pancreatitis\n* Any condition, including the presence of laboratory abnormalities, which confounds the ability to interpret data from the study or places the patient at unacceptable risk if he participates in the study\n* Concurrent use of other anti-cancer agents or treatments [a stable dose of LHRH agonists, bicalutamide (e.g. Casodex) and/or other antiandrogens is allowed]\n* Known brain metastases\n* Simultaneous participation in any other study involving investigational drugs or having participated in a study less than 4 weeks prior to start of study treatment\n* Concomitant systemic treatment with warfarin and/or corticosteroids corresponding to a prednisolone dose above 5 mg/day\n* Exposure to ketoconazole or other strong CYP3A4 inhibitors or inducers intravenously or orally within 14 days prior to inclusion\n* Known positive serology for HIV (patients with known history of HIV will be excluded because of potential for unforeseen toxicity and morbidity in an immunocompromised host)\n* Chronic hepatitis with advanced, decompensated hepatic disease or cirrhosis of the liver or history of a chronic virus hepatitis or known viral hepatitis carrier (patients recovered from hepatitis will be allowed to enter the study)"
    },
    "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 be MALE",
            "criterions": [
                {
                    "exact_snippets": "Must be MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "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": [],
    "miscellaneous_lines": [
        {
            "line": "* Histologically confirmed diagnosis of adenocarcinoma of the prostate",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed diagnosis of adenocarcinoma of the prostate",
                    "criterion": "adenocarcinoma of the prostate",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Asymptomatic metastatic CRPC (VAS pain score less than or equal to 3). The patient may take non-opioid analgesics for non-cancer pain discomfort",
            "criterions": [
                {
                    "exact_snippets": "Asymptomatic metastatic CRPC",
                    "criterion": "metastatic CRPC",
                    "requirements": [
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "asymptomatic"
                        }
                    ]
                },
                {
                    "exact_snippets": "VAS pain score less than or equal to 3",
                    "criterion": "VAS pain score",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "The patient may take non-opioid analgesics for non-cancer pain discomfort",
                    "criterion": "analgesic use",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "non-opioid"
                        },
                        {
                            "requirement_type": "purpose",
                            "expected_value": "non-cancer pain discomfort"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of metastatic disease from CT or Bone scan",
            "criterions": [
                {
                    "exact_snippets": "Evidence of metastatic disease from CT",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "detection method",
                            "expected_value": "CT"
                        }
                    ]
                },
                {
                    "exact_snippets": "Evidence of metastatic disease from ... Bone scan",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "detection method",
                            "expected_value": "Bone scan"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of progressive disease after castration levels of testosterone have been achieved defined by any of the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "Evidence of progressive disease",
                    "criterion": "progressive disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "castration levels of testosterone have been achieved",
                    "criterion": "testosterone levels",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "castration levels"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Increased serum prostate-specific antigen (PSA) levels (Confirmed by 3 consecutive PSA measurements within 1 year with at least 14 days between each measurement)",
            "criterions": [
                {
                    "exact_snippets": "Increased serum prostate-specific antigen (PSA) levels",
                    "criterion": "serum prostate-specific antigen (PSA) levels",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "increased"
                        }
                    ]
                },
                {
                    "exact_snippets": "Confirmed by 3 consecutive PSA measurements within 1 year with at least 14 days between each measurement",
                    "criterion": "PSA measurements",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "3 consecutive measurements within 1 year with at least 14 days between each"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Progression of bidimensionally measurable soft tissue (nodal) metastasis: (CT scan or MRI)",
            "criterions": [
                {
                    "exact_snippets": "Progression of bidimensionally measurable soft tissue (nodal) metastasis",
                    "criterion": "soft tissue (nodal) metastasis",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "measurability",
                            "expected_value": "bidimensional"
                        }
                    ]
                },
                {
                    "exact_snippets": "(CT scan or MRI)",
                    "criterion": "imaging modality",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "CT scan",
                                "MRI"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Progression of bone disease: (New bone lesions by bone scan within the past 12 weeks)",
            "criterions": [
                {
                    "exact_snippets": "Progression of bone disease: (New bone lesions by bone scan within the past 12 weeks)",
                    "criterion": "bone disease progression",
                    "requirements": [
                        {
                            "requirement_type": "new lesions",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "detection method",
                            "expected_value": "bone scan"
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the past 12 weeks"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Castrate levels of serum testosterone (less than or equal to 50 ng/dL or 1.7 nmol/L. Testosterone levels will not be required for patients who have had bilateral orchiectomy)",
            "criterions": [
                {
                    "exact_snippets": "Castrate levels of serum testosterone (less than or equal to 50 ng/dL or 1.7 nmol/L",
                    "criterion": "serum testosterone",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 50,
                                        "unit": "ng/dL"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1.7,
                                        "unit": "nmol/L"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Testosterone levels will not be required for patients who have had bilateral orchiectomy",
                    "criterion": "bilateral orchiectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Karnofsky score 70-100",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky score 70-100",
                    "criterion": "Karnofsky score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 70,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 100,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Laboratory values as follows:",
            "criterions": [
                {
                    "exact_snippets": "Laboratory values",
                    "criterion": "laboratory values",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "as follows"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hb greater than or equal to 90g/L (greater than or equal to 9g/dL)",
            "criterions": [
                {
                    "exact_snippets": "Hb greater than or equal to 90g/L (greater than or equal to 9g/dL)",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 90,
                                        "unit": "g/L"
                                    },
                                    {
                                        "operator": ">=",
                                        "value": 9,
                                        "unit": "g/dL"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine less than or equal to 1.5 x upper limit of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine less than or equal to 1.5 x upper limit of normal (ULN)",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin less than or equal to 1.5 x ULN",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin less than or equal to 1.5 x ULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST (SGOT) / ALT (SGPT) less than or equal to 2.5 x ULN",
            "criterions": [
                {
                    "exact_snippets": "AST (SGOT) / ALT (SGPT) less than or equal to 2.5 x ULN",
                    "criterion": "AST (SGOT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST (SGOT) / ALT (SGPT) less than or equal to 2.5 x ULN",
                    "criterion": "ALT (SGPT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum amylase less than or equal to ULN. (If serum amylase is greater than ULN, pancreatic amylase and serum lipase should be analyzed. If both pancreatic amylase and serum lipase is greater than ULN, exclude patient)",
            "criterions": [
                {
                    "exact_snippets": "Serum amylase less than or equal to ULN",
                    "criterion": "serum amylase",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "pancreatic amylase ... greater than ULN",
                    "criterion": "pancreatic amylase",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum lipase ... greater than ULN",
                    "criterion": "serum lipase",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient if sexually active with partner of child bearing potential will agree to use adequate contraceptive methods (barrier contraceptive with spermicide or vasectomy) while on study drug",
            "criterions": [
                {
                    "exact_snippets": "Patient if sexually active with partner of child bearing potential",
                    "criterion": "sexual activity with partner of child bearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "will agree to use adequate contraceptive methods (barrier contraceptive with spermicide or vasectomy)",
                    "criterion": "use of contraceptive methods",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "barrier contraceptive with spermicide",
                                "vasectomy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No evidence (greater than or equal to 5 years) of prior malignancies (except successfully treated basal cell, squamous cell carcinoma of the skin)",
            "criterions": [
                {
                    "exact_snippets": "No evidence (greater than or equal to 5 years) of prior malignancies",
                    "criterion": "prior malignancies",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time since last evidence",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except successfully treated basal cell, squamous cell carcinoma of the skin",
                    "criterion": "exceptions to prior malignancies",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "successfully treated basal cell carcinoma of the skin",
                                "successfully treated squamous cell carcinoma of the skin"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to administer and retain oral medication",
            "criterions": [
                {
                    "exact_snippets": "Ability to administer and retain oral medication",
                    "criterion": "oral medication",
                    "requirements": [
                        {
                            "requirement_type": "ability to administer",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability to retain",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to adhere to the study visit schedule and other protocol requirements",
            "criterions": [
                {
                    "exact_snippets": "Able to adhere to the study visit schedule",
                    "criterion": "adherence to study visit schedule",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Able to adhere to ... other protocol requirements",
                    "criterion": "adherence to protocol requirements",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior cytotoxic chemotherapy within 3 years",
            "criterions": [
                {
                    "exact_snippets": "Prior cytotoxic chemotherapy within 3 years",
                    "criterion": "prior cytotoxic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous anti-cancer therapy using biologics or vaccines within the last 6 months. Previous treatment with bevacizumab is not allowed.",
            "criterions": [
                {
                    "exact_snippets": "Previous anti-cancer therapy using biologics or vaccines within the last 6 months.",
                    "criterion": "previous anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "biologics",
                                "vaccines"
                            ]
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous treatment with bevacizumab is not allowed.",
                    "criterion": "previous treatment with bevacizumab",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any treatment modalities, involving radiation and surgery, not discontinued at least 4 weeks prior to treatment in this study",
            "criterions": [
                {
                    "exact_snippets": "treatment modalities, involving radiation and surgery, not discontinued at least 4 weeks prior to treatment in this study",
                    "criterion": "treatment modalities",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation period",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Myocardial infarction or any acute coronary syndrome within one year or current uncontrolled arrhythmias, symptomatic uncontrolled congestive heart failure, unstable angina pectoris, uncontrolled hypertension",
            "criterions": [
                {
                    "exact_snippets": "Myocardial infarction or any acute coronary syndrome within one year",
                    "criterion": "myocardial infarction or acute coronary syndrome",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "year"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "current uncontrolled arrhythmias",
                    "criterion": "arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic uncontrolled congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "symptoms",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina pectoris",
                    "criterion": "angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of pancreatitis",
            "criterions": [
                {
                    "exact_snippets": "History of pancreatitis",
                    "criterion": "pancreatitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any condition, including the presence of laboratory abnormalities, which confounds the ability to interpret data from the study or places the patient at unacceptable risk if he participates in the study",
            "criterions": [
                {
                    "exact_snippets": "Any condition, including the presence of laboratory abnormalities",
                    "criterion": "condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "places the patient at unacceptable risk",
                    "criterion": "risk",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "unacceptable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent use of other anti-cancer agents or treatments [a stable dose of LHRH agonists, bicalutamide (e.g. Casodex) and/or other antiandrogens is allowed]",
            "criterions": [
                {
                    "exact_snippets": "Concurrent use of other anti-cancer agents or treatments",
                    "criterion": "concurrent use of anti-cancer agents or treatments",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "a stable dose of LHRH agonists, bicalutamide (e.g. Casodex) and/or other antiandrogens is allowed",
                    "criterion": "use of LHRH agonists, bicalutamide, and/or other antiandrogens",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "stable dose"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known brain metastases",
            "criterions": [
                {
                    "exact_snippets": "Known brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Simultaneous participation in any other study involving investigational drugs or having participated in a study less than 4 weeks prior to start of study treatment",
            "criterions": [
                {
                    "exact_snippets": "Simultaneous participation in any other study involving investigational drugs",
                    "criterion": "simultaneous participation in other study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "having participated in a study less than 4 weeks prior to start of study treatment",
                    "criterion": "prior participation in a study",
                    "requirements": [
                        {
                            "requirement_type": "time since participation",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concomitant systemic treatment with warfarin and/or corticosteroids corresponding to a prednisolone dose above 5 mg/day",
            "criterions": [
                {
                    "exact_snippets": "Concomitant systemic treatment with warfarin",
                    "criterion": "concomitant systemic treatment",
                    "requirements": [
                        {
                            "requirement_type": "medication",
                            "expected_value": "warfarin"
                        }
                    ]
                },
                {
                    "exact_snippets": "Concomitant systemic treatment with ... corticosteroids corresponding to a prednisolone dose above 5 mg/day",
                    "criterion": "concomitant systemic treatment",
                    "requirements": [
                        {
                            "requirement_type": "medication",
                            "expected_value": "corticosteroids"
                        },
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "mg/day"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Exposure to ketoconazole or other strong CYP3A4 inhibitors or inducers intravenously or orally within 14 days prior to inclusion",
            "criterions": [
                {
                    "exact_snippets": "Exposure to ketoconazole or other strong CYP3A4 inhibitors or inducers",
                    "criterion": "exposure to strong CYP3A4 inhibitors or inducers",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 14,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known positive serology for HIV (patients with known history of HIV will be excluded because of potential for unforeseen toxicity and morbidity in an immunocompromised host)",
            "criterions": [
                {
                    "exact_snippets": "Known positive serology for HIV",
                    "criterion": "HIV serology",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Chronic hepatitis with advanced, decompensated hepatic disease or cirrhosis of the liver or history of a chronic virus hepatitis or known viral hepatitis carrier (patients recovered from hepatitis will be allowed to enter the study)",
            "criterions": [
                {
                    "exact_snippets": "Chronic hepatitis",
                    "criterion": "chronic hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced, decompensated hepatic disease",
                    "criterion": "advanced, decompensated hepatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cirrhosis of the liver",
                    "criterion": "cirrhosis of the liver",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of a chronic virus hepatitis",
                    "criterion": "history of chronic viral hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known viral hepatitis carrier",
                    "criterion": "known viral hepatitis carrier",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Inclusion criteria:",
            "criterions": []
        },
        {
            "line": "Exclusion criteria:",
            "criterions": []
        }
    ]
}