{
    "info": {
        "nct_id": "NCT00942331",
        "official_title": "A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients With Advanced Transitional Cell Carcinoma",
        "inclusion_criteria": "* Patients must have histologically or cytologically documented metastatic or unresectable transitional cell (urothelial) carcinoma of the urinary tract (renal pelvis, ureter, bladder, prostate, or urethra), with metastatic or locally advanced disease (T4b, N2, N3, or M1); patients must not be candidates for potentially curative surgery or radiotherapy\n\n  * For patients that have had surgical resection prior to study enrollment, residual or unresected disease (measurable and/or unmeasurable) must be evident on post-surgical scans\n* Prior treatment for transitional cell carcinoma (TCC)\n\n  * Patients may not have received combination systemic chemotherapy for metastatic disease\n  * For the purposes of this study, radiosensitizing single agent chemotherapy is not considered prior systemic therapy\n  * Prior neoadjuvant or adjuvant systemic chemotherapy is permissible provided the interval from end of therapy to diagnosis of metastatic disease is at least 1 year\n  * >= 4 weeks since any prior radiation (including palliative) or major surgery and fully recovered\n  * >= 7 days since any minor surgery such as port placement\n  * >= 4 weeks since any intravesical therapy\n  * No prior treatment with bevacizumab or other angiogenesis inhibitors\n* No known history of brain metastases; brain imaging (magnetic resonance imaging [MRI]/computed tomography [CT]) is not required\n* No current congestive heart failure; New York Heart Association (NYHA) class II, III or IV\n* Patients with history of hypertension must be well controlled (< 150/90) on a regimen of anti-hypertensive therapy\n* Patients on full-dose anticoagulants must be on a stable dose of warfarin and have an in-range international normalized ratio (INR) (usually between 2 and 3) or be on a stable dose of low molecular weight (LMW) heparin; patients receiving anti-platelet agents are also eligible; in addition, patients who are on daily prophylactic aspirin or anticoagulation for atrial fibrillation are eligible\n* No significant history of bleeding events or gastrointestinal (GI) perforation\n\n  * Patients with a history of a significant bleeding episode (e.g. hemoptysis, upper or lower GI bleeding, grade 3 or 4 gross hematuria unable to be controlled by trans-urethral resection of the bladder tumor) within 6 months of registration are not eligible\n  * Patients with a history of GI perforation within 12 months of registration are not eligible\n  * Patients with a history of peritoneal carcinomatosis are not eligible\n* No arterial thrombotic events within 6 months of registration, including transient ischemic attack (TIA), cerebrovascular accident (CVA), peripheral arterial thrombus, unstable angina or angina requiring surgical or medical intervention in the past 6 months, or myocardial infarction (MI); patients with clinically significant peripheral artery disease (i.e., claudication on less than one block) are ineligible\n* Patients who have experienced a deep venous thrombosis or pulmonary embolus within the past 6 months must be on stable therapeutic anticoagulation to be enrolled to this study\n* No serious or non-healing wound, ulcer, or bone fracture\n* No sensory or motor peripheral neuropathy >= grade 2\n* Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies are not eligible\n* Patients that are pregnant or nursing are not eligible; women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours prior to registration\n\n  * For women of child-bearing potential with an elevated beta-HCG that is believed to be related to cancer and not pregnancy, a negative trans-vaginal ultrasound and gynecological examination are required\n  * Women of child-bearing potential include any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea >= 12 consecutive months; or women on hormone replacement therapy [HRT] with documented serum follicle stimulating hormone [FSH] level > 35 mIU/mL); even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (or Karnofsky performance status [KPS] >= 80)\n* Absolute neutrophil count (ANC) >= 1,500/uL\n* Platelet count >= 100,000/uL\n* Calculated or measured creatinine clearance >= 50 mL/minute\n* Bilirubin =< 1.25 times upper limits of normal; for patients with Gilbert's disease, =< 2.5 x upper limit of normal (ULN) is allowed\n* Aspartate aminotransferase (AST) =< 2.0 x upper limits of normal\n* Urine protein to creatinine ratio < 1.0 or urine protein =< 1+ or 24-hour urine protein =< 1 gram\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients must have histologically or cytologically documented metastatic or unresectable transitional cell (urothelial) carcinoma of the urinary tract (renal pelvis, ureter, bladder, prostate, or urethra), with metastatic or locally advanced disease (T4b, N2, N3, or M1); patients must not be candidates for potentially curative surgery or radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "histologically or cytologically documented metastatic or unresectable transitional cell (urothelial) carcinoma of the urinary tract",
                    "criterion": "transitional cell (urothelial) carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        },
                        {
                            "requirement_type": "metastatic",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "resectability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic or locally advanced disease (T4b, N2, N3, or M1)",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "T4b",
                                "N2",
                                "N3",
                                "M1"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "patients must not be candidates for potentially curative surgery or radiotherapy",
                    "criterion": "candidacy for curative surgery or radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "candidacy",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For patients that have had surgical resection prior to study enrollment, residual or unresected disease (measurable and/or unmeasurable) must be evident on post-surgical scans",
            "criterions": [
                {
                    "exact_snippets": "patients that have had surgical resection prior to study enrollment",
                    "criterion": "surgical resection",
                    "requirements": [
                        {
                            "requirement_type": "prior occurrence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "residual or unresected disease ... must be evident on post-surgical scans",
                    "criterion": "residual or unresected disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "measurable and/or unmeasurable",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "measurable",
                                "unmeasurable"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment for transitional cell carcinoma (TCC)",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment for transitional cell carcinoma (TCC)",
                    "criterion": "prior treatment for transitional cell carcinoma (TCC)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients may not have received combination systemic chemotherapy for metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "Patients may not have received combination systemic chemotherapy for metastatic disease",
                    "criterion": "combination systemic chemotherapy for metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For the purposes of this study, radiosensitizing single agent chemotherapy is not considered prior systemic therapy",
            "criterions": [
                {
                    "exact_snippets": "radiosensitizing single agent chemotherapy is not considered prior systemic therapy",
                    "criterion": "radiosensitizing single agent chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "consideration as prior systemic therapy",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior neoadjuvant or adjuvant systemic chemotherapy is permissible provided the interval from end of therapy to diagnosis of metastatic disease is at least 1 year",
            "criterions": [
                {
                    "exact_snippets": "Prior neoadjuvant or adjuvant systemic chemotherapy is permissible",
                    "criterion": "prior neoadjuvant or adjuvant systemic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "permissibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "interval from end of therapy to diagnosis of metastatic disease is at least 1 year",
                    "criterion": "interval from end of therapy to diagnosis of metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* >= 4 weeks since any prior radiation (including palliative) or major surgery and fully recovered",
            "criterions": [
                {
                    "exact_snippets": "... >= 4 weeks since any prior radiation (including palliative) ...",
                    "criterion": "time since prior radiation",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "... >= 4 weeks since any prior ... major surgery ...",
                    "criterion": "time since major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "... fully recovered",
                    "criterion": "recovery status",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* >= 7 days since any minor surgery such as port placement",
            "criterions": [
                {
                    "exact_snippets": "... >= 7 days since any minor surgery ...",
                    "criterion": "time since minor surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* >= 4 weeks since any intravesical therapy",
            "criterions": [
                {
                    "exact_snippets": "... >= 4 weeks since any intravesical therapy",
                    "criterion": "time since intravesical therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior treatment with bevacizumab or other angiogenesis inhibitors",
            "criterions": [
                {
                    "exact_snippets": "No prior treatment with bevacizumab",
                    "criterion": "prior treatment with bevacizumab",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior treatment with ... other angiogenesis inhibitors",
                    "criterion": "prior treatment with angiogenesis inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No known history of brain metastases; brain imaging (magnetic resonance imaging [MRI]/computed tomography [CT]) is not required",
            "criterions": [
                {
                    "exact_snippets": "No known history of brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No current congestive heart failure; New York Heart Association (NYHA) class II, III or IV",
            "criterions": [
                {
                    "exact_snippets": "No current congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "New York Heart Association (NYHA) class II, III or IV",
                    "criterion": "NYHA class",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": [
                                "II",
                                "III",
                                "IV"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with history of hypertension must be well controlled (< 150/90) on a regimen of anti-hypertensive therapy",
            "criterions": [
                {
                    "exact_snippets": "history of hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must be well controlled (< 150/90)",
                    "criterion": "blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "measurement",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 150,
                                        "unit": "mmHg"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 90,
                                        "unit": "mmHg"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "on a regimen of anti-hypertensive therapy",
                    "criterion": "anti-hypertensive therapy",
                    "requirements": [
                        {
                            "requirement_type": "regimen",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients on full-dose anticoagulants must be on a stable dose of warfarin and have an in-range international normalized ratio (INR) (usually between 2 and 3) or be on a stable dose of low molecular weight (LMW) heparin; patients receiving anti-platelet agents are also eligible; in addition, patients who are on daily prophylactic aspirin or anticoagulation for atrial fibrillation are eligible",
            "criterions": [
                {
                    "exact_snippets": "Patients on full-dose anticoagulants must be on a stable dose of warfarin",
                    "criterion": "full-dose anticoagulants",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "stable dose of warfarin"
                        }
                    ]
                },
                {
                    "exact_snippets": "in-range international normalized ratio (INR) (usually between 2 and 3)",
                    "criterion": "international normalized ratio (INR)",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "stable dose of low molecular weight (LMW) heparin",
                    "criterion": "low molecular weight (LMW) heparin",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "stable dose"
                        }
                    ]
                },
                {
                    "exact_snippets": "patients receiving anti-platelet agents are also eligible",
                    "criterion": "anti-platelet agents",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients who are on daily prophylactic aspirin",
                    "criterion": "daily prophylactic aspirin",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "anticoagulation for atrial fibrillation",
                    "criterion": "anticoagulation for atrial fibrillation",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No significant history of bleeding events or gastrointestinal (GI) perforation",
            "criterions": [
                {
                    "exact_snippets": "No significant history of bleeding events",
                    "criterion": "history of bleeding events",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "No significant history of ... gastrointestinal (GI) perforation",
                    "criterion": "history of gastrointestinal (GI) perforation",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a history of a significant bleeding episode (e.g. hemoptysis, upper or lower GI bleeding, grade 3 or 4 gross hematuria unable to be controlled by trans-urethral resection of the bladder tumor) within 6 months of registration are not eligible",
            "criterions": [
                {
                    "exact_snippets": "history of a significant bleeding episode",
                    "criterion": "significant bleeding episode",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hemoptysis",
                    "criterion": "hemoptysis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "upper or lower GI bleeding",
                    "criterion": "upper or lower GI bleeding",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "grade 3 or 4 gross hematuria unable to be controlled by trans-urethral resection of the bladder tumor",
                    "criterion": "grade 3 or 4 gross hematuria",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "grade 3",
                                "grade 4"
                            ]
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "within 6 months of registration",
                    "criterion": "time since bleeding episode",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a history of GI perforation within 12 months of registration are not eligible",
            "criterions": [
                {
                    "exact_snippets": "history of GI perforation within 12 months of registration",
                    "criterion": "GI perforation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 12,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a history of peritoneal carcinomatosis are not eligible",
            "criterions": [
                {
                    "exact_snippets": "history of peritoneal carcinomatosis",
                    "criterion": "peritoneal carcinomatosis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No arterial thrombotic events within 6 months of registration, including transient ischemic attack (TIA), cerebrovascular accident (CVA), peripheral arterial thrombus, unstable angina or angina requiring surgical or medical intervention in the past 6 months, or myocardial infarction (MI); patients with clinically significant peripheral artery disease (i.e., claudication on less than one block) are ineligible",
            "criterions": [
                {
                    "exact_snippets": "No arterial thrombotic events within 6 months of registration",
                    "criterion": "arterial thrombotic events",
                    "requirements": [
                        {
                            "requirement_type": "time since last event",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "transient ischemic attack (TIA)",
                    "criterion": "transient ischemic attack (TIA)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "cerebrovascular accident (CVA)",
                    "criterion": "cerebrovascular accident (CVA)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "peripheral arterial thrombus",
                    "criterion": "peripheral arterial thrombus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "angina requiring surgical or medical intervention in the past 6 months",
                    "criterion": "angina requiring surgical or medical intervention",
                    "requirements": [
                        {
                            "requirement_type": "time since last intervention",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction (MI)",
                    "criterion": "myocardial infarction (MI)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant peripheral artery disease (i.e., claudication on less than one block)",
                    "criterion": "clinically significant peripheral artery disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "claudication on less than one block"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have experienced a deep venous thrombosis or pulmonary embolus within the past 6 months must be on stable therapeutic anticoagulation to be enrolled to this study",
            "criterions": [
                {
                    "exact_snippets": "Patients who have experienced a deep venous thrombosis",
                    "criterion": "deep venous thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who have experienced a ... pulmonary embolus",
                    "criterion": "pulmonary embolus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within the past 6 months",
                    "criterion": "time since event",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "must be on stable therapeutic anticoagulation",
                    "criterion": "therapeutic anticoagulation",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No serious or non-healing wound, ulcer, or bone fracture",
            "criterions": [
                {
                    "exact_snippets": "serious or non-healing wound",
                    "criterion": "wound",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not serious"
                        },
                        {
                            "requirement_type": "healing status",
                            "expected_value": "healing"
                        }
                    ]
                },
                {
                    "exact_snippets": "ulcer",
                    "criterion": "ulcer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "bone fracture",
                    "criterion": "bone fracture",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No sensory or motor peripheral neuropathy >= grade 2",
            "criterions": [
                {
                    "exact_snippets": "No sensory or motor peripheral neuropathy >= grade 2",
                    "criterion": "sensory or motor peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies are not eligible",
            "criterions": [
                {
                    "exact_snippets": "known hypersensitivity to Chinese hamster ovary cell products",
                    "criterion": "hypersensitivity to Chinese hamster ovary cell products",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "known hypersensitivity to ... recombinant human antibodies",
                    "criterion": "hypersensitivity to recombinant human antibodies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients that are pregnant or nursing are not eligible; women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours prior to registration",
            "criterions": [
                {
                    "exact_snippets": "Patients that are pregnant ... are not eligible",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "nursing",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "women of child bearing potential ... must have a negative serum or urine pregnancy test",
                    "criterion": "pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]",
                    "criterion": "pregnancy test sensitivity",
                    "requirements": [
                        {
                            "requirement_type": "sensitivity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 25,
                                "unit": "IU/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "within 72 hours prior to registration",
                    "criterion": "pregnancy test timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 72,
                                "unit": "hours"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For women of child-bearing potential with an elevated beta-HCG that is believed to be related to cancer and not pregnancy, a negative trans-vaginal ultrasound and gynecological examination are required",
            "criterions": [
                {
                    "exact_snippets": "women of child-bearing potential",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive status",
                            "expected_value": "child-bearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "elevated beta-HCG ... related to cancer and not pregnancy",
                    "criterion": "beta-HCG level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "elevated"
                        },
                        {
                            "requirement_type": "cause",
                            "expected_value": "related to cancer and not pregnancy"
                        }
                    ]
                },
                {
                    "exact_snippets": "negative trans-vaginal ultrasound",
                    "criterion": "trans-vaginal ultrasound result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "negative ... gynecological examination",
                    "criterion": "gynecological examination result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of child-bearing potential include any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea >= 12 consecutive months; or women on hormone replacement therapy [HRT] with documented serum follicle stimulating hormone [FSH] level > 35 mIU/mL); even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential",
            "criterions": [
                {
                    "exact_snippets": "Women of child-bearing potential include any female who has experienced menarche",
                    "criterion": "menarche",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy)",
                    "criterion": "surgical sterilization",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "is not postmenopausal [defined as amenorrhea >= 12 consecutive months",
                    "criterion": "postmenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "amenorrhea duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "women on hormone replacement therapy [HRT] with documented serum follicle stimulating hormone [FSH] level > 35 mIU/mL",
                    "criterion": "FSH level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 35,
                                "unit": "mIU/mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy",
                    "criterion": "contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "practicing abstinence",
                    "criterion": "abstinence",
                    "requirements": [
                        {
                            "requirement_type": "practice",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "partner is sterile (e.g., vasectomy)",
                    "criterion": "partner sterility",
                    "requirements": [
                        {
                            "requirement_type": "sterility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (or Karnofsky performance status [KPS] >= 80)",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Karnofsky performance status [KPS] >= 80",
                    "criterion": "Karnofsky performance status",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 80,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count (ANC) >= 1,500/uL",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) >= 1,500/uL",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "uL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count >= 100,000/uL",
            "criterions": [
                {
                    "exact_snippets": "Platelet count >= 100,000/uL",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "uL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Calculated or measured creatinine clearance >= 50 mL/minute",
            "criterions": [
                {
                    "exact_snippets": "creatinine clearance >= 50 mL/minute",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "mL/minute"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin =< 1.25 times upper limits of normal; for patients with Gilbert's disease, =< 2.5 x upper limit of normal (ULN) is allowed",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin =< 1.25 times upper limits of normal",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.25,
                                "unit": "times upper limits of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "for patients with Gilbert's disease, =< 2.5 x upper limit of normal (ULN) is allowed",
                    "criterion": "bilirubin level for patients with Gilbert's disease",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x upper limit of normal (ULN)"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Aspartate aminotransferase (AST) =< 2.0 x upper limits of normal",
            "criterions": [
                {
                    "exact_snippets": "Aspartate aminotransferase (AST) =< 2.0 x upper limits of normal",
                    "criterion": "Aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "x upper limits of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Urine protein to creatinine ratio < 1.0 or urine protein =< 1+ or 24-hour urine protein =< 1 gram",
            "criterions": [
                {
                    "exact_snippets": "Urine protein to creatinine ratio < 1.0",
                    "criterion": "urine protein to creatinine ratio",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.0,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "urine protein =< 1+",
                    "criterion": "urine protein",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "+"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "24-hour urine protein =< 1 gram",
                    "criterion": "24-hour urine protein",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "gram"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}