{
    "info": {
        "nct_id": "NCT00022191",
        "official_title": "Randomized Phase III Study Comparing Paclitaxel/Cisplatin/Gemcitabine and Cisplatin/Gemcitabine in Patients With Metastatic or Locally Advanced Urothelial Cancer Without Prior Systemic Therapy",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed stage IV transitional cell carcinoma of the urothelium (pure or mixed) including bladder, urethra, ureter, and renal pelvis\n\n  * T4b, any N OR any T, N2-3 OR M1\n* Ineligible for surgery or radiotherapy with curative intent\n* Measurable or evaluable disease\n* No known CNS metastases\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* WHO 0-1\n\nLife expectancy:\n\n* At least 12 weeks\n\nHematopoietic:\n\n* WBC at least 3,000/mm^3\n* Platelet count at least 100,000/mm^3\n* Hemoglobin at least 10 g/dL\n\nHepatic:\n\n* Bilirubin less than 1.25 times normal\n* AST or ALT less than 2.5 times normal\n\nRenal:\n\n* Glomerular filtration rate at least 60 mL/min\n* Calcium normal or clinically insignificant\n\nCardiovascular:\n\n* No clinically significant cardiac arrhythmia\n* No congestive heart failure\n* No complete bundle branch block\n* No New York Heart Association class III or IV heart disease\n\nOther:\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 6 months after study participation\n* No psychological, familial, sociological, or geographical condition that would preclude study compliance\n* No grade 3 or 4 infection without neutropenia\n* No other serious concurrent systemic disorder that would preclude study therapy\n* No mental disorder that would preclude study compliance\n* No grade II or greater neuropathy\n* No other prior or concurrent malignancy except appropriately treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, or incidental prostate cancer (T1, Gleason score no greater than 6, and PSA less than 0.5 ng/mL)\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No prior investigational biologic agents (e.g., antiangiogenic products, signal transduction pathway inhibitors, immunomodulators, or monoclonal antibody therapy)\n* At least 4 weeks since prior immunotherapy\n\nChemotherapy:\n\n* No prior systemic chemotherapy\n* At least 4 weeks since prior local intravesical chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* See Disease Characteristics\n* No more than 1 prior course of radiotherapy\n* At least 4 weeks since prior radiotherapy and recovered\n\nSurgery:\n\n* See Disease Characteristics\n* Prior urological procedures to relieve urinary tract obstruction and improve renal function allowed (e.g., ureteral stent or percutaneous nephrostomy)"
    },
    "inclusion_lines": [
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "DISEASE CHARACTERISTICS:",
            "criterions": [
                {
                    "exact_snippets": "DISEASE CHARACTERISTICS",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically confirmed stage IV transitional cell carcinoma of the urothelium (pure or mixed) including bladder, urethra, ureter, and renal pelvis",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed stage IV transitional cell carcinoma of the urothelium",
                    "criterion": "transitional cell carcinoma of the urothelium",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        }
                    ]
                },
                {
                    "exact_snippets": "bladder, urethra, ureter, and renal pelvis",
                    "criterion": "location of carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "bladder",
                                "urethra",
                                "ureter",
                                "renal pelvis"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* T4b, any N OR any T, N2-3 OR M1",
            "criterions": [
                {
                    "exact_snippets": "T4b",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "T4b"
                        }
                    ]
                },
                {
                    "exact_snippets": "any N",
                    "criterion": "lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "any N"
                        }
                    ]
                },
                {
                    "exact_snippets": "any T",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "any T"
                        }
                    ]
                },
                {
                    "exact_snippets": "N2-3",
                    "criterion": "lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "N2-3"
                        }
                    ]
                },
                {
                    "exact_snippets": "M1",
                    "criterion": "metastasis",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "M1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ineligible for surgery or radiotherapy with curative intent",
            "criterions": [
                {
                    "exact_snippets": "Ineligible for surgery",
                    "criterion": "surgery eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Ineligible for ... radiotherapy with curative intent",
                    "criterion": "radiotherapy eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable or evaluable disease",
            "criterions": [
                {
                    "exact_snippets": "Measurable or evaluable disease",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "evaluable"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No known CNS metastases",
            "criterions": [
                {
                    "exact_snippets": "No known CNS metastases",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Age:",
            "criterions": [
                {
                    "exact_snippets": "Age:",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 18 and over",
            "criterions": [
                {
                    "exact_snippets": "18 and over",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Performance status:",
            "criterions": [
                {
                    "exact_snippets": "Performance status:",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WHO 0-1",
            "criterions": [
                {
                    "exact_snippets": "WHO 0-1",
                    "criterion": "WHO performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Life expectancy:",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 12 weeks",
            "criterions": [
                {
                    "exact_snippets": "At least 12 weeks",
                    "criterion": "duration",
                    "requirements": [
                        {
                            "requirement_type": "minimum duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hematopoietic:",
            "criterions": [
                {
                    "exact_snippets": "Hematopoietic:",
                    "criterion": "hematopoietic system",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WBC at least 3,000/mm^3",
            "criterions": [
                {
                    "exact_snippets": "WBC at least 3,000/mm^3",
                    "criterion": "WBC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count at least 100,000/mm^3",
            "criterions": [
                {
                    "exact_snippets": "Platelet count at least 100,000/mm^3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin at least 10 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin at least 10 g/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hepatic:",
            "criterions": [
                {
                    "exact_snippets": "Hepatic",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin less than 1.25 times normal",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin less than 1.25 times normal",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.25,
                                "unit": "times normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST or ALT less than 2.5 times normal",
            "criterions": [
                {
                    "exact_snippets": "AST or ALT less than 2.5 times normal",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "times normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST or ALT less than 2.5 times normal",
                    "criterion": "ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "times normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Renal:",
            "criterions": [
                {
                    "exact_snippets": "Renal:",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Glomerular filtration rate at least 60 mL/min",
            "criterions": [
                {
                    "exact_snippets": "Glomerular filtration rate at least 60 mL/min",
                    "criterion": "glomerular filtration rate",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Calcium normal or clinically insignificant",
            "criterions": [
                {
                    "exact_snippets": "Calcium normal or clinically insignificant",
                    "criterion": "calcium level",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "normal",
                                "clinically insignificant"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Cardiovascular:",
            "criterions": [
                {
                    "exact_snippets": "Cardiovascular:",
                    "criterion": "cardiovascular condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No clinically significant cardiac arrhythmia",
            "criterions": [
                {
                    "exact_snippets": "clinically significant cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No congestive heart failure",
            "criterions": [
                {
                    "exact_snippets": "No congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No complete bundle branch block",
            "criterions": [
                {
                    "exact_snippets": "No complete bundle branch block",
                    "criterion": "complete bundle branch block",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No New York Heart Association class III or IV heart disease",
            "criterions": [
                {
                    "exact_snippets": "No New York Heart Association class III or IV heart disease",
                    "criterion": "New York Heart Association heart disease class",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "!=",
                                "value": 3,
                                "unit": "class"
                            }
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "!=",
                                "value": 4,
                                "unit": "class"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Negative pregnancy test",
            "criterions": [
                {
                    "exact_snippets": "Negative pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fertile patients must use effective contraception during and for 6 months after study participation",
            "criterions": [
                {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    ]
                },
                {
                    "exact_snippets": "must use effective contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "during and for 6 months after study participation",
                    "criterion": "contraception duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during and for 6 months after study participation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No psychological, familial, sociological, or geographical condition that would preclude study compliance",
            "criterions": [
                {
                    "exact_snippets": "No psychological ... condition that would preclude study compliance",
                    "criterion": "psychological condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... familial ... condition that would preclude study compliance",
                    "criterion": "familial condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... sociological ... condition that would preclude study compliance",
                    "criterion": "sociological condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... geographical condition that would preclude study compliance",
                    "criterion": "geographical condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No grade 3 or 4 infection without neutropenia",
            "criterions": [
                {
                    "exact_snippets": "No grade 3 or 4 infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "without neutropenia",
                    "criterion": "neutropenia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other serious concurrent systemic disorder that would preclude study therapy",
            "criterions": [
                {
                    "exact_snippets": "No other serious concurrent systemic disorder",
                    "criterion": "serious concurrent systemic disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No mental disorder that would preclude study compliance",
            "criterions": [
                {
                    "exact_snippets": "No mental disorder that would preclude study compliance",
                    "criterion": "mental disorder",
                    "requirements": [
                        {
                            "requirement_type": "impact on study compliance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No grade II or greater neuropathy",
            "criterions": [
                {
                    "exact_snippets": "No grade II or greater neuropathy",
                    "criterion": "neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other prior or concurrent malignancy except appropriately treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, or incidental prostate cancer (T1, Gleason score no greater than 6, and PSA less than 0.5 ng/mL)",
            "criterions": [
                {
                    "exact_snippets": "No other prior or concurrent malignancy",
                    "criterion": "prior or concurrent malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "appropriately treated carcinoma in situ of the cervix",
                    "criterion": "carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "appropriately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "basal cell carcinoma of the skin",
                    "criterion": "basal cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "incidental prostate cancer (T1, Gleason score no greater than 6, and PSA less than 0.5 ng/mL)",
                    "criterion": "incidental prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "T1"
                        },
                        {
                            "requirement_type": "Gleason score",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "PSA",
                            "expected_value": {
                                "operator": "<",
                                "value": 0.5,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY:",
            "criterions": [
                {
                    "exact_snippets": "PRIOR CONCURRENT THERAPY",
                    "criterion": "prior concurrent therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Biologic therapy:",
            "criterions": [
                {
                    "exact_snippets": "Biologic therapy",
                    "criterion": "biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior investigational biologic agents (e.g., antiangiogenic products, signal transduction pathway inhibitors, immunomodulators, or monoclonal antibody therapy)",
            "criterions": [
                {
                    "exact_snippets": "No prior investigational biologic agents",
                    "criterion": "prior investigational biologic agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "antiangiogenic products",
                    "criterion": "prior antiangiogenic products",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "signal transduction pathway inhibitors",
                    "criterion": "prior signal transduction pathway inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "immunomodulators",
                    "criterion": "prior immunomodulators",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "monoclonal antibody therapy",
                    "criterion": "prior monoclonal antibody therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 4 weeks since prior immunotherapy",
            "criterions": [
                {
                    "exact_snippets": "At least 4 weeks since prior immunotherapy",
                    "criterion": "time since prior immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Chemotherapy:",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior systemic chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "No prior systemic chemotherapy",
                    "criterion": "prior systemic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Endocrine therapy:",
            "criterions": [
                {
                    "exact_snippets": "Endocrine therapy",
                    "criterion": "endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Radiotherapy:",
            "criterions": [
                {
                    "exact_snippets": "Radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* See Disease Characteristics",
            "criterions": [
                {
                    "exact_snippets": "Disease Characteristics",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "See Disease Characteristics"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No more than 1 prior course of radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "No more than 1 prior course of radiotherapy",
                    "criterion": "prior course of radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 4 weeks since prior radiotherapy and recovered",
            "criterions": [
                {
                    "exact_snippets": "At least 4 weeks since prior radiotherapy",
                    "criterion": "time since prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "recovered",
                    "criterion": "recovery from prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "recovered"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Surgery:",
            "criterions": [
                {
                    "exact_snippets": "Surgery",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* See Disease Characteristics",
            "criterions": [
                {
                    "exact_snippets": "Disease Characteristics",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "See Disease Characteristics"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior urological procedures to relieve urinary tract obstruction and improve renal function allowed (e.g., ureteral stent or percutaneous nephrostomy)",
            "criterions": [
                {
                    "exact_snippets": "Prior urological procedures to relieve urinary tract obstruction and improve renal function allowed",
                    "criterion": "prior urological procedures",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "Other:",
            "criterions": []
        },
        {
            "line": "* Not pregnant or nursing",
            "criterions": [
                {
                    "exact_snippets": "Not pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not ... nursing",
                    "criterion": "nursing status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 4 weeks since prior local intravesical chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "at least 4 weeks since prior local intravesical chemotherapy",
                    "criterion": "time since prior local intravesical chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Not specified",
            "criterions": []
        }
    ]
}