{
    "info": {
        "nct_id": "NCT01575548",
        "official_title": "Randomized, Double-Blind Phase III Study of Pazopanib vs. Placebo in Patients With Metastatic Renal Cell Carcinoma Who Have No Evidence of Disease Following Metastatectomy",
        "inclusion_criteria": "* Patient must be at least 18 years of age at the time of randomization\n* Patient must have pathologically confirmed renal cell carcinoma with a clear cell component; pure papillary and chromophobe histologies are excluded; there must be pathologic confirmation of metastatic disease in the resected metastasectomy specimen\n* Patient must have undergone nephrectomy or partial nephrectomy to remove primary renal cell carcinoma (at any time in the past)\n* Patient must have undergone surgical resection to remove one or more sites of metastatic disease, with successful removal of all known sites 2-12 weeks prior to randomization. Any number of prior metastasectomies may have been performed in the past, so long as the most recent procedure was within the 12 weeks of registration. The most recent procedure may be nephrectomy for a renal primary tumor\n* Patients with synchronous disease at initial diagnosis must have metastatic (M1) disease (American Joint Committee on Cancer [AJCC] 7th edition T1-4N0-1M1)\n* Positive surgical margins are permitted if the surgeon confirms complete resection of gross metastatic disease, and post-operative scans are negative\n* Patients presenting with metachronous disease may have distant metastases, regional lymph node or renal bed recurrence. Recurrences at a partial nephrectomy resection site are not eligible if it is the only site of disease\n* Patient must have no evidence of disease on post-operative imaging:\n\n  * A computed tomography (CT) of the chest must be obtained within 4 weeks prior to randomization with or without contrast\n  * A CT of the abdomen/pelvis must be obtained within 4 weeks prior to randomization with intravenous (IV) contrast (oral contrast may be added at the radiologist's discretion); an magnetic resonance imaging (MRI) of the abdomen/pelvis with gadolinium may be substituted for the CT if the CT with IV contrast is contra-indicated\n  * An MRI of the brain with and without gadolinium must be done within 8 weeks prior to randomization; a CT of the brain with and without IV contrast is permitted if MRI is contra-indicated (i.e., pacemaker)\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the time of randomization\n* Absolute granulocyte count > 1,500/mcL (within 2 weeks prior to randomization)\n* Platelets > 100,000/mcL (within 2 weeks prior to randomization)\n* Total bilirubin < 1.5 x institutional upper limit of normal (ULN) (within 2 weeks prior to randomization)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 x upper limit of normal (ULN) (within 2 weeks prior to randomization)\n* Calculated creatinine clearance (CrCl) > 30 mL/min (within 2 weeks prior to randomization)\n* Subjects must have a urine protein/creatinine (UPC) ratio < 1; if UPC >= 1, then a 24-hour urine total protein must be obtained; subjects must have a 24-hour urine protein value < 1 g to be eligible; use of urine dipstick for renal function assessment is not acceptable (within 2 weeks prior to randomization)\n* All females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study; should a woman become pregnant while participating in this study, she should inform her treating physician immediately; if a man impregnates a woman while participating in this study, he should inform his treating physician immediately\n* Patient must be able to swallow pills and have no significant impairment in gastrointestinal absorption including history of gastric bypass surgery\n* Patient must have a corrected QT (QTc) interval on electrocardiogram (ECG) =< 0.48 seconds by Bazett's calculation (=< Common Terminology Criteria for Adverse Events [CTCAE] version [v.]4 grade 2) prior to randomization\n* Patient must have a systolic blood pressure =< 140 mmHg and diastolic blood pressure must be =< 90 mmHg, measured within 4 weeks prior to randomization; initiation or adjustment of anti-hypertensives prior to starting study treatment is allowed\n* Patient must have no history of cerebrovascular accident (CVA) within 6 months of randomization\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients presenting with tumors within the kidneys (multiple synchronous or single/multiple metachronous) are not eligible if there are no extrarenal sites of disease (i.e. potential multifocal primary disease)\n* Patient must not have received any prior or concurrent systemic therapy for RCC. Adjuvant placebo administration is permitted\n* Patient must have no active peptic ulcer disease\n* Patient must have no active inflammatory bowel disease\n* Patient must have no New York Heart Association (NYHA) class II or greater congestive heart failure\n* Patient must have no prior history or current clinically apparent central nervous system metastases\n* Women must not be pregnant or breast-feeding due to the unknown effects of pazopanib on the developing fetus\n* Patient must have no history of allergic reactions attributed to compounds of similar chemical or biologic composition to pazopanib\n* Patient must have no uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\n* Patient must not have serious or non-healing wound, ulcer, or bone fracture at the time of randomization\n* Patient must have no history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to randomization\n* Patient must have no history of myocardial infarction, hospital admission for unstable angina, cardiac angioplasty or stenting within 6 months of randomization\n* Patient must have no history venous thrombosis within 12 weeks of randomization\n* Patient cannot be taking strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors such as:\n\n  * Antibiotics: clarithromycin, telithromycin, troleandomycin\n  * Human immunodeficiency virus (HIV) antiviral protease inhibitors: ritonavir, indinavir, saquinavir, nelfinavir, amprenavir, lopinavir\n  * Antifungals: itraconazole, ketoconazole, voriconazole, fluconazole\n  * Antidepressants: nefazodone\n* Patient must not have history of hemoptysis in excess of 2.5 mL (1/2 teaspoon) within 8 weeks prior to randomization\n* Patient must not be taking drugs known to prolong the QTc interval; such drugs should be discontinued at least 5 half-lives prior to randomization\n* Patients must not have any history of other cancer within 3 years from time of randomization with the exception of basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or resected non-invasive (Ta) urothelial carcinoma",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patient must be at least 18 years of age at the time of randomization",
            "criterions": [
                {
                    "exact_snippets": "Patient must be at least 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must have pathologically confirmed renal cell carcinoma with a clear cell component; pure papillary and chromophobe histologies are excluded; there must be pathologic confirmation of metastatic disease in the resected metastasectomy specimen",
            "criterions": [
                {
                    "exact_snippets": "pathologically confirmed renal cell carcinoma",
                    "criterion": "renal cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clear cell component",
                    "criterion": "clear cell component",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pure papillary and chromophobe histologies are excluded",
                    "criterion": "pure papillary and chromophobe histologies",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pathologic confirmation of metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "resected metastasectomy specimen",
                    "criterion": "resected metastasectomy specimen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must have undergone nephrectomy or partial nephrectomy to remove primary renal cell carcinoma (at any time in the past)",
            "criterions": [
                {
                    "exact_snippets": "undergone nephrectomy or partial nephrectomy to remove primary renal cell carcinoma",
                    "criterion": "nephrectomy",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "undergone nephrectomy or partial nephrectomy to remove primary renal cell carcinoma",
                    "criterion": "partial nephrectomy",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must have undergone surgical resection to remove one or more sites of metastatic disease, with successful removal of all known sites 2-12 weeks prior to randomization. Any number of prior metastasectomies may have been performed in the past, so long as the most recent procedure was within the 12 weeks of registration. The most recent procedure may be nephrectomy for a renal primary tumor",
            "criterions": [
                {
                    "exact_snippets": "undergone surgical resection to remove one or more sites of metastatic disease",
                    "criterion": "surgical resection of metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "successful removal of all known sites",
                    "criterion": "removal of all known metastatic sites",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "2-12 weeks prior to randomization",
                    "criterion": "time since surgical resection",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "weeks"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 12,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Any number of prior metastasectomies may have been performed",
                    "criterion": "number of prior metastasectomies",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "any number"
                        }
                    ]
                },
                {
                    "exact_snippets": "most recent procedure was within the 12 weeks of registration",
                    "criterion": "time since most recent metastasectomy",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 12,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "most recent procedure may be nephrectomy for a renal primary tumor",
                    "criterion": "type of most recent procedure",
                    "requirements": [
                        {
                            "requirement_type": "procedure type",
                            "expected_value": [
                                "nephrectomy",
                                "metastasectomy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with synchronous disease at initial diagnosis must have metastatic (M1) disease (American Joint Committee on Cancer [AJCC] 7th edition T1-4N0-1M1)",
            "criterions": [
                {
                    "exact_snippets": "synchronous disease at initial diagnosis",
                    "criterion": "synchronous disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic (M1) disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "M1"
                        }
                    ]
                },
                {
                    "exact_snippets": "American Joint Committee on Cancer [AJCC] 7th edition T1-4N0-1M1",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": "AJCC 7th edition T1-4N0-1M1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Positive surgical margins are permitted if the surgeon confirms complete resection of gross metastatic disease, and post-operative scans are negative",
            "criterions": [
                {
                    "exact_snippets": "Positive surgical margins are permitted",
                    "criterion": "surgical margins",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "surgeon confirms complete resection of gross metastatic disease",
                    "criterion": "resection of gross metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "completeness",
                            "expected_value": "complete"
                        }
                    ]
                },
                {
                    "exact_snippets": "post-operative scans are negative",
                    "criterion": "post-operative scans",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients presenting with metachronous disease may have distant metastases, regional lymph node or renal bed recurrence. Recurrences at a partial nephrectomy resection site are not eligible if it is the only site of disease",
            "criterions": [
                {
                    "exact_snippets": "Patients presenting with metachronous disease",
                    "criterion": "metachronous disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "distant metastases",
                    "criterion": "distant metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "regional lymph node",
                    "criterion": "regional lymph node recurrence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "renal bed recurrence",
                    "criterion": "renal bed recurrence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Recurrences at a partial nephrectomy resection site are not eligible if it is the only site of disease",
                    "criterion": "recurrence at partial nephrectomy resection site",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must have no evidence of disease on post-operative imaging:",
            "criterions": [
                {
                    "exact_snippets": "no evidence of disease on post-operative imaging",
                    "criterion": "evidence of disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A computed tomography (CT) of the chest must be obtained within 4 weeks prior to randomization with or without contrast",
            "criterions": [
                {
                    "exact_snippets": "A computed tomography (CT) of the chest must be obtained within 4 weeks prior to randomization",
                    "criterion": "computed tomography (CT) of the chest",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 4 weeks prior to randomization"
                        }
                    ]
                },
                {
                    "exact_snippets": "with or without contrast",
                    "criterion": "contrast in CT scan",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "with",
                                "without"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A CT of the abdomen/pelvis must be obtained within 4 weeks prior to randomization with intravenous (IV) contrast (oral contrast may be added at the radiologist's discretion); an magnetic resonance imaging (MRI) of the abdomen/pelvis with gadolinium may be substituted for the CT if the CT with IV contrast is contra-indicated",
            "criterions": [
                {
                    "exact_snippets": "A CT of the abdomen/pelvis must be obtained within 4 weeks prior to randomization",
                    "criterion": "CT of the abdomen/pelvis",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 4 weeks prior to randomization"
                        }
                    ]
                },
                {
                    "exact_snippets": "with intravenous (IV) contrast",
                    "criterion": "CT of the abdomen/pelvis",
                    "requirements": [
                        {
                            "requirement_type": "contrast type",
                            "expected_value": "intravenous (IV)"
                        }
                    ]
                },
                {
                    "exact_snippets": "an magnetic resonance imaging (MRI) of the abdomen/pelvis with gadolinium may be substituted for the CT if the CT with IV contrast is contra-indicated",
                    "criterion": "MRI of the abdomen/pelvis",
                    "requirements": [
                        {
                            "requirement_type": "contrast type",
                            "expected_value": "gadolinium"
                        },
                        {
                            "requirement_type": "substitution condition",
                            "expected_value": "if the CT with IV contrast is contra-indicated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* An MRI of the brain with and without gadolinium must be done within 8 weeks prior to randomization; a CT of the brain with and without IV contrast is permitted if MRI is contra-indicated (i.e., pacemaker)",
            "criterions": [
                {
                    "exact_snippets": "MRI of the brain with and without gadolinium must be done within 8 weeks prior to randomization",
                    "criterion": "MRI of the brain",
                    "requirements": [
                        {
                            "requirement_type": "contrast",
                            "expected_value": [
                                "with gadolinium",
                                "without gadolinium"
                            ]
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 8 weeks prior to randomization"
                        }
                    ]
                },
                {
                    "exact_snippets": "CT of the brain with and without IV contrast is permitted if MRI is contra-indicated",
                    "criterion": "CT of the brain",
                    "requirements": [
                        {
                            "requirement_type": "contrast",
                            "expected_value": [
                                "with IV contrast",
                                "without IV contrast"
                            ]
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "if MRI is contra-indicated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the time of randomization",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute granulocyte count > 1,500/mcL (within 2 weeks prior to randomization)",
            "criterions": [
                {
                    "exact_snippets": "Absolute granulocyte count > 1,500/mcL",
                    "criterion": "absolute granulocyte count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1500,
                                "unit": "mcL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelets > 100,000/mcL (within 2 weeks prior to randomization)",
            "criterions": [
                {
                    "exact_snippets": "Platelets > 100,000/mcL",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "mcL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin < 1.5 x institutional upper limit of normal (ULN) (within 2 weeks prior to randomization)",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin < 1.5 x institutional upper limit of normal (ULN)",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x institutional ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 x upper limit of normal (ULN) (within 2 weeks prior to randomization)",
            "criterions": [
                {
                    "exact_snippets": "Aspartate aminotransferase (AST) ... < 2.5 x upper limit of normal (ULN)",
                    "criterion": "aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine aminotransferase (ALT) ... < 2.5 x upper limit of normal (ULN)",
                    "criterion": "alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Calculated creatinine clearance (CrCl) > 30 mL/min (within 2 weeks prior to randomization)",
            "criterions": [
                {
                    "exact_snippets": "Calculated creatinine clearance (CrCl) > 30 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects must have a urine protein/creatinine (UPC) ratio < 1; if UPC >= 1, then a 24-hour urine total protein must be obtained; subjects must have a 24-hour urine protein value < 1 g to be eligible; use of urine dipstick for renal function assessment is not acceptable (within 2 weeks prior to randomization)",
            "criterions": [
                {
                    "exact_snippets": "urine protein/creatinine (UPC) ratio < 1",
                    "criterion": "urine protein/creatinine (UPC) ratio",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "24-hour urine protein value < 1 g",
                    "criterion": "24-hour urine protein value",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "g"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "use of urine dipstick for renal function assessment is not acceptable",
                    "criterion": "use of urine dipstick for renal function assessment",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* All females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)",
            "criterions": [
                {
                    "exact_snippets": "All females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 2 weeks prior to randomization"
                        }
                    ]
                },
                {
                    "exact_snippets": "a female of childbearing potential is any woman ... who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy",
                    "criterion": "hysterectomy or bilateral oophorectomy",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "a female of childbearing potential is any woman ... who meets the following criteria: ... 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)",
                    "criterion": "postmenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 24,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study; should a woman become pregnant while participating in this study, she should inform her treating physician immediately; if a man impregnates a woman while participating in this study, he should inform his treating physician immediately",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential",
                    "criterion": "women of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sexually active males",
                    "criterion": "sexually active males",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "use an accepted and effective method of contraception",
                    "criterion": "contraception method",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": "accepted and effective"
                        }
                    ]
                },
                {
                    "exact_snippets": "abstain from sexual intercourse",
                    "criterion": "sexual intercourse",
                    "requirements": [
                        {
                            "requirement_type": "abstinence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must be able to swallow pills and have no significant impairment in gastrointestinal absorption including history of gastric bypass surgery",
            "criterions": [
                {
                    "exact_snippets": "Patient must be able to swallow pills",
                    "criterion": "ability to swallow pills",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no significant impairment in gastrointestinal absorption",
                    "criterion": "gastrointestinal absorption",
                    "requirements": [
                        {
                            "requirement_type": "impairment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of gastric bypass surgery",
                    "criterion": "gastric bypass surgery",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must have a corrected QT (QTc) interval on electrocardiogram (ECG) =< 0.48 seconds by Bazett's calculation (=< Common Terminology Criteria for Adverse Events [CTCAE] version [v.]4 grade 2) prior to randomization",
            "criterions": [
                {
                    "exact_snippets": "corrected QT (QTc) interval on electrocardiogram (ECG) =< 0.48 seconds by Bazett's calculation",
                    "criterion": "corrected QT (QTc) interval",
                    "requirements": [
                        {
                            "requirement_type": "measurement",
                            "expected_value": {
                                "operator": "<=",
                                "value": 0.48,
                                "unit": "seconds"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must have a systolic blood pressure =< 140 mmHg and diastolic blood pressure must be =< 90 mmHg, measured within 4 weeks prior to randomization; initiation or adjustment of anti-hypertensives prior to starting study treatment is allowed",
            "criterions": [
                {
                    "exact_snippets": "systolic blood pressure =< 140 mmHg",
                    "criterion": "systolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 140,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "diastolic blood pressure must be =< 90 mmHg",
                    "criterion": "diastolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 90,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "measured within 4 weeks prior to randomization",
                    "criterion": "blood pressure measurement timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 4 weeks prior to randomization"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must have no history of cerebrovascular accident (CVA) within 6 months of randomization",
            "criterions": [
                {
                    "exact_snippets": "no history of cerebrovascular accident (CVA) within 6 months of randomization",
                    "criterion": "cerebrovascular accident (CVA)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients presenting with tumors within the kidneys (multiple synchronous or single/multiple metachronous) are not eligible if there are no extrarenal sites of disease (i.e. potential multifocal primary disease)",
            "criterions": [
                {
                    "exact_snippets": "tumors within the kidneys (multiple synchronous or single/multiple metachronous)",
                    "criterion": "tumors within the kidneys",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "synchronous/metachronous",
                            "expected_value": [
                                "multiple synchronous",
                                "single/multiple metachronous"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "extrarenal sites of disease",
                    "criterion": "extrarenal sites of disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must not have received any prior or concurrent systemic therapy for RCC. Adjuvant placebo administration is permitted",
            "criterions": [
                {
                    "exact_snippets": "Patient must not have received any prior or concurrent systemic therapy for RCC.",
                    "criterion": "systemic therapy for RCC",
                    "requirements": [
                        {
                            "requirement_type": "prior or concurrent administration",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Adjuvant placebo administration is permitted",
                    "criterion": "adjuvant placebo administration",
                    "requirements": [
                        {
                            "requirement_type": "permission",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must have no active peptic ulcer disease",
            "criterions": [
                {
                    "exact_snippets": "no active peptic ulcer disease",
                    "criterion": "peptic ulcer disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must have no active inflammatory bowel disease",
            "criterions": [
                {
                    "exact_snippets": "no active inflammatory bowel disease",
                    "criterion": "inflammatory bowel disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must have no New York Heart Association (NYHA) class II or greater congestive heart failure",
            "criterions": [
                {
                    "exact_snippets": "no New York Heart Association (NYHA) class II or greater congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "NYHA class"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must have no prior history or current clinically apparent central nervous system metastases",
            "criterions": [
                {
                    "exact_snippets": "no prior history ... central nervous system metastases",
                    "criterion": "central nervous system metastases",
                    "requirements": [
                        {
                            "requirement_type": "prior history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no ... current clinically apparent central nervous system metastases",
                    "criterion": "central nervous system metastases",
                    "requirements": [
                        {
                            "requirement_type": "current clinically apparent",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women must not be pregnant or breast-feeding due to the unknown effects of pazopanib on the developing fetus",
            "criterions": [
                {
                    "exact_snippets": "Women must not be pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding",
                    "criterion": "breast-feeding",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must have no history of allergic reactions attributed to compounds of similar chemical or biologic composition to pazopanib",
            "criterions": [
                {
                    "exact_snippets": "no history of allergic reactions attributed to compounds of similar chemical or biologic composition to pazopanib",
                    "criterion": "allergic reactions to compounds similar to pazopanib",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must have no uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled intercurrent illness",
                    "criterion": "uncontrolled intercurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "ongoing or active infection",
                    "criterion": "ongoing or active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic congestive heart failure",
                    "criterion": "symptomatic congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "psychiatric illness/social situations that would limit compliance with study requirements",
                    "criterion": "psychiatric illness/social situations",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": "would not limit compliance"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must not have serious or non-healing wound, ulcer, or bone fracture at the time of randomization",
            "criterions": [
                {
                    "exact_snippets": "serious or non-healing wound",
                    "criterion": "wound",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "not serious or non-healing"
                        }
                    ]
                },
                {
                    "exact_snippets": "ulcer",
                    "criterion": "ulcer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "bone fracture",
                    "criterion": "bone fracture",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "not non-healing"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must have no history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to randomization",
            "criterions": [
                {
                    "exact_snippets": "no history of abdominal fistula",
                    "criterion": "abdominal fistula",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no history of ... gastrointestinal perforation",
                    "criterion": "gastrointestinal perforation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no history of ... intra-abdominal abscess",
                    "criterion": "intra-abdominal abscess",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "within 4 weeks prior to randomization",
                    "criterion": "time since last occurrence of specified conditions",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must have no history of myocardial infarction, hospital admission for unstable angina, cardiac angioplasty or stenting within 6 months of randomization",
            "criterions": [
                {
                    "exact_snippets": "no history of myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no history of ... hospital admission for unstable angina",
                    "criterion": "hospital admission for unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no history of ... cardiac angioplasty or stenting within 6 months of randomization",
                    "criterion": "cardiac angioplasty or stenting",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must have no history venous thrombosis within 12 weeks of randomization",
            "criterions": [
                {
                    "exact_snippets": "no history venous thrombosis within 12 weeks of randomization",
                    "criterion": "venous thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient cannot be taking strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors such as:",
            "criterions": [
                {
                    "exact_snippets": "Patient cannot be taking strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors",
                    "criterion": "CYP3A4 inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Antibiotics: clarithromycin, telithromycin, troleandomycin",
            "criterions": [
                {
                    "exact_snippets": "Antibiotics: clarithromycin, telithromycin, troleandomycin",
                    "criterion": "antibiotics",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "clarithromycin",
                                "telithromycin",
                                "troleandomycin"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Human immunodeficiency virus (HIV) antiviral protease inhibitors: ritonavir, indinavir, saquinavir, nelfinavir, amprenavir, lopinavir",
            "criterions": [
                {
                    "exact_snippets": "Human immunodeficiency virus (HIV) antiviral protease inhibitors: ritonavir, indinavir, saquinavir, nelfinavir, amprenavir, lopinavir",
                    "criterion": "HIV antiviral protease inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "ritonavir",
                                "indinavir",
                                "saquinavir",
                                "nelfinavir",
                                "amprenavir",
                                "lopinavir"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Antifungals: itraconazole, ketoconazole, voriconazole, fluconazole",
            "criterions": [
                {
                    "exact_snippets": "Antifungals: itraconazole, ketoconazole, voriconazole, fluconazole",
                    "criterion": "antifungal medications",
                    "requirements": [
                        {
                            "requirement_type": "specific medications",
                            "expected_value": [
                                "itraconazole",
                                "ketoconazole",
                                "voriconazole",
                                "fluconazole"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Antidepressants: nefazodone",
            "criterions": [
                {
                    "exact_snippets": "Antidepressants: nefazodone",
                    "criterion": "antidepressant use",
                    "requirements": [
                        {
                            "requirement_type": "specific drug",
                            "expected_value": "nefazodone"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must not have history of hemoptysis in excess of 2.5 mL (1/2 teaspoon) within 8 weeks prior to randomization",
            "criterions": [
                {
                    "exact_snippets": "history of hemoptysis",
                    "criterion": "history of hemoptysis",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "mL"
                            }
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 8 weeks prior to randomization"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must not be taking drugs known to prolong the QTc interval; such drugs should be discontinued at least 5 half-lives prior to randomization",
            "criterions": [
                {
                    "exact_snippets": "Patient must not be taking drugs known to prolong the QTc interval",
                    "criterion": "drugs known to prolong the QTc interval",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "such drugs should be discontinued at least 5 half-lives prior to randomization",
                    "criterion": "discontinuation of drugs known to prolong the QTc interval",
                    "requirements": [
                        {
                            "requirement_type": "time before randomization",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "half-lives"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must not have any history of other cancer within 3 years from time of randomization with the exception of basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or resected non-invasive (Ta) urothelial carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Patients must not have any history of other cancer within 3 years from time of randomization",
                    "criterion": "history of other cancer",
                    "requirements": [
                        {
                            "requirement_type": "time since last occurrence",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "with the exception of basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or resected non-invasive (Ta) urothelial carcinoma",
                    "criterion": "exceptions to cancer history",
                    "requirements": [
                        {
                            "requirement_type": "cancer types",
                            "expected_value": [
                                "basal cell skin cancer",
                                "squamous cell skin cancer",
                                "in situ cervical cancer",
                                "ductal or lobular carcinoma in situ of the breast",
                                "resected non-invasive (Ta) urothelial carcinoma"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}