{
    "info": {
        "nct_id": "NCT00058331",
        "official_title": "A Phase III, Randomized Study Of Two Different Dosing Schedules Of Erythropoetin In Anemic Patients With Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Diagnosis of a nonmyeloid cancer (excluding nonmelanoma skin cancer)\n* Anemia secondary to cancer or cancer treatment*\n\n  * Hemoglobin less than 12 g/dL (males)\n  * Hemoglobin less than 11 g/dL (females) NOTE: *Active anticancer therapy is not required for study enrollment\n* Anemia must not be secondary to any of the following:\n\n  * B_12, folic acid, or iron deficiency\n\n    * Ferritin must be normal or elevated\n  * Gastrointestinal bleeding or hemolysis\n  * Primary or chemotherapy-induced myelodysplastic syndromes\n* No untreated CNS metastases\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* At least 6 months\n\nCardiovascular\n\n* No history of uncontrolled cardiac arrhythmias\n* No history of deep venous thrombosis within the past year (unless on anticoagulation)\n* No uncontrolled hypertension (systolic blood pressure at least 180 mm Hg and diastolic blood pressure at least 100 mm Hg) within the past year (unless on anticoagulation)\n\nPulmonary\n\n* No history of pulmonary embolism within the past year (unless on anticoagulation)\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 3 months after study participation\n* No known hypersensitivity to epoetin alfa, mammalian cell-derived products, or human albumin\n* No new onset of seizures within the past 3 months\n* No poorly controlled seizures\n* Able and willing to complete quality of life forms\n* Alert and mentally competent to give informed consent\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* More than 6 months since prior epoetin alfa\n* More than 6 months since any prior investigational forms of epoetin alfa (e.g., gene-activated epoetin alfa or novel erythropoiesis-stimulating protein)\n* No concurrent peripheral blood stem cell transplantation\n* No concurrent bone marrow transplantation\n\nSurgery\n\n* More than 14 days since prior major surgery\n\nOther\n\n* More than 2 weeks since prior red blood cell transfusions"
    },
    "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": "* Diagnosis of a nonmyeloid cancer (excluding nonmelanoma skin cancer)",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of a nonmyeloid cancer",
                    "criterion": "nonmyeloid cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding nonmelanoma skin cancer",
                    "criterion": "nonmelanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Anemia secondary to cancer or cancer treatment*",
            "criterions": [
                {
                    "exact_snippets": "Anemia secondary to cancer",
                    "criterion": "anemia",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "cancer"
                        }
                    ]
                },
                {
                    "exact_snippets": "Anemia secondary to ... cancer treatment",
                    "criterion": "anemia",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "cancer treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin less than 12 g/dL (males)",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin less than 12 g/dL (males)",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 12,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin less than 11 g/dL (females) NOTE: *Active anticancer therapy is not required for study enrollment",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin less than 11 g/dL (females)",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 11,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Anemia must not be secondary to any of the following:",
            "criterions": [
                {
                    "exact_snippets": "Anemia must not be secondary to any of the following",
                    "criterion": "anemia",
                    "requirements": [
                        {
                            "requirement_type": "secondary cause",
                            "expected_value": "none of the following"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* B_12, folic acid, or iron deficiency",
            "criterions": [
                {
                    "exact_snippets": "B_12",
                    "criterion": "B_12 deficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "folic acid",
                    "criterion": "folic acid deficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "iron deficiency",
                    "criterion": "iron deficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ferritin must be normal or elevated",
            "criterions": [
                {
                    "exact_snippets": "Ferritin must be normal or elevated",
                    "criterion": "ferritin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": [
                                "normal",
                                "elevated"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Gastrointestinal bleeding or hemolysis",
            "criterions": [
                {
                    "exact_snippets": "Gastrointestinal bleeding",
                    "criterion": "gastrointestinal bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hemolysis",
                    "criterion": "hemolysis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Primary or chemotherapy-induced myelodysplastic syndromes",
            "criterions": [
                {
                    "exact_snippets": "Primary or chemotherapy-induced myelodysplastic syndromes",
                    "criterion": "myelodysplastic syndromes",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": [
                                "primary",
                                "chemotherapy-induced"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No untreated CNS metastases",
            "criterions": [
                {
                    "exact_snippets": "No untreated CNS metastases",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "treated"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* ECOG 0-2",
            "criterions": [
                {
                    "exact_snippets": "ECOG 0-2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "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 6 months",
            "criterions": [
                {
                    "exact_snippets": "At least 6 months",
                    "criterion": "duration",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Cardiovascular",
            "criterions": [
                {
                    "exact_snippets": "Cardiovascular",
                    "criterion": "cardiovascular condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of uncontrolled cardiac arrhythmias",
            "criterions": [
                {
                    "exact_snippets": "No history of uncontrolled cardiac arrhythmias",
                    "criterion": "cardiac arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "controlled"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of deep venous thrombosis within the past year (unless on anticoagulation)",
            "criterions": [
                {
                    "exact_snippets": "No history of deep venous thrombosis within the past year",
                    "criterion": "deep venous thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unless on anticoagulation",
                    "criterion": "anticoagulation",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No uncontrolled hypertension (systolic blood pressure at least 180 mm Hg and diastolic blood pressure at least 100 mm Hg) within the past year (unless on anticoagulation)",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled hypertension",
                    "criterion": "uncontrolled hypertension",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "systolic blood pressure at least 180 mm Hg",
                    "criterion": "systolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 180,
                                "unit": "mm Hg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "diastolic blood pressure at least 100 mm Hg",
                    "criterion": "diastolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "mm Hg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "within the past year",
                    "criterion": "time frame for blood pressure measurement",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the past year"
                        }
                    ]
                },
                {
                    "exact_snippets": "unless on anticoagulation",
                    "criterion": "anticoagulation status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "on anticoagulation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Pulmonary",
            "criterions": [
                {
                    "exact_snippets": "Pulmonary",
                    "criterion": "pulmonary condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of pulmonary embolism within the past year (unless on anticoagulation)",
            "criterions": [
                {
                    "exact_snippets": "No history of pulmonary embolism within the past year",
                    "criterion": "pulmonary embolism history",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "past year"
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unless on anticoagulation",
                    "criterion": "anticoagulation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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 3 months after study participation",
            "criterions": [
                {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    ]
                },
                {
                    "exact_snippets": "must use effective contraception during and for 3 months after study participation",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during and for 3 months after study participation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No known hypersensitivity to epoetin alfa, mammalian cell-derived products, or human albumin",
            "criterions": [
                {
                    "exact_snippets": "No known hypersensitivity to epoetin alfa",
                    "criterion": "hypersensitivity to epoetin alfa",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No known hypersensitivity to ... mammalian cell-derived products",
                    "criterion": "hypersensitivity to mammalian cell-derived products",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No known hypersensitivity to ... human albumin",
                    "criterion": "hypersensitivity to human albumin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No new onset of seizures within the past 3 months",
            "criterions": [
                {
                    "exact_snippets": "No new onset of seizures within the past 3 months",
                    "criterion": "new onset of seizures",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No poorly controlled seizures",
            "criterions": [
                {
                    "exact_snippets": "No poorly controlled seizures",
                    "criterion": "seizures",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "not poorly controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able and willing to complete quality of life forms",
            "criterions": [
                {
                    "exact_snippets": "Able and willing to complete quality of life forms",
                    "criterion": "ability and willingness to complete quality of life forms",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Alert and mentally competent to give informed consent",
            "criterions": [
                {
                    "exact_snippets": "Alert",
                    "criterion": "alertness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "mentally competent",
                    "criterion": "mental competence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "to give informed consent",
                    "criterion": "ability to give informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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": "* More than 6 months since prior epoetin alfa",
            "criterions": [
                {
                    "exact_snippets": "More than 6 months since prior epoetin alfa",
                    "criterion": "epoetin alfa administration",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 6 months since any prior investigational forms of epoetin alfa (e.g., gene-activated epoetin alfa or novel erythropoiesis-stimulating protein)",
            "criterions": [
                {
                    "exact_snippets": "More than 6 months since any prior investigational forms of epoetin alfa",
                    "criterion": "time since prior investigational epoetin alfa",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent peripheral blood stem cell transplantation",
            "criterions": [
                {
                    "exact_snippets": "No concurrent peripheral blood stem cell transplantation",
                    "criterion": "peripheral blood stem cell transplantation",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent bone marrow transplantation",
            "criterions": [
                {
                    "exact_snippets": "No concurrent bone marrow transplantation",
                    "criterion": "bone marrow transplantation",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Surgery",
            "criterions": [
                {
                    "exact_snippets": "Surgery",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 14 days since prior major surgery",
            "criterions": [
                {
                    "exact_snippets": "More than 14 days since prior major surgery",
                    "criterion": "time since prior major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 2 weeks since prior red blood cell transfusions",
            "criterions": [
                {
                    "exact_snippets": "More than 2 weeks since prior red blood cell transfusions",
                    "criterion": "time since prior red blood cell transfusions",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "DISEASE CHARACTERISTICS:",
            "criterions": []
        },
        {
            "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": "Other",
            "criterions": []
        }
    ]
}