{
    "info": {
        "nct_id": "NCT01394991",
        "official_title": "A Randomized, Open-Label, Multicenter Study Evaluating Thrombovascular Events in Subjects With Cancer Receiving Chemotherapy and Administered Epoetin Alfa Once or Three Times a Week for the Treatment of Anemia",
        "inclusion_criteria": "* Any nonmyeloid tumor confirmed by cytology and/or histology\n* Day 1 baseline hemoglobin (Hb) level <=11 g/dL\n* Expected to receive at least 12 weeks of chemotherapy after enrollment into the study\n* Eastern Cooperative Oncology Group (ECOG) performance status <= 2\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* History of active second cancer except for adequately treated skin cancer and in situ (pre-invasive) cervical cancer\n* History of deep venous thrombosis (DVT) (blood clots in the veins of the thighs or legs) or pulmonary embolism (PE) (blood clot in the lungs) within 12 months before study entry or at any time if the event is related to the current cancer, which is defined as diagnosis of the cancer within 3 months of a DVT/PE episode or a DVT/PE following the cancer diagnosis/treatment\n* History of cardiovascular accident (CVA), transient ischemic attack (TIA) (stroke), acute coronary syndrome (ACS) (a condition indicating damage to the heart), or other arterial thrombosis (blood clots) within 6 months before study entry\n* Onset of seizures within 3 months before randomization or poorly controlled seizures\n* Brain tumor or brain metastasis from another malignancy or cardiac disease that is markedly or completely limiting, uncontrolled hypertension (high blood pressure), or anemia (a lack of red blood cells in the blood) for reasons other than cancer or chemotherapy\n* Specifically excluded concomitant medications or therapies including prophylactic anticoagulation therapy for recurrence of prior thrombovascular event (TVE) (warfarin, unfractionated heparin, low molecular weight heparin [LMWH], except for prevention of central venous catheter thrombosis at doses specified in the protocol, direct thrombin inhibitors, or anti-platelet drugs [e.g., clopidogrel or ticlopidine]), except for prophylaxis in patients with known cardiovascular disease",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Any nonmyeloid tumor confirmed by cytology and/or histology",
            "criterions": [
                {
                    "exact_snippets": "nonmyeloid tumor confirmed by cytology and/or histology",
                    "criterion": "nonmyeloid tumor",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "cytology",
                                "histology"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Day 1 baseline hemoglobin (Hb) level <=11 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Day 1 baseline hemoglobin (Hb) level <=11 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 11,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Expected to receive at least 12 weeks of chemotherapy after enrollment into the study",
            "criterions": [
                {
                    "exact_snippets": "Expected to receive at least 12 weeks of chemotherapy",
                    "criterion": "chemotherapy duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status <= 2",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status <= 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* History of active second cancer except for adequately treated skin cancer and in situ (pre-invasive) cervical cancer",
            "criterions": [
                {
                    "exact_snippets": "History of active second cancer",
                    "criterion": "active second cancer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except for adequately treated skin cancer",
                    "criterion": "adequately treated skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ... in situ (pre-invasive) cervical cancer",
                    "criterion": "in situ cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "invasiveness",
                            "expected_value": "pre-invasive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of cardiovascular accident (CVA), transient ischemic attack (TIA) (stroke), acute coronary syndrome (ACS) (a condition indicating damage to the heart), or other arterial thrombosis (blood clots) within 6 months before study entry",
            "criterions": [
                {
                    "exact_snippets": "History of cardiovascular accident (CVA) ... within 6 months before study entry",
                    "criterion": "cardiovascular accident (CVA)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... transient ischemic attack (TIA) (stroke) ... within 6 months before study entry",
                    "criterion": "transient ischemic attack (TIA)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... acute coronary syndrome (ACS) (a condition indicating damage to the heart) ... within 6 months before study entry",
                    "criterion": "acute coronary syndrome (ACS)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... other arterial thrombosis (blood clots) within 6 months before study entry",
                    "criterion": "arterial thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Onset of seizures within 3 months before randomization or poorly controlled seizures",
            "criterions": [
                {
                    "exact_snippets": "Onset of seizures within 3 months before randomization",
                    "criterion": "seizure onset",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "poorly controlled seizures",
                    "criterion": "seizure control",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Brain tumor or brain metastasis from another malignancy or cardiac disease that is markedly or completely limiting, uncontrolled hypertension (high blood pressure), or anemia (a lack of red blood cells in the blood) for reasons other than cancer or chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Brain tumor",
                    "criterion": "brain tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "brain metastasis from another malignancy",
                    "criterion": "brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "origin",
                            "expected_value": "another malignancy"
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac disease that is markedly or completely limiting",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "markedly or completely limiting"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled hypertension (high blood pressure)",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "anemia (a lack of red blood cells in the blood) for reasons other than cancer or chemotherapy",
                    "criterion": "anemia",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "reasons other than cancer or chemotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Specifically excluded concomitant medications or therapies including prophylactic anticoagulation therapy for recurrence of prior thrombovascular event (TVE) (warfarin, unfractionated heparin, low molecular weight heparin [LMWH], except for prevention of central venous catheter thrombosis at doses specified in the protocol, direct thrombin inhibitors, or anti-platelet drugs [e.g., clopidogrel or ticlopidine]), except for prophylaxis in patients with known cardiovascular disease",
            "criterions": [
                {
                    "exact_snippets": "Specifically excluded concomitant medications or therapies including prophylactic anticoagulation therapy for recurrence of prior thrombovascular event (TVE) (warfarin, unfractionated heparin, low molecular weight heparin [LMWH], ... direct thrombin inhibitors, or anti-platelet drugs [e.g., clopidogrel or ticlopidine])",
                    "criterion": "concomitant medications or therapies",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "prophylactic anticoagulation therapy for recurrence of prior thrombovascular event (TVE)",
                                "warfarin",
                                "unfractionated heparin",
                                "low molecular weight heparin [LMWH]",
                                "direct thrombin inhibitors",
                                "anti-platelet drugs [e.g., clopidogrel or ticlopidine]"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "except for prevention of central venous catheter thrombosis at doses specified in the protocol",
                    "criterion": "prevention of central venous catheter thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except for prophylaxis in patients with known cardiovascular disease",
                    "criterion": "prophylaxis in patients with known cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* History of deep venous thrombosis (DVT) (blood clots in the veins of the thighs or legs) or pulmonary embolism (PE) (blood clot in the lungs) within 12 months before study entry or at any time if the event is related to the current cancer, which is defined as diagnosis of the cancer within 3 months of a DVT/PE episode or a DVT/PE following the cancer diagnosis/treatment",
            "criterions": [
                {
                    "exact_snippets": "History of deep venous thrombosis (DVT) ... within 12 months before study entry",
                    "criterion": "history of deep venous thrombosis (DVT)",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "History of deep venous thrombosis (DVT) ... at any time if the event is related to the current cancer",
                    "criterion": "history of deep venous thrombosis (DVT)",
                    "requirements": [
                        {
                            "requirement_type": "relation to current cancer",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of pulmonary embolism (PE) ... within 12 months before study entry",
                    "criterion": "history of pulmonary embolism (PE)",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "History of pulmonary embolism (PE) ... at any time if the event is related to the current cancer",
                    "criterion": "history of pulmonary embolism (PE)",
                    "requirements": [
                        {
                            "requirement_type": "relation to current cancer",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}