{
    "info": {
        "nct_id": "NCT00277160",
        "official_title": "A Randomized, Open Label, Multicenter Study of Primary Prophylaxis With Neulasta (Pegfilgrastim) Versus Secondary Prophylaxis as an Adjunct to Chemotherapy in Elderly Subjects (>/= 65 Years Old) With Cancer",
        "inclusion_criteria": "* >/= 65 years old\n* documented diagnosis of lung, breast, or ovarian cancer, or NHL\n* scheduled to receive one of 15 standard chemotherapy regimens\n* chemotherapy naive OR have received adjuvant therapy AND/OR have no more than one regimen of chemotherapy for metastatic disease\n* life expectancy of at least 3 months\n* ECOG performance status </=2\n* adequate renal and hematologic function\n* informed consent for participation in the study prior to any study specific procedures\nHealthy volunteers allowed\nMust have minimum age of 65 Years",
        "exclusion_criteria": "* known hypersensitivity to any of the products to be administered during dosing\n* primary prophylactic antibiotics in all cycles\n* prior radiation therapy within 2 weeks of randomization into this study or plan for radiation therapy during study participation, except for spot radiation for bony metastases\n* prior bone marrow or stem cell transplant or plan to receive any transplant therapy during study participation\n* clinically symptomatic brain metastases\n* Folstein mini-mental state exam score <18\n* Any premalignant myeloid condition or any malignancy with myeloid characteristics\n* History of prior malignancy within the last 5 years other than subject's original cancer diagnosis listed in inclusion criteria with the exception of curatively treated basal cell carcinoma, squamous cell carcinoma, in situ cervical carcinoma or surgically cured malignancies\n* unstable/uncontrolled cardiac conditions or hypertension\n* active infection\n* subject is currently enrolled or has not yet completed at least 30 days since ending other investigational device or drug trial or is receiving other investigational agents",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* >/= 65 years old",
            "criterions": [
                {
                    "exact_snippets": ">/= 65 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 65,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* documented diagnosis of lung, breast, or ovarian cancer, or NHL",
            "criterions": [
                {
                    "exact_snippets": "documented diagnosis of lung ... cancer",
                    "criterion": "lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "documented diagnosis of ... breast ... cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "documented diagnosis of ... ovarian cancer",
                    "criterion": "ovarian cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "documented diagnosis of ... NHL",
                    "criterion": "NHL (Non-Hodgkin Lymphoma)",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* scheduled to receive one of 15 standard chemotherapy regimens",
            "criterions": [
                {
                    "exact_snippets": "scheduled to receive one of 15 standard chemotherapy regimens",
                    "criterion": "chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "scheduled",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 15,
                                "unit": "standard regimens"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* chemotherapy naive OR have received adjuvant therapy AND/OR have no more than one regimen of chemotherapy for metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "chemotherapy naive",
                    "criterion": "chemotherapy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "naive"
                        }
                    ]
                },
                {
                    "exact_snippets": "have received adjuvant therapy",
                    "criterion": "adjuvant therapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "received"
                        }
                    ]
                },
                {
                    "exact_snippets": "no more than one regimen of chemotherapy for metastatic disease",
                    "criterion": "chemotherapy regimen for metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "regimen"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* life expectancy of at least 3 months",
            "criterions": [
                {
                    "exact_snippets": "life expectancy of at least 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status </=2",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status </=2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* adequate renal and hematologic function",
            "criterions": [
                {
                    "exact_snippets": "adequate renal ... function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... hematologic function",
                    "criterion": "hematologic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* informed consent for participation in the study prior to any study specific procedures",
            "criterions": [
                {
                    "exact_snippets": "informed consent for participation in the study",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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 65 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 65 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 65,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* known hypersensitivity to any of the products to be administered during dosing",
            "criterions": [
                {
                    "exact_snippets": "known hypersensitivity to any of the products to be administered during dosing",
                    "criterion": "hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* primary prophylactic antibiotics in all cycles",
            "criterions": [
                {
                    "exact_snippets": "primary prophylactic antibiotics in all cycles",
                    "criterion": "primary prophylactic antibiotics",
                    "requirements": [
                        {
                            "requirement_type": "administration",
                            "expected_value": "in all cycles"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* prior radiation therapy within 2 weeks of randomization into this study or plan for radiation therapy during study participation, except for spot radiation for bony metastases",
            "criterions": [
                {
                    "exact_snippets": "prior radiation therapy within 2 weeks of randomization",
                    "criterion": "prior radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "plan for radiation therapy during study participation",
                    "criterion": "planned radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except for spot radiation for bony metastases",
                    "criterion": "spot radiation for bony metastases",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* prior bone marrow or stem cell transplant or plan to receive any transplant therapy during study participation",
            "criterions": [
                {
                    "exact_snippets": "prior bone marrow or stem cell transplant",
                    "criterion": "prior bone marrow or stem cell transplant",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "plan to receive any transplant therapy during study participation",
                    "criterion": "plan to receive transplant therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* clinically symptomatic brain metastases",
            "criterions": [
                {
                    "exact_snippets": "clinically symptomatic brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "symptom presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Folstein mini-mental state exam score <18",
            "criterions": [
                {
                    "exact_snippets": "Folstein mini-mental state exam score <18",
                    "criterion": "Folstein mini-mental state exam score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 18,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any premalignant myeloid condition or any malignancy with myeloid characteristics",
            "criterions": [
                {
                    "exact_snippets": "Any premalignant myeloid condition",
                    "criterion": "premalignant myeloid condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any malignancy with myeloid characteristics",
                    "criterion": "malignancy with myeloid characteristics",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of prior malignancy within the last 5 years other than subject's original cancer diagnosis listed in inclusion criteria with the exception of curatively treated basal cell carcinoma, squamous cell carcinoma, in situ cervical carcinoma or surgically cured malignancies",
            "criterions": [
                {
                    "exact_snippets": "History of prior malignancy within the last 5 years",
                    "criterion": "prior malignancy",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "curatively treated basal cell carcinoma, squamous cell carcinoma, in situ cervical carcinoma or surgically cured malignancies",
                    "criterion": "curatively treated malignancies",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "basal cell carcinoma",
                                "squamous cell carcinoma",
                                "in situ cervical carcinoma",
                                "surgically cured malignancies"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* unstable/uncontrolled cardiac conditions or hypertension",
            "criterions": [
                {
                    "exact_snippets": "unstable/uncontrolled cardiac conditions",
                    "criterion": "cardiac conditions",
                    "requirements": [
                        {
                            "requirement_type": "stability/control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "stability/control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* active infection",
            "criterions": [
                {
                    "exact_snippets": "active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* subject is currently enrolled or has not yet completed at least 30 days since ending other investigational device or drug trial or is receiving other investigational agents",
            "criterions": [
                {
                    "exact_snippets": "subject is currently enrolled ... other investigational device or drug trial",
                    "criterion": "enrollment in other investigational trial",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "has not yet completed at least 30 days since ending other investigational device or drug trial",
                    "criterion": "time since ending other investigational trial",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "is receiving other investigational agents",
                    "criterion": "receiving other investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}