{
    "info": {
        "nct_id": "NCT00770172",
        "official_title": "Moderate Persistent Neutropenia: Comparison of Administration of G-CSF (Granulocyte Colony Stimulating Factor) 1 Day Out of 2 Versus Traditional Schedules to Maintain Dose Intensity. Phase III Multicenter Study in Patients With Solid Tumors Receiving Chemotherapy",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Diagnosis of solid tumor\n* Receiving chemotherapy in any line of treatment (adjuvant or metastatic)\n\n  * Chemotherapy courses repeating every 21 days or beginning on day 8 allowed\n  * Received at least 2 prior courses of chemotherapy\n* Moderate neutropenia (grade 1-3) leading to a delay of the first course by ≥ 7 days or a delay of the second course of treatment\n\nPATIENT CHARACTERISTICS:\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No known hypersensitivity to filgrastim (G-CSF) or any of its components\n* No severe immunodepression\n* No malignant hematological disease\n* No history of psychiatric illness\n* No patients deprived of liberty or under guardianship\n* No psychological, familial, social, or geographical reasons preventing follow-up\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics"
    },
    "inclusion_lines": [
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "DISEASE CHARACTERISTICS:",
            "criterions": [
                {
                    "exact_snippets": "DISEASE CHARACTERISTICS",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosis of solid tumor",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of solid tumor",
                    "criterion": "solid tumor",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Receiving chemotherapy in any line of treatment (adjuvant or metastatic)",
            "criterions": [
                {
                    "exact_snippets": "Receiving chemotherapy in any line of treatment (adjuvant or metastatic)",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "treatment line",
                            "expected_value": [
                                "adjuvant",
                                "metastatic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Chemotherapy courses repeating every 21 days or beginning on day 8 allowed",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy courses repeating every 21 days",
                    "criterion": "chemotherapy course schedule",
                    "requirements": [
                        {
                            "requirement_type": "repetition interval",
                            "expected_value": {
                                "operator": "=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Chemotherapy courses ... beginning on day 8 allowed",
                    "criterion": "chemotherapy course start day",
                    "requirements": [
                        {
                            "requirement_type": "start day",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Received at least 2 prior courses of chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Received at least 2 prior courses of chemotherapy",
                    "criterion": "prior courses of chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "courses"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Moderate neutropenia (grade 1-3) leading to a delay of the first course by ≥ 7 days or a delay of the second course of treatment",
            "criterions": [
                {
                    "exact_snippets": "Moderate neutropenia (grade 1-3)",
                    "criterion": "neutropenia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "grade"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "grade"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "delay of the first course by ≥ 7 days",
                    "criterion": "delay of the first course",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "delay of the second course of treatment",
                    "criterion": "delay of the second course",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fertile patients must use effective contraception",
            "criterions": [
                {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    ]
                },
                {
                    "exact_snippets": "must use effective contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No known hypersensitivity to filgrastim (G-CSF) or any of its components",
            "criterions": [
                {
                    "exact_snippets": "No known hypersensitivity to filgrastim (G-CSF)",
                    "criterion": "hypersensitivity to filgrastim (G-CSF)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No known hypersensitivity to ... any of its components",
                    "criterion": "hypersensitivity to components of filgrastim (G-CSF)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No severe immunodepression",
            "criterions": [
                {
                    "exact_snippets": "No severe immunodepression",
                    "criterion": "immunodepression",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No malignant hematological disease",
            "criterions": [
                {
                    "exact_snippets": "No malignant hematological disease",
                    "criterion": "malignant hematological disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of psychiatric illness",
            "criterions": [
                {
                    "exact_snippets": "No history of psychiatric illness",
                    "criterion": "psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No patients deprived of liberty or under guardianship",
            "criterions": [
                {
                    "exact_snippets": "No patients deprived of liberty",
                    "criterion": "deprivation of liberty",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No patients ... under guardianship",
                    "criterion": "guardianship",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No psychological, familial, social, or geographical reasons preventing follow-up",
            "criterions": [
                {
                    "exact_snippets": "No psychological ... reasons preventing follow-up",
                    "criterion": "psychological reasons",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... familial ... reasons preventing follow-up",
                    "criterion": "familial reasons",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... social ... reasons preventing follow-up",
                    "criterion": "social reasons",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... geographical reasons preventing follow-up",
                    "criterion": "geographical reasons",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY:",
            "criterions": [
                {
                    "exact_snippets": "PRIOR CONCURRENT THERAPY",
                    "criterion": "prior concurrent therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* See Disease Characteristics",
            "criterions": [
                {
                    "exact_snippets": "Disease Characteristics",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "see referenced section"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "PATIENT CHARACTERISTICS:",
            "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
                        }
                    ]
                }
            ]
        }
    ]
}