{
    "info": {
        "nct_id": "NCT00062231",
        "official_title": "Oral Empirical Therapy of Fever in Low-Risk Neutropenic Cancer Patients: A Prospective, Double-Blind, Randomized, Multicenter Trial Comparing Monotherapy (Single Daily Dose Moxifloxacin) With Combination Therapy (Ciprofloxacin Plus Amoxicillin/Clavulanic Acid)",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Diagnosis of cancer with developing febrile neutropenia\n\n  * Neutropenia defined as an absolute granulocyte count of less than 1,000/mm^3, expected to fall to less than 500/mm^3 within 24 hours, secondary to administration of chemotherapy and/or radiotherapy within the past 30 days\n  * Fever defined as an oral temperature greater than 38.5ºC once, or 38°C or greater on 2 or more occasions at least 1 hour apart during a 12-hour period, and suspected to be due to infection\n* Expected low risk of serious medical complications as predicted by a Multinational Association for Supportive Care in Cancer risk-index score of greater than 20\n* No obvious signs of exit-site or tunnel intravascular catheter infection\n* No known or suspected CNS infection\n* No known or highly suspected bacterial, viral, or fungal infection\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* Not specified\n\nLife expectancy\n\n* No high probability of death within 48 hours before study enrollment (i.e., patients who are moribund or comatose for any reason with little hope of recovery OR patients in danger of, or in hepatic stupor or coma)\n\nHematopoietic\n\n* See Disease Characteristics\n* No signs or symptoms of uncontrolled bleeding\n\nHepatic\n\n* Bilirubin no greater than 3 times upper limit of normal (ULN)\n* Alkaline phosphatase no greater than 3 times ULN\n* AST and ALT no greater than 5 times ULN\n* No severe hepatic dysfunction\n\nRenal\n\n* Creatinine no greater than 3.4 mg/dL\n* Creatinine clearance at least 25 mL/min\n* No renal failure requiring hemodialysis or peritoneal dialysis\n\nCardiovascular\n\n* No prior symptomatic arrhythmias\n* No clinically relevant bradycardia\n* No QTc interval prolongation\n* No uncorrected hypokalemia\n* No signs or symptoms of hypotension (systolic less than 90 mm Hg)\n\nPulmonary\n\n* No signs or symptoms of respiratory insufficiency\n\nOther\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* Able to swallow oral medication\n* No contraindication for oral drug intake\n* No condition likely to severely impair drug absorption\n* No prior immediate or accelerated reaction to penicillin, cephalosporin, or fluoroquinolone antibiotics\n* No known allergy or hypersensitivity to any antibiotics in this study or other quinolones\n* No signs or symptoms of severe dehydration\n* No signs or symptoms of shock\n* No other signs or symptoms at presentation that would necessitate IV supportive therapy\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* See Disease Characteristics\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* See Disease Characteristics\n\nSurgery\n\n* Not specified\n\nOther\n\n* More than 4 days since prior antibacterial agents except for the following:\n\n  * A single (oral or parenteral therapeutic) dose after initial diagnosic work-up and within the last 8 hours\n  * Low-dose cotrimoxazole (i.e., no more than 480 mg daily or 960 mg 3 times per week) prophylaxis of Pneumocystis carinii pneumonia\n* More than 30 days since prior investigational drugs\n* No prior randomization in this study\n* No other concurrent antimicrobial agents\n* No class IA or class III antiarrhythmic drugs or other concurrent drugs that prolong the QTc interval"
    },
    "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 cancer with developing febrile neutropenia",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of cancer",
                    "criterion": "cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "developing febrile neutropenia",
                    "criterion": "febrile neutropenia",
                    "requirements": [
                        {
                            "requirement_type": "development",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Neutropenia defined as an absolute granulocyte count of less than 1,000/mm^3, expected to fall to less than 500/mm^3 within 24 hours, secondary to administration of chemotherapy and/or radiotherapy within the past 30 days",
            "criterions": [
                {
                    "exact_snippets": "Neutropenia defined as an absolute granulocyte count of less than 1,000/mm^3",
                    "criterion": "absolute granulocyte count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "expected to fall to less than 500/mm^3 within 24 hours",
                    "criterion": "absolute granulocyte count",
                    "requirements": [
                        {
                            "requirement_type": "expected future quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 500,
                                "unit": "mm^3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "secondary to administration of chemotherapy and/or radiotherapy within the past 30 days",
                    "criterion": "administration of chemotherapy and/or radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the past 30 days"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fever defined as an oral temperature greater than 38.5ºC once, or 38°C or greater on 2 or more occasions at least 1 hour apart during a 12-hour period, and suspected to be due to infection",
            "criterions": [
                {
                    "exact_snippets": "Fever defined as an oral temperature greater than 38.5ºC once",
                    "criterion": "fever",
                    "requirements": [
                        {
                            "requirement_type": "temperature",
                            "expected_value": {
                                "operator": ">",
                                "value": 38.5,
                                "unit": "ºC"
                            }
                        },
                        {
                            "requirement_type": "frequency",
                            "expected_value": "once"
                        }
                    ]
                },
                {
                    "exact_snippets": "Fever defined as an oral temperature ... 38°C or greater on 2 or more occasions at least 1 hour apart during a 12-hour period",
                    "criterion": "fever",
                    "requirements": [
                        {
                            "requirement_type": "temperature",
                            "expected_value": {
                                "operator": ">=",
                                "value": 38,
                                "unit": "ºC"
                            }
                        },
                        {
                            "requirement_type": "frequency",
                            "expected_value": "2 or more occasions"
                        },
                        {
                            "requirement_type": "time_interval",
                            "expected_value": "at least 1 hour apart during a 12-hour period"
                        }
                    ]
                },
                {
                    "exact_snippets": "suspected to be due to infection",
                    "criterion": "cause of fever",
                    "requirements": [
                        {
                            "requirement_type": "suspected_cause",
                            "expected_value": "infection"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Expected low risk of serious medical complications as predicted by a Multinational Association for Supportive Care in Cancer risk-index score of greater than 20",
            "criterions": [
                {
                    "exact_snippets": "Multinational Association for Supportive Care in Cancer risk-index score of greater than 20",
                    "criterion": "Multinational Association for Supportive Care in Cancer risk-index score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No obvious signs of exit-site or tunnel intravascular catheter infection",
            "criterions": [
                {
                    "exact_snippets": "No obvious signs of exit-site ... catheter infection",
                    "criterion": "exit-site infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No obvious signs of ... tunnel intravascular catheter infection",
                    "criterion": "tunnel intravascular catheter infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No known or suspected CNS infection",
            "criterions": [
                {
                    "exact_snippets": "No known or suspected CNS infection",
                    "criterion": "CNS infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No known or highly suspected bacterial, viral, or fungal infection",
            "criterions": [
                {
                    "exact_snippets": "No known or highly suspected bacterial ... infection",
                    "criterion": "bacterial infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No known or highly suspected ... viral ... infection",
                    "criterion": "viral infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No known or highly suspected ... fungal infection",
                    "criterion": "fungal infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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": "Life expectancy",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No high probability of death within 48 hours before study enrollment (i.e., patients who are moribund or comatose for any reason with little hope of recovery OR patients in danger of, or in hepatic stupor or coma)",
            "criterions": [
                {
                    "exact_snippets": "high probability of death within 48 hours before study enrollment",
                    "criterion": "probability of death",
                    "requirements": [
                        {
                            "requirement_type": "probability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "patients who are moribund or comatose for any reason with little hope of recovery",
                    "criterion": "moribund or comatose state",
                    "requirements": [
                        {
                            "requirement_type": "state",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "patients in danger of, or in hepatic stupor or coma",
                    "criterion": "hepatic stupor or coma",
                    "requirements": [
                        {
                            "requirement_type": "state",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hematopoietic",
            "criterions": [
                {
                    "exact_snippets": "Hematopoietic",
                    "criterion": "hematopoietic system",
                    "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 disease characteristics"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No signs or symptoms of uncontrolled bleeding",
            "criterions": [
                {
                    "exact_snippets": "No signs or symptoms of uncontrolled bleeding",
                    "criterion": "uncontrolled bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hepatic",
            "criterions": [
                {
                    "exact_snippets": "Hepatic",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin no greater than 3 times upper limit of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin no greater than 3 times upper limit of normal (ULN)",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Alkaline phosphatase no greater than 3 times ULN",
            "criterions": [
                {
                    "exact_snippets": "Alkaline phosphatase no greater than 3 times ULN",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST and ALT no greater than 5 times ULN",
            "criterions": [
                {
                    "exact_snippets": "AST ... no greater than 5 times ULN",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT no greater than 5 times ULN",
                    "criterion": "ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No severe hepatic dysfunction",
            "criterions": [
                {
                    "exact_snippets": "No severe hepatic dysfunction",
                    "criterion": "hepatic dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Renal",
            "criterions": [
                {
                    "exact_snippets": "Renal",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine no greater than 3.4 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Creatinine no greater than 3.4 mg/dL",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3.4,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine clearance at least 25 mL/min",
            "criterions": [
                {
                    "exact_snippets": "Creatinine clearance at least 25 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 25,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No renal failure requiring hemodialysis or peritoneal dialysis",
            "criterions": [
                {
                    "exact_snippets": "No renal failure requiring hemodialysis or peritoneal dialysis",
                    "criterion": "renal failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No renal failure requiring hemodialysis",
                    "criterion": "hemodialysis",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No renal failure requiring ... peritoneal dialysis",
                    "criterion": "peritoneal dialysis",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Cardiovascular",
            "criterions": [
                {
                    "exact_snippets": "Cardiovascular",
                    "criterion": "cardiovascular condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior symptomatic arrhythmias",
            "criterions": [
                {
                    "exact_snippets": "No prior symptomatic arrhythmias",
                    "criterion": "symptomatic arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No clinically relevant bradycardia",
            "criterions": [
                {
                    "exact_snippets": "No clinically relevant bradycardia",
                    "criterion": "bradycardia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not clinically relevant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No QTc interval prolongation",
            "criterions": [
                {
                    "exact_snippets": "No QTc interval prolongation",
                    "criterion": "QTc interval",
                    "requirements": [
                        {
                            "requirement_type": "prolongation",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No uncorrected hypokalemia",
            "criterions": [
                {
                    "exact_snippets": "No uncorrected hypokalemia",
                    "criterion": "hypokalemia",
                    "requirements": [
                        {
                            "requirement_type": "correction",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No signs or symptoms of hypotension (systolic less than 90 mm Hg)",
            "criterions": [
                {
                    "exact_snippets": "No signs or symptoms of hypotension",
                    "criterion": "hypotension",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "systolic less than 90 mm Hg",
                    "criterion": "systolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 90,
                                "unit": "mm Hg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Pulmonary",
            "criterions": [
                {
                    "exact_snippets": "Pulmonary",
                    "criterion": "pulmonary condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No signs or symptoms of respiratory insufficiency",
            "criterions": [
                {
                    "exact_snippets": "No signs or symptoms of respiratory insufficiency",
                    "criterion": "respiratory insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Able to swallow oral medication",
            "criterions": [
                {
                    "exact_snippets": "Able to swallow oral medication",
                    "criterion": "ability to swallow oral medication",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No contraindication for oral drug intake",
            "criterions": [
                {
                    "exact_snippets": "No contraindication for oral drug intake",
                    "criterion": "contraindication for oral drug intake",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No condition likely to severely impair drug absorption",
            "criterions": [
                {
                    "exact_snippets": "No condition likely to severely impair drug absorption",
                    "criterion": "condition affecting drug absorption",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior immediate or accelerated reaction to penicillin, cephalosporin, or fluoroquinolone antibiotics",
            "criterions": [
                {
                    "exact_snippets": "No prior immediate or accelerated reaction to penicillin",
                    "criterion": "reaction to penicillin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior immediate or accelerated reaction to ... cephalosporin",
                    "criterion": "reaction to cephalosporin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior immediate or accelerated reaction to ... fluoroquinolone antibiotics",
                    "criterion": "reaction to fluoroquinolone antibiotics",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No known allergy or hypersensitivity to any antibiotics in this study or other quinolones",
            "criterions": [
                {
                    "exact_snippets": "No known allergy or hypersensitivity to any antibiotics in this study",
                    "criterion": "allergy or hypersensitivity to antibiotics in this study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No known allergy or hypersensitivity to ... other quinolones",
                    "criterion": "allergy or hypersensitivity to quinolones",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No signs or symptoms of severe dehydration",
            "criterions": [
                {
                    "exact_snippets": "No signs or symptoms of severe dehydration",
                    "criterion": "severe dehydration",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No signs or symptoms of shock",
            "criterions": [
                {
                    "exact_snippets": "No signs or symptoms of shock",
                    "criterion": "shock",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other signs or symptoms at presentation that would necessitate IV supportive therapy",
            "criterions": [
                {
                    "exact_snippets": "No other signs or symptoms ... necessitate IV supportive therapy",
                    "criterion": "signs or symptoms necessitating IV supportive therapy",
                    "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": "Biologic therapy",
            "criterions": [
                {
                    "exact_snippets": "Biologic therapy",
                    "criterion": "biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy",
                    "criterion": "chemotherapy",
                    "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 disease characteristics"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Endocrine therapy",
            "criterions": [
                {
                    "exact_snippets": "Endocrine therapy",
                    "criterion": "endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "Radiotherapy",
                    "criterion": "radiotherapy",
                    "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 disease characteristics"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Surgery",
            "criterions": [
                {
                    "exact_snippets": "Surgery",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 4 days since prior antibacterial agents except for the following:",
            "criterions": [
                {
                    "exact_snippets": "More than 4 days since prior antibacterial agents",
                    "criterion": "time since prior antibacterial agents",
                    "requirements": [
                        {
                            "requirement_type": "time",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A single (oral or parenteral therapeutic) dose after initial diagnosic work-up and within the last 8 hours",
            "criterions": [
                {
                    "exact_snippets": "A single (oral or parenteral therapeutic) dose",
                    "criterion": "therapeutic dose",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "single"
                        },
                        {
                            "requirement_type": "route of administration",
                            "expected_value": [
                                "oral",
                                "parenteral"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "after initial diagnosic work-up",
                    "criterion": "timing of dose",
                    "requirements": [
                        {
                            "requirement_type": "sequence",
                            "expected_value": "after initial diagnostic work-up"
                        }
                    ]
                },
                {
                    "exact_snippets": "within the last 8 hours",
                    "criterion": "timing of dose",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 8,
                                "unit": "hours"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Low-dose cotrimoxazole (i.e., no more than 480 mg daily or 960 mg 3 times per week) prophylaxis of Pneumocystis carinii pneumonia",
            "criterions": [
                {
                    "exact_snippets": "Low-dose cotrimoxazole (i.e., no more than 480 mg daily or 960 mg 3 times per week)",
                    "criterion": "cotrimoxazole dosage",
                    "requirements": [
                        {
                            "requirement_type": "maximum dosage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 480,
                                        "unit": "mg/day"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 960,
                                        "unit": "mg/3 times per week"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "prophylaxis of Pneumocystis carinii pneumonia",
                    "criterion": "Pneumocystis carinii pneumonia prophylaxis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 30 days since prior investigational drugs",
            "criterions": [
                {
                    "exact_snippets": "More than 30 days since prior investigational drugs",
                    "criterion": "time since prior investigational drugs",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior randomization in this study",
            "criterions": [
                {
                    "exact_snippets": "No prior randomization in this study",
                    "criterion": "prior randomization",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent antimicrobial agents",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent antimicrobial agents",
                    "criterion": "concurrent antimicrobial agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No class IA or class III antiarrhythmic drugs or other concurrent drugs that prolong the QTc interval",
            "criterions": [
                {
                    "exact_snippets": "No class IA or class III antiarrhythmic drugs",
                    "criterion": "class IA or class III antiarrhythmic drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other concurrent drugs that prolong the QTc interval",
                    "criterion": "drugs that prolong the QTc interval",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "DISEASE CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "Other",
            "criterions": []
        },
        {
            "line": "* Not pregnant or nursing",
            "criterions": [
                {
                    "exact_snippets": "Not pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not ... nursing",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "Other",
            "criterions": []
        }
    ]
}