{
    "info": {
        "nct_id": "NCT00072462",
        "official_title": "International Breast Cancer Intervention Study II (IBIS-II) (DCIS)",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 40 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Diagnosis of ductal carcinoma in situ within the past 6 months\n\n  * Locally excised with tumor-free margins at least 1 mm\n* Hormone receptor status:\n\n  * Estrogen or progesterone receptor positive\n\n    * Equal to or greater than 5% positive cells\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 40 to 70\n\nSex\n\n* Female\n\nMenopausal status\n\n* Postmenopausal, defined as meeting at least 1 of the following criteria:\n\n  * Over age 60\n  * Prior bilateral oophorectomy\n  * Age 60 or under with a uterus AND amenorrhea for at least the past 12 months\n  * Age 60 or under without a uterus AND follicle-stimulating hormone greater than 20 IU/L\n\nPerformance status\n\n* Not specified\n\nLife expectancy\n\n* At least 10 years\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Not specified\n\nCardiovascular\n\n* No prior deep vein thrombosis\n* No prior transient ischemic attack\n* No prior cerebrovascular accident\n\nPulmonary\n\n* No prior pulmonary embolism\n\nOther\n\n* No unexplained postmenopausal bleeding\n* No other cancer within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix\n* No other concurrent medical condition that would preclude study therapy, place the patient at unusual risk, or confound study results\n* No evidence of osteoporosis\n* Fragility fractures within the spine allowed if T-score level is greater than -4 and consist of no more than 2 fractures\n* Psychologically and physically suitable for 5 years of study therapy\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* Not specified\n\nEndocrine therapy\n\n* No prior or concurrent tamoxifen use lasting more than 6 months unless treatment was completed more than 5 years ago. Women in IBIS-I can join if off trial therapy for at least 5 years.\n* No prior or concurrent raloxifene use lasting more than 6 months unless treatment was completed more than 5 years ago.\n* No other prior or concurrent selective estrogen-receptor modulator use lasting more than 6 months unless treatment was completed more than 5 years ago\n* No concurrent systemic estrogen-based hormone replacement therapy, including vaginal estrogen preparations\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* See Disease Characteristics\n* No prior mastectomy\n* No planned prophylactic mastectomy\n\nOther\n\n* At least 3 months since prior unapproved or experimental agents\n* No concurrent anticoagulants"
    },
    "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 be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 40 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 40 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 40,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 70 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "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 ductal carcinoma in situ within the past 6 months",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of ductal carcinoma in situ",
                    "criterion": "ductal carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within the past 6 months",
                    "criterion": "time since diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Locally excised with tumor-free margins at least 1 mm",
            "criterions": [
                {
                    "exact_snippets": "Locally excised",
                    "criterion": "tumor excision",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "local"
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor-free margins at least 1 mm",
                    "criterion": "tumor-free margins",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hormone receptor status:",
            "criterions": [
                {
                    "exact_snippets": "Hormone receptor status",
                    "criterion": "hormone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Estrogen or progesterone receptor positive",
            "criterions": [
                {
                    "exact_snippets": "Estrogen ... receptor positive",
                    "criterion": "estrogen receptor",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "progesterone receptor positive",
                    "criterion": "progesterone receptor",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Equal to or greater than 5% positive cells",
            "criterions": [
                {
                    "exact_snippets": "Equal to or greater than 5% positive cells",
                    "criterion": "positive cells",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Age",
            "criterions": [
                {
                    "exact_snippets": "Age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 40 to 70",
            "criterions": [
                {
                    "exact_snippets": "40 to 70",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 40,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Sex",
            "criterions": [
                {
                    "exact_snippets": "Sex",
                    "criterion": "sex",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female",
            "criterions": [
                {
                    "exact_snippets": "Female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Menopausal status",
            "criterions": [
                {
                    "exact_snippets": "Menopausal status",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Postmenopausal, defined as meeting at least 1 of the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "Postmenopausal",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "postmenopausal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Over age 60",
            "criterions": [
                {
                    "exact_snippets": "Over age 60",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior bilateral oophorectomy",
            "criterions": [
                {
                    "exact_snippets": "Prior bilateral oophorectomy",
                    "criterion": "bilateral oophorectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age 60 or under with a uterus AND amenorrhea for at least the past 12 months",
            "criterions": [
                {
                    "exact_snippets": "Age 60 or under",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 60,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "with a uterus",
                    "criterion": "uterus presence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "amenorrhea for at least the past 12 months",
                    "criterion": "amenorrhea",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age 60 or under without a uterus AND follicle-stimulating hormone greater than 20 IU/L",
            "criterions": [
                {
                    "exact_snippets": "Age 60 or under",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 60,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "without a uterus",
                    "criterion": "uterus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "follicle-stimulating hormone greater than 20 IU/L",
                    "criterion": "follicle-stimulating hormone",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "IU/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* At least 10 years",
            "criterions": [
                {
                    "exact_snippets": "At least 10 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hematopoietic",
            "criterions": [
                {
                    "exact_snippets": "Hematopoietic",
                    "criterion": "hematopoietic system",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hepatic",
            "criterions": [
                {
                    "exact_snippets": "Hepatic",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Renal",
            "criterions": [
                {
                    "exact_snippets": "Renal",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Cardiovascular",
            "criterions": [
                {
                    "exact_snippets": "Cardiovascular",
                    "criterion": "cardiovascular condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior deep vein thrombosis",
            "criterions": [
                {
                    "exact_snippets": "No prior deep vein thrombosis",
                    "criterion": "deep vein thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior transient ischemic attack",
            "criterions": [
                {
                    "exact_snippets": "No prior transient ischemic attack",
                    "criterion": "transient ischemic attack",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior cerebrovascular accident",
            "criterions": [
                {
                    "exact_snippets": "No prior cerebrovascular accident",
                    "criterion": "cerebrovascular accident",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Pulmonary",
            "criterions": [
                {
                    "exact_snippets": "Pulmonary",
                    "criterion": "pulmonary condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior pulmonary embolism",
            "criterions": [
                {
                    "exact_snippets": "No prior pulmonary embolism",
                    "criterion": "pulmonary embolism",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No unexplained postmenopausal bleeding",
            "criterions": [
                {
                    "exact_snippets": "No unexplained postmenopausal bleeding",
                    "criterion": "postmenopausal bleeding",
                    "requirements": [
                        {
                            "requirement_type": "explanation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other cancer within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix",
            "criterions": [
                {
                    "exact_snippets": "No other cancer within the past 5 years",
                    "criterion": "other cancer",
                    "requirements": [
                        {
                            "requirement_type": "time since diagnosis",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except nonmelanoma skin cancer",
                    "criterion": "nonmelanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... carcinoma in situ of the cervix",
                    "criterion": "carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent medical condition that would preclude study therapy, place the patient at unusual risk, or confound study results",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent medical condition that would preclude study therapy",
                    "criterion": "concurrent medical condition",
                    "requirements": [
                        {
                            "requirement_type": "impact on study therapy",
                            "expected_value": "does not preclude"
                        }
                    ]
                },
                {
                    "exact_snippets": "No other concurrent medical condition that would ... place the patient at unusual risk",
                    "criterion": "concurrent medical condition",
                    "requirements": [
                        {
                            "requirement_type": "risk to patient",
                            "expected_value": "does not place at unusual risk"
                        }
                    ]
                },
                {
                    "exact_snippets": "No other concurrent medical condition that would ... confound study results",
                    "criterion": "concurrent medical condition",
                    "requirements": [
                        {
                            "requirement_type": "impact on study results",
                            "expected_value": "does not confound"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No evidence of osteoporosis",
            "criterions": [
                {
                    "exact_snippets": "No evidence of osteoporosis",
                    "criterion": "osteoporosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fragility fractures within the spine allowed if T-score level is greater than -4 and consist of no more than 2 fractures",
            "criterions": [
                {
                    "exact_snippets": "Fragility fractures within the spine allowed",
                    "criterion": "fragility fractures within the spine",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "T-score level is greater than -4",
                    "criterion": "T-score level",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": -4,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no more than 2 fractures",
                    "criterion": "number of fractures",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Psychologically and physically suitable for 5 years of study therapy",
            "criterions": [
                {
                    "exact_snippets": "Psychologically ... suitable for 5 years of study therapy",
                    "criterion": "psychological suitability",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "physically suitable for 5 years of study therapy",
                    "criterion": "physical suitability",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY:",
            "criterions": [
                {
                    "exact_snippets": "PRIOR CONCURRENT THERAPY",
                    "criterion": "prior concurrent therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Biologic therapy",
            "criterions": [
                {
                    "exact_snippets": "Biologic therapy",
                    "criterion": "biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Endocrine therapy",
            "criterions": [
                {
                    "exact_snippets": "Endocrine therapy",
                    "criterion": "endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior or concurrent tamoxifen use lasting more than 6 months unless treatment was completed more than 5 years ago. Women in IBIS-I can join if off trial therapy for at least 5 years.",
            "criterions": [
                {
                    "exact_snippets": "No prior or concurrent tamoxifen use lasting more than 6 months",
                    "criterion": "tamoxifen use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unless treatment was completed more than 5 years ago",
                    "criterion": "tamoxifen use",
                    "requirements": [
                        {
                            "requirement_type": "completion time",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Women in IBIS-I can join if off trial therapy for at least 5 years",
                    "criterion": "IBIS-I trial therapy",
                    "requirements": [
                        {
                            "requirement_type": "off therapy duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior or concurrent raloxifene use lasting more than 6 months unless treatment was completed more than 5 years ago.",
            "criterions": [
                {
                    "exact_snippets": "No prior or concurrent raloxifene use lasting more than 6 months",
                    "criterion": "raloxifene use duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unless treatment was completed more than 5 years ago",
                    "criterion": "raloxifene treatment completion",
                    "requirements": [
                        {
                            "requirement_type": "completion time",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other prior or concurrent selective estrogen-receptor modulator use lasting more than 6 months unless treatment was completed more than 5 years ago",
            "criterions": [
                {
                    "exact_snippets": "No other prior or concurrent selective estrogen-receptor modulator use lasting more than 6 months",
                    "criterion": "selective estrogen-receptor modulator use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unless treatment was completed more than 5 years ago",
                    "criterion": "completion of treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent systemic estrogen-based hormone replacement therapy, including vaginal estrogen preparations",
            "criterions": [
                {
                    "exact_snippets": "No concurrent systemic estrogen-based hormone replacement therapy",
                    "criterion": "systemic estrogen-based hormone replacement therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No concurrent ... vaginal estrogen preparations",
                    "criterion": "vaginal estrogen preparations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "Radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Surgery",
            "criterions": [
                {
                    "exact_snippets": "Surgery",
                    "criterion": "surgery",
                    "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 prior mastectomy",
            "criterions": [
                {
                    "exact_snippets": "No prior mastectomy",
                    "criterion": "mastectomy",
                    "requirements": [
                        {
                            "requirement_type": "prior occurrence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No planned prophylactic mastectomy",
            "criterions": [
                {
                    "exact_snippets": "No planned prophylactic mastectomy",
                    "criterion": "prophylactic mastectomy",
                    "requirements": [
                        {
                            "requirement_type": "planned",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 3 months since prior unapproved or experimental agents",
            "criterions": [
                {
                    "exact_snippets": "At least 3 months since prior unapproved or experimental agents",
                    "criterion": "time since prior unapproved or experimental agents",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent anticoagulants",
            "criterions": [
                {
                    "exact_snippets": "No concurrent anticoagulants",
                    "criterion": "concurrent anticoagulants",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "Other",
            "criterions": []
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "Other",
            "criterions": []
        }
    ]
}