{
    "info": {
        "nct_id": "NCT02278120",
        "official_title": "A Phase III Randomized, Double-blind, Placebo-controlled Study of LEE011 or Placebo in Combination With Tamoxifen and Goserelin or a Non-steroidal Aromatase Inhibitor (NSAI) and Goserelin for the Treatment of Premenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 59 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Key inclusion criteria:\n\n* Patients had advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy\n* Patients were premenopausal or perimenopausal at the time of study entry\n* Patients who had received (neo) adjuvant therapy for breast cancer were eligible\n* Patients had a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer\n* Patients had HER2-negative breast cancer\n* Patients must have either had measurable disease or If no measurable disease was present, then at least one predominantly lytic bone lesion\n* Patients had an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Patients had adequate bone marrow and organ function\n\nKey exclusion criteria:\n\n* Patients who had received a prior CDK4/6 inhibitor\n* Patients were postmenopausal\n* Patients who currently had inflammatory breast cancer at screening.\n* Patients who had received any prior hormonal anti-cancer therapy for advanced breast cancer, except for ≤ 14 days of tamoxifen or NSAI ± goserelin for advanced breast cancer prior to randomization.\n* Patients had a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated basal cell skin carcinoma, squamous cell skin carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.\n* Patients with CNS metastases.\n* Patients had active cardiac disease or a history of cardiac dysfunction\n* Patients were currently using other antineoplastic agents\n* Patients were pregnant or nursing or physiologically capable of becoming pregnant and not using highly effective contraception."
    },
    "inclusion_lines": [
        {
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                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
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                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must be FEMALE",
                "criterions": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
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                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be FEMALE",
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                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 59 Years",
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                    {
                        "exact_snippets": "maximum age of 59 Years",
                        "criterion": "age",
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                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 59,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
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                    {
                        "exact_snippets": "maximum age of 59 Years",
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                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 59,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
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                "line": "* Patients had advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy",
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                    {
                        "exact_snippets": "advanced (locoregionally recurrent or metastatic) breast cancer",
                        "criterion": "breast cancer",
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                            "requirement_type": "stage",
                            "expected_value": [
                                "advanced",
                                "locoregionally recurrent",
                                "metastatic"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "not amenable to curative therapy",
                        "criterion": "curative therapy",
                        "requirement": {
                            "requirement_type": "amenability",
                            "expected_value": false
                        }
                    }
                ]
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                "and_criteria": [
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                        "and_criteria": [
                            {
                                "exact_snippets": "advanced (locoregionally recurrent or metastatic) breast cancer",
                                "criterion": "breast cancer",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": [
                                        "advanced",
                                        "locoregionally recurrent",
                                        "metastatic"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "not amenable to curative therapy",
                                "criterion": "curative therapy",
                                "requirement": {
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                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients were premenopausal or perimenopausal at the time of study entry",
                "criterions": [
                    {
                        "exact_snippets": "Patients were premenopausal",
                        "criterion": "menopausal status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "premenopausal"
                        }
                    },
                    {
                        "exact_snippets": "or perimenopausal",
                        "criterion": "menopausal status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "perimenopausal"
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Patients were premenopausal",
                        "criterion": "menopausal status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "premenopausal"
                        }
                    },
                    {
                        "exact_snippets": "or perimenopausal",
                        "criterion": "menopausal status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "perimenopausal"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients who had received (neo) adjuvant therapy for breast cancer were eligible",
                "criterions": [
                    {
                        "exact_snippets": "Patients who had received (neo) adjuvant therapy for breast cancer",
                        "criterion": "(neo) adjuvant therapy for breast cancer",
                        "requirement": {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
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                        "exact_snippets": "Patients who had received (neo) adjuvant therapy for breast cancer",
                        "criterion": "(neo) adjuvant therapy for breast cancer",
                        "requirement": {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients had HER2-negative breast cancer",
                "criterions": [
                    {
                        "exact_snippets": "HER2-negative breast cancer",
                        "criterion": "HER2 status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "breast cancer",
                        "criterion": "cancer type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "breast cancer"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "HER2-negative breast cancer",
                        "criterion": "HER2 status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "breast cancer",
                        "criterion": "cancer type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "breast cancer"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must have either had measurable disease or If no measurable disease was present, then at least one predominantly lytic bone lesion",
                "criterions": [
                    {
                        "exact_snippets": "Patients must have either had measurable disease",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "If no measurable disease was present, then at least one predominantly lytic bone lesion",
                        "criterion": "predominantly lytic bone lesion",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "xor_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Patients must have either had measurable disease",
                                "criterion": "measurable disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "If no measurable disease was present, then at least one predominantly lytic bone lesion",
                                "criterion": "measurable disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "If no measurable disease was present, then at least one predominantly lytic bone lesion",
                                "criterion": "predominantly lytic bone lesion",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
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                        ]
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                ]
            }
        },
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                        "exact_snippets": "adequate bone marrow",
                        "criterion": "bone marrow function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "adequate ... organ function",
                        "criterion": "organ function",
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                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
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                        "exact_snippets": "adequate bone marrow",
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                        }
                    },
                    {
                        "exact_snippets": "adequate ... organ function",
                        "criterion": "organ function",
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                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
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                        "exact_snippets": "Patients who had received a prior CDK4/6 inhibitor",
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        },
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                        "exact_snippets": "postmenopausal",
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            "identified_line": {
                "line": "* Patients who currently had inflammatory breast cancer at screening.",
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                        "exact_snippets": "inflammatory breast cancer at screening",
                        "criterion": "inflammatory breast cancer",
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                            "expected_value": true
                        }
                    }
                ]
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            "logical_structure": {
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                        "exact_snippets": "inflammatory breast cancer at screening",
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                            "expected_value": true
                        }
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                ]
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        },
        {
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                "line": "* Patients who had received any prior hormonal anti-cancer therapy for advanced breast cancer, except for ≤ 14 days of tamoxifen or NSAI ± goserelin for advanced breast cancer prior to randomization.",
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                        "exact_snippets": "Patients who had received any prior hormonal anti-cancer therapy for advanced breast cancer",
                        "criterion": "prior hormonal anti-cancer therapy for advanced breast cancer",
                        "requirement": {
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                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "except for ≤ 14 days of tamoxifen or NSAI ± goserelin for advanced breast cancer prior to randomization",
                        "criterion": "duration of tamoxifen or NSAI ± goserelin for advanced breast cancer",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
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                        "expected_value": true
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                        "criterion": "duration of tamoxifen or NSAI ± goserelin for advanced breast cancer",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
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                                "unit": "days"
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                        }
                    }
                },
                "else_criteria": null
            }
        },
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                "line": "* Patients with CNS metastases.",
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                        }
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                        "criterion": "CNS metastases",
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                    }
                ]
            }
        },
        {
            "identified_line": {
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                        "exact_snippets": "active cardiac disease",
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                            "expected_value": true
                        }
                    },
                    {
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                        }
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                ]
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                        "exact_snippets": "history of cardiac dysfunction",
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        },
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            "identified_line": {
                "line": "* Patients were currently using other antineoplastic agents",
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                        "exact_snippets": "currently using other antineoplastic agents",
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                        "requirement": {
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                        }
                    }
                ]
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            "logical_structure": {
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                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Patients were pregnant or nursing or physiologically capable of becoming pregnant and not using highly effective contraception.",
                "criterions": [
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                        "exact_snippets": "Patients were pregnant",
                        "criterion": "pregnancy status",
                        "requirement": {
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                        }
                    },
                    {
                        "exact_snippets": "nursing",
                        "criterion": "nursing status",
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                            "requirement_type": "presence",
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                        }
                    },
                    {
                        "exact_snippets": "physiologically capable of becoming pregnant",
                        "criterion": "physiological capability of becoming pregnant",
                        "requirement": {
                            "requirement_type": "capability",
                            "expected_value": false
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                    },
                    {
                        "exact_snippets": "not using highly effective contraception",
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                                "exact_snippets": "Patients were pregnant",
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                                "exact_snippets": "physiologically capable of becoming pregnant",
                                "criterion": "physiological capability of becoming pregnant",
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                                }
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                            {
                                "exact_snippets": "not using highly effective contraception",
                                "criterion": "use of highly effective contraception",
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            }
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                "line": "Key exclusion criteria:",
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            }
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    ],
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    "failed_exclusion": [],
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        {
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                "line": "* Patients had a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer",
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                    {
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                        }
                    },
                    {
                        "exact_snippets": "progesterone receptor positive",
                        "criterion": "progesterone receptor status",
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                        }
                    },
                    {
                        "exact_snippets": "breast cancer",
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                    }
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                                        "criterion": "estrogen receptor status",
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                                        }
                                    },
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                                            "expected_value": "cytologically"
                                        }
                                    },
                                    {
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                                            "requirement_type": "status",
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                                        }
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                                    {
                                        "exact_snippets": "breast cancer",
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                                            "expected_value": "breast cancer"
                                        }
                                    }
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                            {
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                                        "requirement": {
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                                            "expected_value": "histologically"
                                        }
                                    },
                                    {
                                        "exact_snippets": "progesterone receptor positive",
                                        "criterion": "progesterone receptor status",
                                        "requirement": {
                                            "requirement_type": "status",
                                            "expected_value": "positive"
                                        }
                                    },
                                    {
                                        "exact_snippets": "breast cancer",
                                        "criterion": "cancer type",
                                        "requirement": {
                                            "requirement_type": "type",
                                            "expected_value": "breast cancer"
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "histologically and/or cytologically confirmed diagnosis",
                                        "criterion": "diagnosis confirmation method",
                                        "requirement": {
                                            "requirement_type": "method",
                                            "expected_value": "cytologically"
                                        }
                                    },
                                    {
                                        "exact_snippets": "progesterone receptor positive",
                                        "criterion": "progesterone receptor status",
                                        "requirement": {
                                            "requirement_type": "status",
                                            "expected_value": "positive"
                                        }
                                    },
                                    {
                                        "exact_snippets": "breast cancer",
                                        "criterion": "cancer type",
                                        "requirement": {
                                            "requirement_type": "type",
                                            "expected_value": "breast cancer"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients had an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "0"
                        }
                    },
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "1"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients had a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated basal cell skin carcinoma, squamous cell skin carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.",
                "criterions": [
                    {
                        "exact_snippets": "concurrent malignancy",
                        "criterion": "concurrent malignancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "malignancy within 3 years of randomization",
                        "criterion": "malignancy within 3 years",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "adequately treated basal cell skin carcinoma",
                        "criterion": "adequately treated basal cell skin carcinoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "squamous cell skin carcinoma",
                        "criterion": "squamous cell skin carcinoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "non-melanomatous skin cancer",
                        "criterion": "non-melanomatous skin cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "curatively resected cervical cancer",
                        "criterion": "curatively resected cervical cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "or_criteria": [
                        {
                            "and_criteria": [
                                {
                                    "exact_snippets": "concurrent malignancy",
                                    "criterion": "concurrent malignancy",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "exact_snippets": "adequately treated basal cell skin carcinoma",
                                        "criterion": "adequately treated basal cell skin carcinoma",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "exact_snippets": "squamous cell skin carcinoma",
                                        "criterion": "squamous cell skin carcinoma",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "exact_snippets": "non-melanomatous skin cancer",
                                        "criterion": "non-melanomatous skin cancer",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "exact_snippets": "curatively resected cervical cancer",
                                        "criterion": "curatively resected cervical cancer",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                }
                            ]
                        },
                        {
                            "and_criteria": [
                                {
                                    "exact_snippets": "malignancy within 3 years of randomization",
                                    "criterion": "malignancy within 3 years",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "exact_snippets": "adequately treated basal cell skin carcinoma",
                                        "criterion": "adequately treated basal cell skin carcinoma",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "exact_snippets": "squamous cell skin carcinoma",
                                        "criterion": "squamous cell skin carcinoma",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "exact_snippets": "non-melanomatous skin cancer",
                                        "criterion": "non-melanomatous skin cancer",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "exact_snippets": "curatively resected cervical cancer",
                                        "criterion": "curatively resected cervical cancer",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                }
                            ]
                        }
                    ]
                },
                "then_criteria": {
                    "exact_snippets": "concurrent malignancy",
                    "criterion": "concurrent malignancy",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                },
                "else_criteria": null
            }
        }
    ]
}