{
    "info": {
        "nct_id": "NCT03006172",
        "official_title": "A Phase I, Open-Label, Dose-Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0077 as a Single Agent in Patients With Locally Advanced or Metastatic PIK3CA-Mutant Solid Tumors and in Combination With Endocrine and Targeted Therapies in Patients With Locally Advanced or Metastatic PIK3CA-Mutant Breast Cancer",
        "inclusion_criteria": "* Evaluable or measurable disease per RECIST, Version 1.1 (measurable disease only for Arm D)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Life expectancy of greater than or equal to (>=) 12 weeks\n* Adequate hematologic and organ function, including blood counts, liver and kidney function\n\nStage I Arm A (Inavolisib):\n\n- Locally advanced, recurrent, or metastatic, PIK3CA mutant, incurable solid tumor malignancy, including breast cancer\n\nStages I and II, Arms B and C:\n\n- Postmenopausal female participants with locally advanced or metastatic PIK3CA-mutant HR+/HER2- breast cancer\n\nStage II, Arms D, E, or F:\n\n- Female participants with locally advanced or metastatic PIK3CA-mutant HR+/HER2- breast cancer\n\nStage II Arm D:\n\n- Prior treatment with CDK4/6 inhibitor\n\nStage II Arm G:\n\n* Female participants with locally advanced or metastatic PIK3CA-mutant HER2+ breast cancer\n* Left ventricular ejection fraction 50% or greater\n\nStages I and II:\n\n- All participants must provide tumor tissue from the primary or metastatic tumor site obtained from a prior or new biopsy or surgical procedure for detection of PIK3CA mutation by central laboratory test.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Metaplastic breast cancer\n* History of leptomeningeal disease\n* Type 1 or 2 diabetes requiring anti-hyperglycemic medication\n* Inability or unwillingness to swallow pills\n* Malabsorption syndrome or other condition that would interfere with enteral absorption\n* Known and untreated, or active central nervous system metastases\n* Uncontrolled pleural effusion or ascites\n* Any active infection that could impact patient safety or serious infection requiring intravenous antibiotics\n* History of other malignancy within 5 years, except for treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer\n* History of or active ventricular dysrhythmias or congestive heart failure requiring medication or symptomatic coronary heart disease\n* Congenital long QT syndrome, prolonged QT interval, or family history of sudden unexplained death or long QT syndrome\n\nStage II Arms B, C, D, and E only:\n\n* Prior treatment with >1 chemotherapy regimen for metastatic disease\n* Prior treatment with PI3K inhibitor\n* History of significant toxicity related to mTOR inhibitor requiring treatment discontinuation\n\nStage II Arms B and E only:\n\n- Prior CDK4/6 inhibitor treatment\n\nStage II Arm G only:\n\n* Current uncontrolled hypertension or unstable angina\n* History of congestive heart failure, serious cardiac arrhythmia, or recent myocardial infarction\n* Prior ejection fraction decrease on trastuzumab\n* Prior cumulative doxorubicin greater than 360 mg/m2\n* Symptomatic active lung disease\n* History of significant toxicity related to trastuzumab and/or pertuzumab requiring discontinuation of treatment",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Evaluable or measurable disease per RECIST, Version 1.1 (measurable disease only for Arm D)",
                "criterions": [
                    {
                        "exact_snippets": "Evaluable or measurable disease per RECIST, Version 1.1",
                        "criterion": "disease status",
                        "requirement": {
                            "requirement_type": "evaluation method",
                            "expected_value": "RECIST, Version 1.1"
                        }
                    },
                    {
                        "exact_snippets": "Evaluable or measurable disease per RECIST, Version 1.1",
                        "criterion": "disease status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "evaluable",
                                "measurable"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "measurable disease only for Arm D",
                        "criterion": "disease status for Arm D",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "measurable"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "measurable disease only for Arm D",
                    "criterion": "disease status for Arm D",
                    "requirement": {
                        "requirement_type": "status",
                        "expected_value": "measurable"
                    }
                },
                "then_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "Evaluable or measurable disease per RECIST, Version 1.1",
                            "criterion": "disease status",
                            "requirement": {
                                "requirement_type": "evaluation method",
                                "expected_value": "RECIST, Version 1.1"
                            }
                        },
                        {
                            "exact_snippets": "Evaluable or measurable disease per RECIST, Version 1.1",
                            "criterion": "disease status",
                            "requirement": {
                                "requirement_type": "status",
                                "expected_value": "measurable"
                            }
                        }
                    ]
                },
                "else_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "Evaluable or measurable disease per RECIST, Version 1.1",
                            "criterion": "disease status",
                            "requirement": {
                                "requirement_type": "evaluation method",
                                "expected_value": "RECIST, Version 1.1"
                            }
                        },
                        {
                            "exact_snippets": "Evaluable or measurable disease per RECIST, Version 1.1",
                            "criterion": "disease status",
                            "requirement": {
                                "requirement_type": "status",
                                "expected_value": [
                                    "evaluable",
                                    "measurable"
                                ]
                            }
                        }
                    ]
                }
            }
        },
        {
            "identified_line": {
                "line": "* Life expectancy of greater than or equal to (>=) 12 weeks",
                "criterions": [
                    {
                        "exact_snippets": "Life expectancy of greater than or equal to (>=) 12 weeks",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Life expectancy of greater than or equal to (>=) 12 weeks",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adequate hematologic and organ function, including blood counts, liver and kidney function",
                "criterions": [
                    {
                        "exact_snippets": "Adequate hematologic ... blood counts",
                        "criterion": "hematologic function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... organ function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "blood counts",
                        "criterion": "blood counts",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "liver ... function",
                        "criterion": "liver function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "kidney function",
                        "criterion": "kidney function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Adequate hematologic ... blood counts",
                                "criterion": "hematologic function",
                                "requirement": {
                                    "requirement_type": "adequacy",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "blood counts",
                                "criterion": "blood counts",
                                "requirement": {
                                    "requirement_type": "adequacy",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Adequate ... organ function",
                                "criterion": "organ function",
                                "requirement": {
                                    "requirement_type": "adequacy",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "liver ... function",
                                "criterion": "liver function",
                                "requirement": {
                                    "requirement_type": "adequacy",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "kidney function",
                                "criterion": "kidney function",
                                "requirement": {
                                    "requirement_type": "adequacy",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Stage I Arm A (Inavolisib):",
                "criterions": [
                    {
                        "exact_snippets": "Stage I",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "I"
                        }
                    },
                    {
                        "exact_snippets": "Arm A (Inavolisib)",
                        "criterion": "treatment arm",
                        "requirement": {
                            "requirement_type": "assignment",
                            "expected_value": "Arm A"
                        }
                    },
                    {
                        "exact_snippets": "Arm A (Inavolisib)",
                        "criterion": "treatment arm",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "Inavolisib"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Stage I",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "I"
                        }
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Arm A (Inavolisib)",
                                "criterion": "treatment arm",
                                "requirement": {
                                    "requirement_type": "assignment",
                                    "expected_value": "Arm A"
                                }
                            },
                            {
                                "exact_snippets": "Arm A (Inavolisib)",
                                "criterion": "treatment arm",
                                "requirement": {
                                    "requirement_type": "treatment",
                                    "expected_value": "Inavolisib"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "- Locally advanced, recurrent, or metastatic, PIK3CA mutant, incurable solid tumor malignancy, including breast cancer",
                "criterions": [
                    {
                        "exact_snippets": "Locally advanced, recurrent, or metastatic",
                        "criterion": "tumor stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "recurrent",
                                "metastatic"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "PIK3CA mutant",
                        "criterion": "PIK3CA mutation",
                        "requirement": {
                            "requirement_type": "mutation status",
                            "expected_value": "mutant"
                        }
                    },
                    {
                        "exact_snippets": "incurable solid tumor malignancy",
                        "criterion": "tumor curability",
                        "requirement": {
                            "requirement_type": "curability",
                            "expected_value": "incurable"
                        }
                    },
                    {
                        "exact_snippets": "solid tumor malignancy",
                        "criterion": "tumor type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "solid tumor"
                        }
                    },
                    {
                        "exact_snippets": "including breast cancer",
                        "criterion": "cancer type",
                        "requirement": {
                            "requirement_type": "specific type",
                            "expected_value": "breast cancer"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "and_criteria": [
                                                    {
                                                        "exact_snippets": "Locally advanced, recurrent, or metastatic",
                                                        "criterion": "tumor stage",
                                                        "requirement": {
                                                            "requirement_type": "stage",
                                                            "expected_value": [
                                                                "locally advanced",
                                                                "recurrent",
                                                                "metastatic"
                                                            ]
                                                        }
                                                    },
                                                    {
                                                        "exact_snippets": "PIK3CA mutant",
                                                        "criterion": "PIK3CA mutation",
                                                        "requirement": {
                                                            "requirement_type": "mutation status",
                                                            "expected_value": "mutant"
                                                        }
                                                    }
                                                ]
                                            },
                                            {
                                                "exact_snippets": "incurable solid tumor malignancy",
                                                "criterion": "tumor curability",
                                                "requirement": {
                                                    "requirement_type": "curability",
                                                    "expected_value": "incurable"
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "solid tumor malignancy",
                                        "criterion": "tumor type",
                                        "requirement": {
                                            "requirement_type": "type",
                                            "expected_value": "solid tumor"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "including breast cancer",
                                "criterion": "cancer type",
                                "requirement": {
                                    "requirement_type": "specific type",
                                    "expected_value": "breast cancer"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Stages I and II, Arms B and C:",
                "criterions": [
                    {
                        "exact_snippets": "Stages I and II",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "I",
                                "II"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Arms B and C",
                        "criterion": "trial arm",
                        "requirement": {
                            "requirement_type": "arm",
                            "expected_value": [
                                "B",
                                "C"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Stages I and II",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "I",
                                "II"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Arms B and C",
                        "criterion": "trial arm",
                        "requirement": {
                            "requirement_type": "arm",
                            "expected_value": [
                                "B",
                                "C"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "- Postmenopausal female participants with locally advanced or metastatic PIK3CA-mutant HR+/HER2- breast cancer",
                "criterions": [
                    {
                        "exact_snippets": "Postmenopausal female participants",
                        "criterion": "menopausal status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "postmenopausal"
                        }
                    },
                    {
                        "exact_snippets": "female participants",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "locally advanced or metastatic",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "PIK3CA-mutant",
                        "criterion": "PIK3CA mutation",
                        "requirement": {
                            "requirement_type": "mutation status",
                            "expected_value": "mutant"
                        }
                    },
                    {
                        "exact_snippets": "HR+/HER2- breast cancer",
                        "criterion": "breast cancer subtype",
                        "requirement": {
                            "requirement_type": "subtype",
                            "expected_value": "HR+/HER2-"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Postmenopausal female participants",
                                "criterion": "menopausal status",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": "postmenopausal"
                                }
                            },
                            {
                                "exact_snippets": "female participants",
                                "criterion": "gender",
                                "requirement": {
                                    "requirement_type": "gender",
                                    "expected_value": "female"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "locally advanced or metastatic",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "PIK3CA-mutant",
                        "criterion": "PIK3CA mutation",
                        "requirement": {
                            "requirement_type": "mutation status",
                            "expected_value": "mutant"
                        }
                    },
                    {
                        "exact_snippets": "HR+/HER2- breast cancer",
                        "criterion": "breast cancer subtype",
                        "requirement": {
                            "requirement_type": "subtype",
                            "expected_value": "HR+/HER2-"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Stage II, Arms D, E, or F:",
                "criterions": [
                    {
                        "exact_snippets": "Stage II",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "II"
                        }
                    },
                    {
                        "exact_snippets": "Arms D, E, or F",
                        "criterion": "treatment arm",
                        "requirement": {
                            "requirement_type": "arm",
                            "expected_value": [
                                "D",
                                "E",
                                "F"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Stage II",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "II"
                        }
                    },
                    {
                        "exact_snippets": "Arms D, E, or F",
                        "criterion": "treatment arm",
                        "requirement": {
                            "requirement_type": "arm",
                            "expected_value": [
                                "D",
                                "E",
                                "F"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Stage II Arm D:",
                "criterions": [
                    {
                        "exact_snippets": "Stage II",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "II"
                        }
                    },
                    {
                        "exact_snippets": "Arm D",
                        "criterion": "treatment arm",
                        "requirement": {
                            "requirement_type": "assignment",
                            "expected_value": "D"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Stage II",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "II"
                        }
                    },
                    {
                        "exact_snippets": "Arm D",
                        "criterion": "treatment arm",
                        "requirement": {
                            "requirement_type": "assignment",
                            "expected_value": "D"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "- Prior treatment with CDK4/6 inhibitor",
                "criterions": [
                    {
                        "exact_snippets": "Prior treatment with CDK4/6 inhibitor",
                        "criterion": "CDK4/6 inhibitor treatment",
                        "requirement": {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Prior treatment with CDK4/6 inhibitor",
                        "criterion": "CDK4/6 inhibitor treatment",
                        "requirement": {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Left ventricular ejection fraction 50% or greater",
                "criterions": [
                    {
                        "exact_snippets": "Left ventricular ejection fraction 50% or greater",
                        "criterion": "left ventricular ejection fraction",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Left ventricular ejection fraction 50% or greater",
                        "criterion": "left ventricular ejection fraction",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Stages I and II:",
                "criterions": [
                    {
                        "exact_snippets": "Stages I and II",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "I",
                                "II"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Stages I and II",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "I",
                                "II"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "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",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "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": "Stage II Arm G:",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Metaplastic breast cancer",
                "criterions": [
                    {
                        "exact_snippets": "Metaplastic breast cancer",
                        "criterion": "metaplastic breast cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Metaplastic breast cancer",
                    "criterion": "metaplastic breast cancer",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* History of leptomeningeal disease",
                "criterions": [
                    {
                        "exact_snippets": "History of leptomeningeal disease",
                        "criterion": "leptomeningeal disease",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
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            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "History of leptomeningeal disease",
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                        "requirement_type": "history",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Inability or unwillingness to swallow pills",
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                    {
                        "exact_snippets": "Inability ... to swallow pills",
                        "criterion": "ability to swallow pills",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "unwillingness to swallow pills",
                        "criterion": "willingness to swallow pills",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Inability ... to swallow pills",
                                "criterion": "ability to swallow pills",
                                "requirement": {
                                    "requirement_type": "ability",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "unwillingness to swallow pills",
                                "criterion": "willingness to swallow pills",
                                "requirement": {
                                    "requirement_type": "willingness",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "unwillingness to swallow pills",
                        "criterion": "willingness to swallow pills",
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                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Malabsorption syndrome or other condition that would interfere with enteral absorption",
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                    {
                        "exact_snippets": "Malabsorption syndrome",
                        "criterion": "malabsorption syndrome",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "other condition that would interfere with enteral absorption",
                        "criterion": "condition interfering with enteral absorption",
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                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
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            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Malabsorption syndrome",
                        "criterion": "malabsorption syndrome",
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                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "other condition that would interfere with enteral absorption",
                        "criterion": "condition interfering with enteral absorption",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Uncontrolled pleural effusion or ascites",
                "criterions": [
                    {
                        "exact_snippets": "Uncontrolled pleural effusion",
                        "criterion": "pleural effusion",
                        "requirement": {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled ... ascites",
                        "criterion": "ascites",
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                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Uncontrolled pleural effusion",
                        "criterion": "pleural effusion",
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                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled ... ascites",
                        "criterion": "ascites",
                        "requirement": {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any active infection that could impact patient safety or serious infection requiring intravenous antibiotics",
                "criterions": [
                    {
                        "exact_snippets": "Any active infection",
                        "criterion": "active infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "serious infection requiring intravenous antibiotics",
                        "criterion": "serious infection",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "intravenous antibiotics"
                        }
                    }
                ]
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                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Any active infection",
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                                    "requirement_type": "presence",
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                                }
                            },
                            {
                                "exact_snippets": "Any active infection",
                                "criterion": "active infection",
                                "requirement": {
                                    "requirement_type": "impact on patient safety",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "serious infection requiring intravenous antibiotics",
                        "criterion": "serious infection",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "intravenous antibiotics"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of other malignancy within 5 years, except for treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer",
                "criterions": [
                    {
                        "exact_snippets": "History of other malignancy within 5 years",
                        "criterion": "history of other malignancy",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "except for treated carcinoma in situ of the cervix",
                        "criterion": "treated carcinoma in situ of the cervix",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "except for ... non-melanoma skin carcinoma",
                        "criterion": "non-melanoma skin carcinoma",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "except for ... Stage I uterine cancer",
                        "criterion": "Stage I uterine cancer",
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                            "requirement_type": "exclusion",
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                    }
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            "logical_structure": {
                "condition": {
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                    "criterion": "history of other malignancy",
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                        "requirement_type": "time frame",
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                            "operator": "<=",
                            "value": 5,
                            "unit": "years"
                        }
                    }
                },
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                        {
                            "not_criteria": {
                                "exact_snippets": "except for treated carcinoma in situ of the cervix",
                                "criterion": "treated carcinoma in situ of the cervix",
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                                    "requirement_type": "exclusion",
                                    "expected_value": true
                                }
                            }
                        },
                        {
                            "not_criteria": {
                                "exact_snippets": "except for ... non-melanoma skin carcinoma",
                                "criterion": "non-melanoma skin carcinoma",
                                "requirement": {
                                    "requirement_type": "exclusion",
                                    "expected_value": true
                                }
                            }
                        },
                        {
                            "not_criteria": {
                                "exact_snippets": "except for ... Stage I uterine cancer",
                                "criterion": "Stage I uterine cancer",
                                "requirement": {
                                    "requirement_type": "exclusion",
                                    "expected_value": true
                                }
                            }
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* History of or active ventricular dysrhythmias or congestive heart failure requiring medication or symptomatic coronary heart disease",
                "criterions": [
                    {
                        "exact_snippets": "History of or active ventricular dysrhythmias",
                        "criterion": "ventricular dysrhythmias",
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                            "requirement_type": "presence",
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                        }
                    },
                    {
                        "exact_snippets": "congestive heart failure requiring medication",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "medication requirement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "symptomatic coronary heart disease",
                        "criterion": "coronary heart disease",
                        "requirement": {
                            "requirement_type": "symptoms",
                            "expected_value": true
                        }
                    }
                ]
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                "or_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "History of or active ventricular dysrhythmias",
                                "criterion": "ventricular dysrhythmias",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "congestive heart failure requiring medication",
                                "criterion": "congestive heart failure",
                                "requirement": {
                                    "requirement_type": "medication requirement",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "symptomatic coronary heart disease",
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                            "requirement_type": "symptoms",
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                        }
                    }
                ]
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        },
        {
            "identified_line": {
                "line": "* Congenital long QT syndrome, prolonged QT interval, or family history of sudden unexplained death or long QT syndrome",
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                    {
                        "exact_snippets": "Congenital long QT syndrome",
                        "criterion": "congenital long QT syndrome",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "prolonged QT interval",
                        "criterion": "QT interval",
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                            "expected_value": "prolonged"
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                    },
                    {
                        "exact_snippets": "family history of sudden unexplained death",
                        "criterion": "family history of sudden unexplained death",
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                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "family history of ... long QT syndrome",
                        "criterion": "family history of long QT syndrome",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
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            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Congenital long QT syndrome",
                                "criterion": "congenital long QT syndrome",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "prolonged QT interval",
                                "criterion": "QT interval",
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                                    "requirement_type": "duration",
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                        ]
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                    {
                        "exact_snippets": "family history of sudden unexplained death",
                        "criterion": "family history of sudden unexplained death",
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                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "family history of ... long QT syndrome",
                        "criterion": "family history of long QT syndrome",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
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        },
        {
            "identified_line": {
                "line": "Stage II Arms B, C, D, and E only:",
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                    {
                        "exact_snippets": "Stage II",
                        "criterion": "cancer stage",
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                            "requirement_type": "stage",
                            "expected_value": "II"
                        }
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                    {
                        "exact_snippets": "Arms B, C, D, and E only",
                        "criterion": "trial arm",
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                            "requirement_type": "inclusion",
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                                "B",
                                "C",
                                "D",
                                "E"
                            ]
                        }
                    }
                ]
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            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Stage II",
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                            "requirement_type": "stage",
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                    {
                        "exact_snippets": "Arms B, C, D, and E only",
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                            "requirement_type": "inclusion",
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                                "B",
                                "C",
                                "D",
                                "E"
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                ]
            }
        },
        {
            "identified_line": {
                "line": "* Prior treatment with >1 chemotherapy regimen for metastatic disease",
                "criterions": [
                    {
                        "exact_snippets": "Prior treatment with >1 chemotherapy regimen for metastatic disease",
                        "criterion": "chemotherapy regimen for metastatic disease",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "N/A"
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                        }
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                ]
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            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Prior treatment with >1 chemotherapy regimen for metastatic disease",
                    "criterion": "chemotherapy regimen for metastatic disease",
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                        "requirement_type": "quantity",
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                            "operator": ">",
                            "value": 1,
                            "unit": "N/A"
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                    }
                }
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        },
        {
            "identified_line": {
                "line": "* Prior treatment with PI3K inhibitor",
                "criterions": [
                    {
                        "exact_snippets": "Prior treatment with PI3K inhibitor",
                        "criterion": "PI3K inhibitor treatment",
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                            "requirement_type": "prior treatment",
                            "expected_value": true
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            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Prior treatment with PI3K inhibitor",
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                        "requirement_type": "prior treatment",
                        "expected_value": true
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        {
            "identified_line": {
                "line": "* History of significant toxicity related to mTOR inhibitor requiring treatment discontinuation",
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                    {
                        "exact_snippets": "History of significant toxicity related to mTOR inhibitor requiring treatment discontinuation",
                        "criterion": "toxicity related to mTOR inhibitor",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
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                    },
                    {
                        "exact_snippets": "History of significant toxicity related to mTOR inhibitor requiring treatment discontinuation",
                        "criterion": "toxicity related to mTOR inhibitor",
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                            "requirement_type": "severity",
                            "expected_value": "significant"
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                    },
                    {
                        "exact_snippets": "History of significant toxicity related to mTOR inhibitor requiring treatment discontinuation",
                        "criterion": "toxicity related to mTOR inhibitor",
                        "requirement": {
                            "requirement_type": "consequence",
                            "expected_value": "treatment discontinuation"
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                    }
                ]
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                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of significant toxicity related to mTOR inhibitor requiring treatment discontinuation",
                                "criterion": "toxicity related to mTOR inhibitor",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "History of significant toxicity related to mTOR inhibitor requiring treatment discontinuation",
                                "criterion": "toxicity related to mTOR inhibitor",
                                "requirement": {
                                    "requirement_type": "severity",
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                            }
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                    {
                        "exact_snippets": "History of significant toxicity related to mTOR inhibitor requiring treatment discontinuation",
                        "criterion": "toxicity related to mTOR inhibitor",
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                            "requirement_type": "consequence",
                            "expected_value": "treatment discontinuation"
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                ]
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        },
        {
            "identified_line": {
                "line": "Stage II Arms B and E only:",
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                    {
                        "exact_snippets": "Stage II",
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                            "requirement_type": "stage",
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                    },
                    {
                        "exact_snippets": "Arms B and E only",
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                            "requirement_type": "inclusion",
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                                "B",
                                "E"
                            ]
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                ]
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            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "Stage II",
                            "criterion": "cancer stage",
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                                "requirement_type": "stage",
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                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "Arms B and E only",
                            "criterion": "trial arm",
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                                "requirement_type": "inclusion",
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                                    "B",
                                    "E"
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "- Prior CDK4/6 inhibitor treatment",
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                    {
                        "exact_snippets": "Prior CDK4/6 inhibitor treatment",
                        "criterion": "CDK4/6 inhibitor treatment",
                        "requirement": {
                            "requirement_type": "prior treatment",
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                    }
                ]
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            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Prior CDK4/6 inhibitor treatment",
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                        "requirement_type": "prior treatment",
                        "expected_value": true
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        {
            "identified_line": {
                "line": "Stage II Arm G only:",
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                    {
                        "exact_snippets": "Stage II",
                        "criterion": "cancer stage",
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                            "requirement_type": "stage",
                            "expected_value": "II"
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                    },
                    {
                        "exact_snippets": "Arm G only",
                        "criterion": "treatment arm",
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                            "requirement_type": "specific arm",
                            "expected_value": "G"
                        }
                    }
                ]
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            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Stage II",
                        "criterion": "cancer stage",
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                            "requirement_type": "stage",
                            "expected_value": "II"
                        }
                    },
                    {
                        "exact_snippets": "Arm G only",
                        "criterion": "treatment arm",
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                            "requirement_type": "specific arm",
                            "expected_value": "G"
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                    }
                ]
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        },
        {
            "identified_line": {
                "line": "* Current uncontrolled hypertension or unstable angina",
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                    {
                        "exact_snippets": "Current uncontrolled hypertension",
                        "criterion": "hypertension",
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                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
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                    },
                    {
                        "exact_snippets": "unstable angina",
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                            "requirement_type": "stability",
                            "expected_value": "unstable"
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            "logical_structure": {
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                    {
                        "exact_snippets": "Current uncontrolled hypertension",
                        "criterion": "hypertension",
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                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    },
                    {
                        "exact_snippets": "unstable angina",
                        "criterion": "angina",
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                            "requirement_type": "stability",
                            "expected_value": "unstable"
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                    }
                ]
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        },
        {
            "identified_line": {
                "line": "* History of congestive heart failure, serious cardiac arrhythmia, or recent myocardial infarction",
                "criterions": [
                    {
                        "exact_snippets": "History of congestive heart failure",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "serious cardiac arrhythmia",
                        "criterion": "cardiac arrhythmia",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    },
                    {
                        "exact_snippets": "recent myocardial infarction",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "recency",
                            "expected_value": "recent"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "History of congestive heart failure",
                        "criterion": "congestive heart failure",
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                            "requirement_type": "history",
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                        }
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                    {
                        "exact_snippets": "serious cardiac arrhythmia",
                        "criterion": "cardiac arrhythmia",
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                            "requirement_type": "severity",
                            "expected_value": "serious"
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                    },
                    {
                        "exact_snippets": "recent myocardial infarction",
                        "criterion": "myocardial infarction",
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                            "requirement_type": "recency",
                            "expected_value": "recent"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Prior ejection fraction decrease on trastuzumab",
                "criterions": [
                    {
                        "exact_snippets": "Prior ejection fraction decrease on trastuzumab",
                        "criterion": "ejection fraction",
                        "requirement": {
                            "requirement_type": "prior decrease",
                            "expected_value": true
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                    },
                    {
                        "exact_snippets": "Prior ejection fraction decrease on trastuzumab",
                        "criterion": "ejection fraction",
                        "requirement": {
                            "requirement_type": "medication",
                            "expected_value": "trastuzumab"
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            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Prior ejection fraction decrease on trastuzumab",
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                            "requirement_type": "prior decrease",
                            "expected_value": true
                        }
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                    {
                        "exact_snippets": "Prior ejection fraction decrease on trastuzumab",
                        "criterion": "ejection fraction",
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                            "requirement_type": "medication",
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                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Prior cumulative doxorubicin greater than 360 mg/m2",
                "criterions": [
                    {
                        "exact_snippets": "Prior cumulative doxorubicin greater than 360 mg/m2",
                        "criterion": "cumulative doxorubicin",
                        "requirement": {
                            "requirement_type": "amount",
                            "expected_value": {
                                "operator": ">",
                                "value": 360,
                                "unit": "mg/m2"
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}