{
    "info": {
        "nct_id": "NCT02400476",
        "official_title": "An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide",
        "inclusion_criteria": "* Age ≥18; male or female\n* Early breast cancer (stage I-3c)\n* Documented HER2+ tumor: HER2 immunohistochemistry (IHC) 3+ or ISH+\n* Prior course of adjuvant trastuzumab given >2 weeks and ≤1 year from enrollment\n* No evidence of local/regional recurrence or metastatic disease\n* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n* Male patients with female partners of childbearing potential must agree and commit to use a condom and women of childbearing potential must not be pregnant and must agree and commit to the use of a highly effective non-hormonal method of contraception\n* Left ventricular ejection fraction (LVEF) ≥50% measured by multiple-gated acquisition scan (MUGA) or ECHO\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Major surgery < 30 days\n* Chemotherapy, investigational agents, other cancer therapy (except hormonal therapy) < 14 days\n* Corrected QT Interval (QTc) >0.450 seconds (males) or >0.470 (females) or other active cardiac disease\n* Significant chronic GI disorder with diarrhea as a major symptom\n* Active, unresolved infections\n* Currently pregnant or breast-feeding",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Age ≥18; male or female",
                "criterions": [
                    {
                        "exact_snippets": "Age ≥18",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "male or female",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "gender",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age ≥18",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "male or female",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "gender",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Early breast cancer (stage I-3c)",
                "criterions": [
                    {
                        "exact_snippets": "Early breast cancer (stage I-3c)",
                        "criterion": "breast cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "c"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Early breast cancer (stage I-3c)",
                        "criterion": "breast cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "c"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Documented HER2+ tumor: HER2 immunohistochemistry (IHC) 3+ or ISH+",
                "criterions": [
                    {
                        "exact_snippets": "Documented HER2+ tumor: HER2 immunohistochemistry (IHC) 3+",
                        "criterion": "HER2 immunohistochemistry (IHC)",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "3+"
                        }
                    },
                    {
                        "exact_snippets": "Documented HER2+ tumor: ... ISH+",
                        "criterion": "ISH",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Documented HER2+ tumor: HER2 immunohistochemistry (IHC) 3+",
                        "criterion": "HER2 immunohistochemistry (IHC)",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "3+"
                        }
                    },
                    {
                        "exact_snippets": "Documented HER2+ tumor: ... ISH+",
                        "criterion": "ISH",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Prior course of adjuvant trastuzumab given >2 weeks and ≤1 year from enrollment",
                "criterions": [
                    {
                        "exact_snippets": "Prior course of adjuvant trastuzumab",
                        "criterion": "adjuvant trastuzumab",
                        "requirement": {
                            "requirement_type": "prior course",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "given >2 weeks and ≤1 year from enrollment",
                        "criterion": "time since adjuvant trastuzumab",
                        "requirement": {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 2,
                                        "unit": "weeks"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "year"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Prior course of adjuvant trastuzumab",
                        "criterion": "adjuvant trastuzumab",
                        "requirement": {
                            "requirement_type": "prior course",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "given >2 weeks and ≤1 year from enrollment",
                        "criterion": "time since adjuvant trastuzumab",
                        "requirement": {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 2,
                                        "unit": "weeks"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "year"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No evidence of local/regional recurrence or metastatic disease",
                "criterions": [
                    {
                        "exact_snippets": "No evidence of local/regional recurrence",
                        "criterion": "local/regional recurrence",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No evidence of ... metastatic disease",
                        "criterion": "metastatic disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No evidence of local/regional recurrence",
                        "criterion": "local/regional recurrence",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No evidence of ... metastatic disease",
                        "criterion": "metastatic disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) status of 0 or 1",
                        "criterion": "ECOG status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) status of 0 or 1",
                        "criterion": "ECOG status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Left ventricular ejection fraction (LVEF) ≥50% measured by multiple-gated acquisition scan (MUGA) or ECHO",
                "criterions": [
                    {
                        "exact_snippets": "Left ventricular ejection fraction (LVEF) ≥50%",
                        "criterion": "left ventricular ejection fraction (LVEF)",
                        "requirement": {
                            "requirement_type": "measurement",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Left ventricular ejection fraction (LVEF) ≥50%",
                        "criterion": "left ventricular ejection fraction (LVEF)",
                        "requirement": {
                            "requirement_type": "measurement",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Left ventricular ejection fraction (LVEF) ≥50%",
                                "criterion": "measurement method",
                                "requirement": {
                                    "requirement_type": "method",
                                    "expected_value": "MUGA"
                                }
                            },
                            {
                                "exact_snippets": "Left ventricular ejection fraction (LVEF) ≥50%",
                                "criterion": "measurement method",
                                "requirement": {
                                    "requirement_type": "method",
                                    "expected_value": "ECHO"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "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": {
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                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
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                            "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": "* Male patients with female partners of childbearing potential must agree and commit to use a condom and women of childbearing potential must not be pregnant and must agree and commit to the use of a highly effective non-hormonal method of contraception",
                "criterions": [
                    {
                        "exact_snippets": "Male patients with female partners of childbearing potential must agree and commit to use a condom",
                        "criterion": "male patients with female partners of childbearing potential",
                        "requirement": {
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                            "expected_value": "condom"
                        }
                    },
                    {
                        "exact_snippets": "women of childbearing potential must not be pregnant",
                        "criterion": "women of childbearing potential",
                        "requirement": {
                            "requirement_type": "pregnancy status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "women of childbearing potential must agree and commit to the use of a highly effective non-hormonal method of contraception",
                        "criterion": "women of childbearing potential",
                        "requirement": {
                            "requirement_type": "contraception method",
                            "expected_value": "highly effective non-hormonal"
                        }
                    }
                ]
            },
            "logical_structure": {
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                                "exact_snippets": "Male patients with female partners of childbearing potential must agree and commit to use a condom",
                                "criterion": "male patients with female partners of childbearing potential",
                                "requirement": {
                                    "requirement_type": "contraception method",
                                    "expected_value": "condom"
                                }
                            },
                            {
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                                    {
                                        "exact_snippets": "women of childbearing potential must not be pregnant",
                                        "criterion": "women of childbearing potential",
                                        "requirement": {
                                            "requirement_type": "pregnancy status",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "women of childbearing potential must agree and commit to the use of a highly effective non-hormonal method of contraception",
                                        "criterion": "women of childbearing potential",
                                        "requirement": {
                                            "requirement_type": "contraception method",
                                            "expected_value": "highly effective non-hormonal"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Major surgery < 30 days",
                "criterions": [
                    {
                        "exact_snippets": "Major surgery < 30 days",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    }
                ]
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            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Major surgery < 30 days",
                    "criterion": "major surgery",
                    "requirement": {
                        "requirement_type": "time since surgery",
                        "expected_value": {
                            "operator": "<",
                            "value": 30,
                            "unit": "days"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Chemotherapy, investigational agents, other cancer therapy (except hormonal therapy) < 14 days",
                "criterions": [
                    {
                        "exact_snippets": "Chemotherapy ... < 14 days",
                        "criterion": "chemotherapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
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                                "unit": "days"
                            }
                        }
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                    {
                        "exact_snippets": "investigational agents ... < 14 days",
                        "criterion": "investigational agents",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "other cancer therapy (except hormonal therapy) < 14 days",
                        "criterion": "other cancer therapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Chemotherapy ... < 14 days",
                                "criterion": "chemotherapy",
                                "requirement": {
                                    "requirement_type": "time since last treatment",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 14,
                                        "unit": "days"
                                    }
                                }
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                        ]
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                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "investigational agents ... < 14 days",
                                "criterion": "investigational agents",
                                "requirement": {
                                    "requirement_type": "time since last treatment",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 14,
                                        "unit": "days"
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                                }
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                        ]
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                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "other cancer therapy (except hormonal therapy) < 14 days",
                                "criterion": "other cancer therapy",
                                "requirement": {
                                    "requirement_type": "time since last treatment",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 14,
                                        "unit": "days"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Significant chronic GI disorder with diarrhea as a major symptom",
                "criterions": [
                    {
                        "exact_snippets": "Significant chronic GI disorder",
                        "criterion": "chronic GI disorder",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    },
                    {
                        "exact_snippets": "diarrhea as a major symptom",
                        "criterion": "diarrhea",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "major symptom"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Significant chronic GI disorder",
                        "criterion": "chronic GI disorder",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    },
                    {
                        "exact_snippets": "diarrhea as a major symptom",
                        "criterion": "diarrhea",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "major symptom"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Active, unresolved infections",
                "criterions": [
                    {
                        "exact_snippets": "Active, unresolved infections",
                        "criterion": "infections",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "Active, unresolved infections",
                        "criterion": "infections",
                        "requirement": {
                            "requirement_type": "resolution",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
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                        "exact_snippets": "Active, unresolved infections",
                        "criterion": "infections",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "Active, unresolved infections",
                        "criterion": "infections",
                        "requirement": {
                            "requirement_type": "resolution",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Currently pregnant or breast-feeding",
                "criterions": [
                    {
                        "exact_snippets": "Currently pregnant",
                        "criterion": "pregnancy status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "pregnant"
                        }
                    },
                    {
                        "exact_snippets": "breast-feeding",
                        "criterion": "breastfeeding status",
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                            "requirement_type": "status",
                            "expected_value": "breast-feeding"
                        }
                    }
                ]
            },
            "logical_structure": {
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                        "exact_snippets": "Currently pregnant",
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                        }
                    },
                    {
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                            "requirement_type": "status",
                            "expected_value": "breast-feeding"
                        }
                    }
                ]
            }
        },
        {
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                "line": "* Corrected QT Interval (QTc) >0.450 seconds (males) or >0.470 (females) or other active cardiac disease",
                "criterions": [
                    {
                        "exact_snippets": "Corrected QT Interval (QTc) >0.450 seconds (males)",
                        "criterion": "Corrected QT Interval (QTc)",
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                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 0.45,
                                "unit": "seconds"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Corrected QT Interval (QTc) >0.470 (females)",
                        "criterion": "Corrected QT Interval (QTc)",
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                            "requirement_type": "value",
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                                "operator": ">",
                                "value": 0.47,
                                "unit": "seconds"
                            }
                        }
                    },
                    {
                        "exact_snippets": "other active cardiac disease",
                        "criterion": "active cardiac disease",
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                            "requirement_type": "presence",
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                        }
                    }
                ]
            },
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                                "exact_snippets": "Corrected QT Interval (QTc) >0.450 seconds (males)",
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                                    "requirement_type": "value",
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                                        "unit": "seconds"
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                            },
                            {
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                                    "requirement_type": "value",
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                                        "value": 0.47,
                                        "unit": "seconds"
                                    }
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                        }
                    }
                ]
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        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}