{
    "info": {
        "nct_id": "NCT01772472",
        "official_title": "A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With HER2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy",
        "inclusion_criteria": "* Adult patient, >/= 18 years of age\n* HER2-positive breast cancer\n* Histologically confirmed invasive breast carcinoma\n* Clinical stage T1-4/N0-3/M0 at presentation (patients with T1a/bN0 tumors will not be eligible)\n* Completion of preoperative systemic chemotherapy and HER2-directed treatment consisting of at least 6 cycles of chemotherapy with a total duration of at least 16 weeks, including at least 9 weeks of trastuzumab and at least 9 weeks of taxane-based therapy\n* Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes as specified in protocol\n* Pathological evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy\n* An interval of no more than 12 weeks between the date of surgery and the date of randomization\n* Known hormone-receptor status\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Adequate hematologic, renal and liver function\n* Screening Left ventricular ejection fraction (LVEF) >/= 50% on echocardiogram (ECHO) or multiple-gated acquisition (MUGA) after receiving neoadjuvant chemotherapy and no decrease in LVEF by more than 15% absolute points from the pre-chemotherapy LVEF. Or, if pre-chemotherapy LVEF was not assessed, the screening LVEF must be >/= 55% after completion of neoadjuvant chemotherapy.\n* For women who are not postmenopausal or surgically sterile: agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 7 months after the last dose of study drug\n* Documentation of hepatitis B virus and hepatitis C virus serology is required\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Stage IV (metastatic) breast cancer\n* History of any prior (ipsi- or contralateral breast cancer except lobular carcinoma in situ\n* Evidence of clinically evident gross residual or recurrent disease following preoperative therapy and surgery\n* Progressive disease during preoperative systemic therapy\n* Treatment with any anti-cancer investigational drug within 28 days prior to commencing study treatment\n* History of other malignancy within the last 5 years except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other non-breast malignancies with a similar outcome to those mentioned above\n* Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons\n* Current NCI CTCAE (Version 4.0) Grade >/= 2 peripheral neuropathy\n* History of exposure to the following cumulative doses of anthracyclines: Doxorubicin > 240 mg/m2; Epirubicin or Liposomal Doxorubicin-Hydrochloride (Myocet®) > 480 mg/m2; For other anthracyclines, exposure equivalent to doxorubicin > 240 mg/m2\n* Cardiopulmonary dysfunction as defined by protocol\n* Prior treatment with trastuzumab emtansine\n* Current severe, uncontrolled systemic disease\n* Pregnant or lactating women\n* Any known active liver disease, e.g. due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis\n* Concurrent serious uncontrolled infections requiring treatment or known infection with HIV\n* History of intolerance, including Grade 3 to 4 infusion reaction or hypersensitivity to trastuzumab or murine proteins or any components of the product",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Adult patient, >/= 18 years of age",
            "criterions": [
                {
                    "exact_snippets": "Adult patient, >/= 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HER2-positive breast cancer",
            "criterions": [
                {
                    "exact_snippets": "HER2-positive breast cancer",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2-positive breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically confirmed invasive breast carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed invasive breast carcinoma",
                    "criterion": "invasive breast carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinical stage T1-4/N0-3/M0 at presentation (patients with T1a/bN0 tumors will not be eligible)",
            "criterions": [
                {
                    "exact_snippets": "Clinical stage T1-4/N0-3/M0 at presentation",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "T stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "T"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "T"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "N stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "N"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "M stage",
                            "expected_value": {
                                "operator": "=",
                                "value": 0,
                                "unit": "M"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with T1a/bN0 tumors will not be eligible",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "T1a/bN0"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Completion of preoperative systemic chemotherapy and HER2-directed treatment consisting of at least 6 cycles of chemotherapy with a total duration of at least 16 weeks, including at least 9 weeks of trastuzumab and at least 9 weeks of taxane-based therapy",
            "criterions": [
                {
                    "exact_snippets": "Completion of preoperative systemic chemotherapy",
                    "criterion": "preoperative systemic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2-directed treatment",
                    "criterion": "HER2-directed treatment",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 6 cycles of chemotherapy",
                    "criterion": "chemotherapy cycles",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "cycles"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "total duration of at least 16 weeks",
                    "criterion": "chemotherapy duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 16,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 9 weeks of trastuzumab",
                    "criterion": "trastuzumab duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 9 weeks of taxane-based therapy",
                    "criterion": "taxane-based therapy duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes as specified in protocol",
            "criterions": [
                {
                    "exact_snippets": "surgical removal of all clinically evident disease in the breast",
                    "criterion": "disease in the breast",
                    "requirements": [
                        {
                            "requirement_type": "surgical removal",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "surgical removal of all clinically evident disease in the ... lymph nodes",
                    "criterion": "disease in the lymph nodes",
                    "requirements": [
                        {
                            "requirement_type": "surgical removal",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pathological evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy",
            "criterions": [
                {
                    "exact_snippets": "Pathological evidence of residual invasive carcinoma in the breast",
                    "criterion": "residual invasive carcinoma in the breast",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Pathological evidence of residual invasive carcinoma in the ... axillary lymph nodes",
                    "criterion": "residual invasive carcinoma in the axillary lymph nodes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* An interval of no more than 12 weeks between the date of surgery and the date of randomization",
            "criterions": [
                {
                    "exact_snippets": "An interval of no more than 12 weeks between the date of surgery and the date of randomization",
                    "criterion": "interval between surgery and randomization",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known hormone-receptor status",
            "criterions": [
                {
                    "exact_snippets": "Known hormone-receptor status",
                    "criterion": "hormone-receptor status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate hematologic, renal and liver function",
            "criterions": [
                {
                    "exact_snippets": "Adequate hematologic",
                    "criterion": "hematologic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... renal",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... liver function",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Screening Left ventricular ejection fraction (LVEF) >/= 50% on echocardiogram (ECHO) or multiple-gated acquisition (MUGA) after receiving neoadjuvant chemotherapy and no decrease in LVEF by more than 15% absolute points from the pre-chemotherapy LVEF. Or, if pre-chemotherapy LVEF was not assessed, the screening LVEF must be >/= 55% after completion of neoadjuvant chemotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Screening Left ventricular ejection fraction (LVEF) >/= 50% on echocardiogram (ECHO) or multiple-gated acquisition (MUGA) after receiving neoadjuvant chemotherapy",
                    "criterion": "screening LVEF",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "echocardiogram (ECHO)",
                                "multiple-gated acquisition (MUGA)"
                            ]
                        },
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no decrease in LVEF by more than 15% absolute points from the pre-chemotherapy LVEF",
                    "criterion": "LVEF decrease",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 15,
                                "unit": "% absolute points"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "if pre-chemotherapy LVEF was not assessed, the screening LVEF must be >/= 55% after completion of neoadjuvant chemotherapy",
                    "criterion": "screening LVEF without pre-chemotherapy assessment",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 55,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For women who are not postmenopausal or surgically sterile: agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 7 months after the last dose of study drug",
            "criterions": [
                {
                    "exact_snippets": "women who are not postmenopausal or surgically sterile",
                    "criterion": "menopausal or surgical sterility status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "not postmenopausal or surgically sterile"
                        }
                    ]
                },
                {
                    "exact_snippets": "agreement to remain abstinent or use single or combined contraceptive methods",
                    "criterion": "contraceptive agreement",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": "remain abstinent or use contraceptive methods"
                        }
                    ]
                },
                {
                    "exact_snippets": "contraceptive methods that result in a failure rate of < 1% per year",
                    "criterion": "contraceptive method failure rate",
                    "requirements": [
                        {
                            "requirement_type": "failure rate",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "% per year"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "during the treatment period and for at least 7 months after the last dose of study drug",
                    "criterion": "contraceptive duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during treatment and 7 months after last dose"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Documentation of hepatitis B virus and hepatitis C virus serology is required",
            "criterions": [
                {
                    "exact_snippets": "Documentation of hepatitis B virus ... serology is required",
                    "criterion": "hepatitis B virus serology",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Documentation of ... hepatitis C virus serology is required",
                    "criterion": "hepatitis C virus serology",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Stage IV (metastatic) breast cancer",
            "criterions": [
                {
                    "exact_snippets": "Stage IV (metastatic) breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        },
                        {
                            "requirement_type": "metastatic",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of any prior (ipsi- or contralateral breast cancer except lobular carcinoma in situ",
            "criterions": [
                {
                    "exact_snippets": "History of any prior (ipsi- or contralateral breast cancer",
                    "criterion": "prior breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except lobular carcinoma in situ",
                    "criterion": "lobular carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of clinically evident gross residual or recurrent disease following preoperative therapy and surgery",
            "criterions": [
                {
                    "exact_snippets": "clinically evident gross residual or recurrent disease",
                    "criterion": "gross residual or recurrent disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "following preoperative therapy and surgery",
                    "criterion": "preoperative therapy and surgery",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Progressive disease during preoperative systemic therapy",
            "criterions": [
                {
                    "exact_snippets": "Progressive disease during preoperative systemic therapy",
                    "criterion": "progressive disease",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "during preoperative systemic therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treatment with any anti-cancer investigational drug within 28 days prior to commencing study treatment",
            "criterions": [
                {
                    "exact_snippets": "Treatment with any anti-cancer investigational drug within 28 days prior to commencing study treatment",
                    "criterion": "anti-cancer investigational drug treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of other malignancy within the last 5 years except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other non-breast malignancies with a similar outcome to those mentioned above",
            "criterions": [
                {
                    "exact_snippets": "History of other malignancy within the last 5 years",
                    "criterion": "history of other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except for appropriately treated carcinoma in situ of the cervix",
                    "criterion": "appropriately treated carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ... non-melanoma skin carcinoma",
                    "criterion": "non-melanoma skin carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ... Stage I uterine cancer",
                    "criterion": "Stage I uterine cancer",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ... other non-breast malignancies with a similar outcome to those mentioned above",
                    "criterion": "other non-breast malignancies with a similar outcome",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons",
            "criterions": [
                {
                    "exact_snippets": "radiotherapy would be recommended for breast cancer treatment",
                    "criterion": "radiotherapy recommendation",
                    "requirements": [
                        {
                            "requirement_type": "indication",
                            "expected_value": "breast cancer treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "radiotherapy ... is contraindicated because of medical reasons",
                    "criterion": "radiotherapy contraindication",
                    "requirements": [
                        {
                            "requirement_type": "reason",
                            "expected_value": "medical reasons"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current NCI CTCAE (Version 4.0) Grade >/= 2 peripheral neuropathy",
            "criterions": [
                {
                    "exact_snippets": "Current NCI CTCAE (Version 4.0) Grade >/= 2 peripheral neuropathy",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "NCI CTCAE Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of exposure to the following cumulative doses of anthracyclines: Doxorubicin > 240 mg/m2; Epirubicin or Liposomal Doxorubicin-Hydrochloride (Myocet®) > 480 mg/m2; For other anthracyclines, exposure equivalent to doxorubicin > 240 mg/m2",
            "criterions": [
                {
                    "exact_snippets": "History of exposure to the following cumulative doses of anthracyclines: Doxorubicin > 240 mg/m2",
                    "criterion": "doxorubicin exposure",
                    "requirements": [
                        {
                            "requirement_type": "cumulative dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 240,
                                "unit": "mg/m2"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "History of exposure to the following cumulative doses of anthracyclines: ... Epirubicin or Liposomal Doxorubicin-Hydrochloride (Myocet®) > 480 mg/m2",
                    "criterion": "epirubicin or liposomal doxorubicin-hydrochloride exposure",
                    "requirements": [
                        {
                            "requirement_type": "cumulative dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 480,
                                "unit": "mg/m2"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "History of exposure to the following cumulative doses of anthracyclines: ... For other anthracyclines, exposure equivalent to doxorubicin > 240 mg/m2",
                    "criterion": "other anthracyclines exposure equivalent to doxorubicin",
                    "requirements": [
                        {
                            "requirement_type": "cumulative dose equivalent",
                            "expected_value": {
                                "operator": ">",
                                "value": 240,
                                "unit": "mg/m2"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cardiopulmonary dysfunction as defined by protocol",
            "criterions": [
                {
                    "exact_snippets": "Cardiopulmonary dysfunction",
                    "criterion": "cardiopulmonary dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "as defined by protocol"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment with trastuzumab emtansine",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with trastuzumab emtansine",
                    "criterion": "trastuzumab emtansine treatment",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current severe, uncontrolled systemic disease",
            "criterions": [
                {
                    "exact_snippets": "Current severe, uncontrolled systemic disease",
                    "criterion": "systemic disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or lactating women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any known active liver disease, e.g. due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis",
            "criterions": [
                {
                    "exact_snippets": "Any known active liver disease",
                    "criterion": "active liver disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HBV",
                    "criterion": "HBV",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HCV",
                    "criterion": "HCV",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "autoimmune hepatic disorders",
                    "criterion": "autoimmune hepatic disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sclerosing cholangitis",
                    "criterion": "sclerosing cholangitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent serious uncontrolled infections requiring treatment or known infection with HIV",
            "criterions": [
                {
                    "exact_snippets": "Concurrent serious uncontrolled infections requiring treatment",
                    "criterion": "serious uncontrolled infections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known infection with HIV",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of intolerance, including Grade 3 to 4 infusion reaction or hypersensitivity to trastuzumab or murine proteins or any components of the product",
            "criterions": [
                {
                    "exact_snippets": "History of intolerance, including Grade 3 to 4 infusion reaction or hypersensitivity to trastuzumab",
                    "criterion": "intolerance to trastuzumab",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "Grade"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "History of intolerance, including Grade 3 to 4 infusion reaction or hypersensitivity to ... murine proteins",
                    "criterion": "intolerance to murine proteins",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "Grade"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "History of intolerance, including Grade 3 to 4 infusion reaction or hypersensitivity to ... any components of the product",
                    "criterion": "intolerance to any components of the product",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "Grade"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}