{
    "info": {
        "nct_id": "NCT00679341",
        "official_title": "A Randomized, Multicenter, Phase ii Study of the Efficacy and Safety of Trastuzumab-MCC-DM1 vs. Trastuzumab (Herceptin®) and Docetaxel (Taxotere®) in Patients With Metastatic HER2-positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metastatic Disease",
        "inclusion_criteria": "* Histologically or cytologically confirmed adenocarcinoma of the breast with locally advanced or metastatic disease, and a candidate for chemotherapy.\n* Human epidermal growth factor receptor 2 (HER2)-positive.\n* No prior chemotherapy for their metastatic breast cancer (MBC).\n* Measurable disease.\n* Age ≥ 18 years.\n* For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective, non-hormonal form of contraception or 2 effective forms of non-hormonal contraception by the patient and/or partner. Contraception use must continue for the duration of study treatment and for at least 6 months after the last dose of study treatment. Male patients whose partners are pregnant should use condoms for the duration of the study.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* History of any chemotherapy for MBC.\n* An interval of < 6 months from the completion of cytotoxic chemotherapy in the neo-adjuvant or adjuvant setting until the time of metastatic diagnosis.\n* Trastuzumab ≤ 21 days prior to randomization.\n* Hormone therapy < 7 days prior to randomization.\n* Current peripheral neuropathy of Grade ≥ 3.\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 cancers with a similar outcome as those previously mentioned.\n* Previous radiotherapy for the treatment of unresectable, locally advanced or metastatic breast cancer is not allowed if more than 25% of marrow-bearing bone has been irradiated or the last fraction of radiotherapy has been administered within approximately 3 weeks prior to randomization.\n* Brain metastases that are untreated, symptomatic, or require therapy to control symptoms or any radiation, surgery, or other therapy to control symptoms from brain metastases within 2 months prior to randomization.\n* History of exposure to the following cumulative doses of anthracyclines: Doxorubicin or liposomal doxorubicin > 500 mg/m^2; epirubicin > 900 mg/m^2; mitoxantrone > 120mg/m^2 and idarubicin > 90 mg/m^2.\n* Current unstable angina.\n* History of symptomatic congestive heart failure, or ventricular arrhythmia requiring treatment.\n* History of myocardial infarction within 6 months prior to randomization.\n* Left ventricular ejection fraction (LVEF) below 50% within approximately 28 days prior to randomization.\n* History of decreased LVEF or symptomatic congestive heart failure (CHF) with previous adjuvant trastuzumab treatment.\n* Cardiac troponin I ≥ 0.2 ng/mL within 28 days of randomization.\n* Severe dyspnea at rest because of complications of advanced malignancy or requiring current continuous oxygen therapy.\n* Current severe, uncontrolled systemic disease (eg, clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures).\n* Major surgical procedure or significant traumatic injury within approximately 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment.\n* Current pregnancy or lactation.\n* History of receiving any investigational treatment within approximately 28 days prior to randomization.\n* Current known infection with human immunodeficiency virus (HIV), active hepatitis B and/or hepatitis C virus.\n* History of intolerance (including Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab, murine proteins, or docetaxel.\n* Known hypersensitivity to any of the study drugs, including the excipients, or any drugs formulated in polysorbate 80.\n* Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically or cytologically confirmed adenocarcinoma of the breast with locally advanced or metastatic disease, and a candidate for chemotherapy.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Histologically or cytologically confirmed adenocarcinoma of the breast"
                    ],
                    "criterion": "adenocarcinoma of the breast",
                    "requirement_type": "confirmation method",
                    "expected_value": [
                        "histologically",
                        "cytologically"
                    ]
                },
                {
                    "exact_snippets": [
                        "locally advanced or metastatic disease"
                    ],
                    "criterion": "disease stage",
                    "requirement_type": "stage",
                    "expected_value": [
                        "locally advanced",
                        "metastatic"
                    ]
                },
                {
                    "exact_snippets": [
                        "candidate for chemotherapy"
                    ],
                    "criterion": "chemotherapy",
                    "requirement_type": "eligibility",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Human epidermal growth factor receptor 2 (HER2)-positive.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Human epidermal growth factor receptor 2 (HER2)-positive"
                    ],
                    "criterion": "HER2",
                    "requirement_type": "status",
                    "expected_value": "positive"
                }
            ]
        },
        {
            "line": "* No prior chemotherapy for their metastatic breast cancer (MBC).",
            "criterions": [
                {
                    "exact_snippets": [
                        "No prior chemotherapy",
                        "metastatic breast cancer (MBC)"
                    ],
                    "criterion": "prior chemotherapy for metastatic breast cancer",
                    "requirement_type": "absence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Measurable disease.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Measurable disease"
                    ],
                    "criterion": "disease",
                    "requirement_type": "measurability",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Age ≥ 18 years.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Age ≥ 18 years"
                    ],
                    "criterion": "age",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 18
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective, non-hormonal form of contraception or 2 effective forms of non-hormonal contraception by the patient and/or partner. Contraception use must continue for the duration of study treatment and for at least 6 months after the last dose of study treatment. Male patients whose partners are pregnant should use condoms for the duration of the study.",
            "criterions": [
                {
                    "exact_snippets": [
                        "women of childbearing potential"
                    ],
                    "criterion": "childbearing potential",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "men with partners of childbearing potential"
                    ],
                    "criterion": "partner's childbearing potential",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "agreement to use a highly effective, non-hormonal form of contraception or 2 effective forms of non-hormonal contraception"
                    ],
                    "criterion": "contraception",
                    "requirement_type": "type",
                    "expected_value": [
                        "highly effective, non-hormonal",
                        "2 effective forms of non-hormonal"
                    ]
                },
                {
                    "exact_snippets": [
                        "Contraception use must continue for the duration of study treatment and for at least 6 months after the last dose of study treatment"
                    ],
                    "criterion": "contraception",
                    "requirement_type": "duration",
                    "expected_value": "duration of study treatment and for at least 6 months after the last dose"
                },
                {
                    "exact_snippets": [
                        "Male patients whose partners are pregnant should use condoms for the duration of the study"
                    ],
                    "criterion": "condom use",
                    "requirement_type": "condition",
                    "expected_value": "partner is pregnant"
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "volunteer health status",
                    "requirement_type": "allowance",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* History of any chemotherapy for MBC.",
            "criterions": [
                {
                    "exact_snippets": [
                        "History of any chemotherapy for MBC"
                    ],
                    "criterion": "chemotherapy for MBC",
                    "requirement_type": "history",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* An interval of < 6 months from the completion of cytotoxic chemotherapy in the neo-adjuvant or adjuvant setting until the time of metastatic diagnosis.",
            "criterions": [
                {
                    "exact_snippets": [
                        "interval of < 6 months from the completion of cytotoxic chemotherapy",
                        "until the time of metastatic diagnosis"
                    ],
                    "criterion": "interval from completion of cytotoxic chemotherapy to metastatic diagnosis",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 6
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Trastuzumab ≤ 21 days prior to randomization.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Trastuzumab ≤ 21 days prior to randomization"
                    ],
                    "criterion": "trastuzumab administration",
                    "requirement_type": "time since last administration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 21
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Hormone therapy < 7 days prior to randomization.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Hormone therapy < 7 days prior to randomization"
                    ],
                    "criterion": "hormone therapy",
                    "requirement_type": "time since last treatment",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 7
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Current peripheral neuropathy of Grade ≥ 3.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Current peripheral neuropathy"
                    ],
                    "criterion": "peripheral neuropathy",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Grade ≥ 3"
                    ],
                    "criterion": "peripheral neuropathy",
                    "requirement_type": "severity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 3
                            }
                        ]
                    }
                }
            ]
        },
        {
            "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 cancers with a similar outcome as those previously mentioned.",
            "criterions": [
                {
                    "exact_snippets": [
                        "History of other malignancy within the last 5 years"
                    ],
                    "criterion": "history of other malignancy",
                    "requirement_type": "time frame",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 5
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "appropriately treated carcinoma in situ of the cervix"
                    ],
                    "criterion": "carcinoma in situ of the cervix",
                    "requirement_type": "treatment status",
                    "expected_value": "appropriately treated"
                },
                {
                    "exact_snippets": [
                        "non-melanoma skin carcinoma"
                    ],
                    "criterion": "non-melanoma skin carcinoma",
                    "requirement_type": "exclusion",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Stage I uterine cancer"
                    ],
                    "criterion": "Stage I uterine cancer",
                    "requirement_type": "exclusion",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "other cancers with a similar outcome as those previously mentioned"
                    ],
                    "criterion": "other cancers",
                    "requirement_type": "outcome similarity",
                    "expected_value": "similar outcome as carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer"
                }
            ]
        },
        {
            "line": "* Previous radiotherapy for the treatment of unresectable, locally advanced or metastatic breast cancer is not allowed if more than 25% of marrow-bearing bone has been irradiated or the last fraction of radiotherapy has been administered within approximately 3 weeks prior to randomization.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Previous radiotherapy for the treatment of unresectable, locally advanced or metastatic breast cancer is not allowed"
                    ],
                    "criterion": "previous radiotherapy",
                    "requirement_type": "allowance",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "more than 25% of marrow-bearing bone has been irradiated"
                    ],
                    "criterion": "marrow-bearing bone irradiation",
                    "requirement_type": "percentage",
                    "expected_value": {
                        "operator": "<=",
                        "value": 25
                    }
                },
                {
                    "exact_snippets": [
                        "the last fraction of radiotherapy has been administered within approximately 3 weeks prior to randomization"
                    ],
                    "criterion": "time since last radiotherapy",
                    "requirement_type": "duration",
                    "expected_value": {
                        "operator": ">=",
                        "value": 3
                    }
                }
            ]
        },
        {
            "line": "* Brain metastases that are untreated, symptomatic, or require therapy to control symptoms or any radiation, surgery, or other therapy to control symptoms from brain metastases within 2 months prior to randomization.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Brain metastases",
                        "untreated"
                    ],
                    "criterion": "brain metastases",
                    "requirement_type": "treatment status",
                    "expected_value": "untreated"
                },
                {
                    "exact_snippets": [
                        "Brain metastases",
                        "symptomatic"
                    ],
                    "criterion": "brain metastases",
                    "requirement_type": "symptom status",
                    "expected_value": "symptomatic"
                },
                {
                    "exact_snippets": [
                        "Brain metastases",
                        "require therapy to control symptoms"
                    ],
                    "criterion": "brain metastases",
                    "requirement_type": "therapy requirement",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "radiation, surgery, or other therapy to control symptoms from brain metastases within 2 months prior to randomization"
                    ],
                    "criterion": "brain metastases",
                    "requirement_type": "recent therapy",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 2
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* History of exposure to the following cumulative doses of anthracyclines: Doxorubicin or liposomal doxorubicin > 500 mg/m^2; epirubicin > 900 mg/m^2; mitoxantrone > 120mg/m^2 and idarubicin > 90 mg/m^2.",
            "criterions": [
                {
                    "exact_snippets": [
                        "History of exposure to the following cumulative doses of anthracyclines: Doxorubicin or liposomal doxorubicin > 500 mg/m^2"
                    ],
                    "criterion": "doxorubicin or liposomal doxorubicin",
                    "requirement_type": "cumulative dose",
                    "expected_value": {
                        "operator": ">",
                        "value": 500
                    }
                },
                {
                    "exact_snippets": [
                        "epirubicin > 900 mg/m^2"
                    ],
                    "criterion": "epirubicin",
                    "requirement_type": "cumulative dose",
                    "expected_value": {
                        "operator": ">",
                        "value": 900
                    }
                },
                {
                    "exact_snippets": [
                        "mitoxantrone > 120mg/m^2"
                    ],
                    "criterion": "mitoxantrone",
                    "requirement_type": "cumulative dose",
                    "expected_value": {
                        "operator": ">",
                        "value": 120
                    }
                },
                {
                    "exact_snippets": [
                        "idarubicin > 90 mg/m^2"
                    ],
                    "criterion": "idarubicin",
                    "requirement_type": "cumulative dose",
                    "expected_value": {
                        "operator": ">",
                        "value": 90
                    }
                }
            ]
        },
        {
            "line": "* Current unstable angina.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Current unstable angina"
                    ],
                    "criterion": "unstable angina",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* History of symptomatic congestive heart failure, or ventricular arrhythmia requiring treatment.",
            "criterions": [
                {
                    "exact_snippets": [
                        "History of symptomatic congestive heart failure"
                    ],
                    "criterion": "congestive heart failure",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "ventricular arrhythmia requiring treatment"
                    ],
                    "criterion": "ventricular arrhythmia",
                    "requirement_type": "treatment requirement",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* History of myocardial infarction within 6 months prior to randomization.",
            "criterions": [
                {
                    "exact_snippets": [
                        "History of myocardial infarction"
                    ],
                    "criterion": "myocardial infarction",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "within 6 months prior to randomization"
                    ],
                    "criterion": "myocardial infarction",
                    "requirement_type": "recency",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 6
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Left ventricular ejection fraction (LVEF) below 50% within approximately 28 days prior to randomization.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Left ventricular ejection fraction (LVEF)",
                        "below 50%"
                    ],
                    "criterion": "left ventricular ejection fraction",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "operator": "<",
                        "value": 50
                    }
                },
                {
                    "exact_snippets": [
                        "within approximately 28 days prior to randomization"
                    ],
                    "criterion": "timeframe before randomization",
                    "requirement_type": "duration",
                    "expected_value": "approximately 28 days"
                }
            ]
        },
        {
            "line": "* History of decreased LVEF or symptomatic congestive heart failure (CHF) with previous adjuvant trastuzumab treatment.",
            "criterions": [
                {
                    "exact_snippets": [
                        "History of decreased LVEF"
                    ],
                    "criterion": "LVEF",
                    "requirement_type": "history of decrease",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "symptomatic congestive heart failure (CHF)"
                    ],
                    "criterion": "congestive heart failure (CHF)",
                    "requirement_type": "symptomatic",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "previous adjuvant trastuzumab treatment"
                    ],
                    "criterion": "adjuvant trastuzumab treatment",
                    "requirement_type": "previous",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Cardiac troponin I ≥ 0.2 ng/mL within 28 days of randomization.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Cardiac troponin I"
                    ],
                    "criterion": "cardiac troponin I",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 0.2
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "within 28 days of randomization"
                    ],
                    "criterion": "time since randomization",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 28
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Severe dyspnea at rest because of complications of advanced malignancy or requiring current continuous oxygen therapy.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Severe dyspnea at rest"
                    ],
                    "criterion": "dyspnea",
                    "requirement_type": "severity",
                    "expected_value": "severe"
                },
                {
                    "exact_snippets": [
                        "complications of advanced malignancy"
                    ],
                    "criterion": "advanced malignancy",
                    "requirement_type": "complications",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "requiring current continuous oxygen therapy"
                    ],
                    "criterion": "oxygen therapy",
                    "requirement_type": "requirement",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Major surgical procedure or significant traumatic injury within approximately 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Major surgical procedure",
                        "within approximately 28 days prior to randomization"
                    ],
                    "criterion": "major surgical procedure",
                    "requirement_type": "time since occurrence",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 28
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "significant traumatic injury",
                        "within approximately 28 days prior to randomization"
                    ],
                    "criterion": "significant traumatic injury",
                    "requirement_type": "time since occurrence",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 28
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "anticipation of the need for major surgery",
                        "during the course of study treatment"
                    ],
                    "criterion": "major surgery",
                    "requirement_type": "anticipated need",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* Current pregnancy or lactation.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Current pregnancy"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "lactation"
                    ],
                    "criterion": "lactation",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* History of receiving any investigational treatment within approximately 28 days prior to randomization.",
            "criterions": [
                {
                    "exact_snippets": [
                        "History of receiving any investigational treatment"
                    ],
                    "criterion": "investigational treatment",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "within approximately 28 days prior to randomization"
                    ],
                    "criterion": "time since last investigational treatment",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 28
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.",
            "criterions": [
                {
                    "exact_snippets": [
                        "unable or unwilling to comply with the requirements of the protocol"
                    ],
                    "criterion": "compliance with protocol requirements",
                    "requirement_type": "ability/willingness",
                    "expected_value": true
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Current severe, uncontrolled systemic disease (eg, clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures).",
            "criterions": [
                {
                    "exact_snippets": [
                        "Current severe, uncontrolled systemic disease"
                    ],
                    "criterion": "systemic disease",
                    "requirement_type": "severity",
                    "expected_value": "severe"
                },
                {
                    "exact_snippets": [
                        "clinically significant cardiovascular",
                        "disease"
                    ],
                    "criterion": "cardiovascular disease",
                    "requirement_type": "clinical significance",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "clinically significant pulmonary",
                        "disease"
                    ],
                    "criterion": "pulmonary disease",
                    "requirement_type": "clinical significance",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "clinically significant metabolic",
                        "disease"
                    ],
                    "criterion": "metabolic disease",
                    "requirement_type": "clinical significance",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "wound healing disorders"
                    ],
                    "criterion": "wound healing disorders",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "ulcers"
                    ],
                    "criterion": "ulcers",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "bone fractures"
                    ],
                    "criterion": "bone fractures",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Current known infection with human immunodeficiency virus (HIV), active hepatitis B and/or hepatitis C virus.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Current known infection with human immunodeficiency virus (HIV)"
                    ],
                    "criterion": "human immunodeficiency virus (HIV) infection",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "active hepatitis B"
                    ],
                    "criterion": "hepatitis B infection",
                    "requirement_type": "activity",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "active hepatitis C virus"
                    ],
                    "criterion": "hepatitis C virus infection",
                    "requirement_type": "activity",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* History of intolerance (including Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab, murine proteins, or docetaxel.",
            "criterions": [
                {
                    "exact_snippets": [
                        "History of intolerance",
                        "Grade 3-4 infusion reaction"
                    ],
                    "criterion": "intolerance",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "hypersensitivity to trastuzumab"
                    ],
                    "criterion": "hypersensitivity",
                    "requirement_type": "presence",
                    "expected_value": "trastuzumab"
                },
                {
                    "exact_snippets": [
                        "hypersensitivity to murine proteins"
                    ],
                    "criterion": "hypersensitivity",
                    "requirement_type": "presence",
                    "expected_value": "murine proteins"
                },
                {
                    "exact_snippets": [
                        "hypersensitivity to docetaxel"
                    ],
                    "criterion": "hypersensitivity",
                    "requirement_type": "presence",
                    "expected_value": "docetaxel"
                }
            ]
        },
        {
            "line": "* Known hypersensitivity to any of the study drugs, including the excipients, or any drugs formulated in polysorbate 80.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Known hypersensitivity to any of the study drugs"
                    ],
                    "criterion": "hypersensitivity",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "hypersensitivity to any of the study drugs, including the excipients"
                    ],
                    "criterion": "hypersensitivity",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "hypersensitivity to any drugs formulated in polysorbate 80"
                    ],
                    "criterion": "hypersensitivity",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}