{
    "info": {
        "nct_id": "NCT02581462",
        "official_title": "FLOT vs. FLOT/Herceptin/Pertuzumab for Perioperative Therapy of Adenocarcinoma of the Stomach and Gastroesophageal Junction Expressing HER-2. A Phase II/III Trial of the AIO.",
        "inclusion_criteria": "1. Histologically confirmed adenocarcinoma of the GEJ (type I-III) or the stomach (uT2, uT3, uT4, any N category, M0), or any T N+ M0 patient, with the following specifications:\n\n   * Medical and technical operability\n   * Centralized detection of either an adenocarcinoma with HER-2 3+ (IHC) or HER-2 2+ (IHC) with amplification proven by FISH, SISH or CISH\n2. No preceding cytotoxic or targeted therapy\n3. No prior partial or complete tumor resection\n4. Exclusion of the infiltration of any adjacent organs or structures by CT or MRI\n5. Exclusion of distant metastasis by CT or MRI of thorax and abdomen, and bone scan (if osseous lesions are suspected due to clinical signs)\n6. Female and male patients ≥ 18 years. Patients in reproductive age must be willing to use adequate contraception during the study and for 7 months after the end of pertuzumab and Herceptin treatment (Appropriate contraception is defined as surgical sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap)). Female patients with childbearing potential need to have a negative pregnancy test within 7 days before study start.\n7. ECOG ≤ 2\n8. Laparoscopic exclusion of peritoneal carcinomatosis, if suspected clinically\n9. Adequate haematological, hepatic and renal function parameters:\n\n   * Leukocytes ≥ 3.000/mm³, platelets ≥ 100.000/mm3\n   * Serum creatinine ≤ 1.5 x upper limit of normal, or GFR > 40 ml/min\n   * Bilirubin ≤ 1.5 x upper limit of normal, AST and ALT ≤ 3.5 x upper limit of normal, alkaline phosphatase ≤ 6 x upper limit of normal\n10. LVEF value > 55 %, as assessed by echocardiography\n11. Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 99 Years",
        "exclusion_criteria": "1. Patients with involved retroperitoneal (e.g. para-aortal, paracaval or interaortocaval lymph nodes) or mesenterial lymph nodes (distant metastasis!)\n2. Known hypersensitivity against Herceptin, pertuzumab, 5-FU, leucovorin, oxaliplatin, or docetaxel\n3. Other known contraindications against Herceptin, pertuzumab, 5-FU, leucovorin, oxaliplatin, or docetaxel\n4. Documented history of congestive heart failure of any NYHA, myocardial infarction within the past 6 months before the first dose of study treatment\n5. Clinically significant valvular defect , history of poorly controlled arterial hypertension (systolic blood pressure > 180 mmHG or diastolic blood pressure > 100 mmHg) or uncontrollable high-risk cardiac arrhythmia (i.e tachycardia with a heart rate > 100/min at rest), significant ventricular arrhythmia (ventricular tachycardia) or higher grade atrioventricular-block (second degree AV-block Type 2 (Mobitz2) or third degree AV-block)\n6. Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix\n7. Known brain metastases\n8. Other severe internal disease or acute infection\n9. Peripheral polyneuropathy ≥ NCI Grade II\n10. Chronic inflammatory bowel disease\n11. Clinically significant active GI bleeding\n12. On-treatment participation in another clinical study in the period 30 days prior to inclusion and during the study\n13. Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.\n14. Patients in a closed institution according to an authority or court decision (AMG § 40, Abs. 1 No. 4)\n15. Any other concurrent antineoplastic treatment including irradiation",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Histologically confirmed adenocarcinoma of the GEJ (type I-III) or the stomach (uT2, uT3, uT4, any N category, M0), or any T N+ M0 patient, with the following specifications:",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed adenocarcinoma of the GEJ (type I-III) or the stomach",
                    "criterion": "adenocarcinoma location",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "GEJ (type I-III)",
                                "stomach"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "uT2, uT3, uT4",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "uT2",
                                "uT3",
                                "uT4"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "any N category",
                    "criterion": "lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "category",
                            "expected_value": "any"
                        }
                    ]
                },
                {
                    "exact_snippets": "M0",
                    "criterion": "metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any T N+ M0 patient",
                    "criterion": "tumor and lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "any T"
                        },
                        {
                            "requirement_type": "lymph node involvement",
                            "expected_value": "N+"
                        },
                        {
                            "requirement_type": "metastasis",
                            "expected_value": "M0"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Medical and technical operability",
            "criterions": [
                {
                    "exact_snippets": "Medical and technical operability",
                    "criterion": "operability",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "medical",
                                "technical"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Centralized detection of either an adenocarcinoma with HER-2 3+ (IHC) or HER-2 2+ (IHC) with amplification proven by FISH, SISH or CISH",
            "criterions": [
                {
                    "exact_snippets": "adenocarcinoma",
                    "criterion": "adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HER-2 3+ (IHC)",
                    "criterion": "HER-2 status",
                    "requirements": [
                        {
                            "requirement_type": "IHC score",
                            "expected_value": "3+"
                        }
                    ]
                },
                {
                    "exact_snippets": "HER-2 2+ (IHC) with amplification proven by FISH, SISH or CISH",
                    "criterion": "HER-2 status",
                    "requirements": [
                        {
                            "requirement_type": "IHC score",
                            "expected_value": "2+"
                        },
                        {
                            "requirement_type": "amplification",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "amplification detection method",
                            "expected_value": [
                                "FISH",
                                "SISH",
                                "CISH"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. No preceding cytotoxic or targeted therapy",
            "criterions": [
                {
                    "exact_snippets": "No preceding cytotoxic ... therapy",
                    "criterion": "cytotoxic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No preceding ... targeted therapy",
                    "criterion": "targeted therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. No prior partial or complete tumor resection",
            "criterions": [
                {
                    "exact_snippets": "No prior partial or complete tumor resection",
                    "criterion": "tumor resection",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Exclusion of the infiltration of any adjacent organs or structures by CT or MRI",
            "criterions": [
                {
                    "exact_snippets": "infiltration of any adjacent organs or structures",
                    "criterion": "infiltration of adjacent organs or structures",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "by CT or MRI",
                    "criterion": "imaging method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "CT",
                                "MRI"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Exclusion of distant metastasis by CT or MRI of thorax and abdomen, and bone scan (if osseous lesions are suspected due to clinical signs)",
            "criterions": [
                {
                    "exact_snippets": "Exclusion of distant metastasis by CT or MRI of thorax and abdomen",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "bone scan (if osseous lesions are suspected due to clinical signs)",
                    "criterion": "osseous lesions",
                    "requirements": [
                        {
                            "requirement_type": "suspicion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Female and male patients ≥ 18 years. Patients in reproductive age must be willing to use adequate contraception during the study and for 7 months after the end of pertuzumab and Herceptin treatment (Appropriate contraception is defined as surgical sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap)). Female patients with childbearing potential need to have a negative pregnancy test within 7 days before study start.",
            "criterions": [
                {
                    "exact_snippets": "Female and male patients ≥ 18 years.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients in reproductive age must be willing to use adequate contraception during the study and for 7 months after the end of pertuzumab and Herceptin treatment",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Female patients with childbearing potential need to have a negative pregnancy test within 7 days before study start.",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. ECOG ≤ 2",
            "criterions": [
                {
                    "exact_snippets": "ECOG ≤ 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Laparoscopic exclusion of peritoneal carcinomatosis, if suspected clinically",
            "criterions": [
                {
                    "exact_snippets": "Laparoscopic exclusion of peritoneal carcinomatosis",
                    "criterion": "peritoneal carcinomatosis",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Adequate haematological, hepatic and renal function parameters:",
            "criterions": [
                {
                    "exact_snippets": "Adequate haematological ... function parameters",
                    "criterion": "haematological function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... hepatic ... function parameters",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... renal function parameters",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Leukocytes ≥ 3.000/mm³, platelets ≥ 100.000/mm3",
            "criterions": [
                {
                    "exact_snippets": "Leukocytes ≥ 3.000/mm³",
                    "criterion": "leukocytes",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3000,
                                "unit": "mm³"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelets ≥ 100.000/mm3",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine ≤ 1.5 x upper limit of normal, or GFR > 40 ml/min",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine ≤ 1.5 x upper limit of normal",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "GFR > 40 ml/min",
                    "criterion": "GFR",
                    "requirements": [
                        {
                            "requirement_type": "rate",
                            "expected_value": {
                                "operator": ">",
                                "value": 40,
                                "unit": "ml/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin ≤ 1.5 x upper limit of normal, AST and ALT ≤ 3.5 x upper limit of normal, alkaline phosphatase ≤ 6 x upper limit of normal",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin ≤ 1.5 x upper limit of normal",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST and ALT ≤ 3.5 x upper limit of normal",
                    "criterion": "AST and ALT levels",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3.5,
                                "unit": "x upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alkaline phosphatase ≤ 6 x upper limit of normal",
                    "criterion": "alkaline phosphatase level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "x upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. LVEF value > 55 %, as assessed by echocardiography",
            "criterions": [
                {
                    "exact_snippets": "LVEF value > 55 %",
                    "criterion": "LVEF",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 55,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "as assessed by echocardiography",
                    "criterion": "echocardiography",
                    "requirements": [
                        {
                            "requirement_type": "assessment_method",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures",
            "criterions": [
                {
                    "exact_snippets": "Patient able and willing to provide written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient able and willing ... to comply with the study protocol",
                    "criterion": "compliance with study protocol",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient able and willing ... to comply ... with the planned surgical procedures",
                    "criterion": "compliance with planned surgical procedures",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "willingness",
                            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 99 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 99 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 99,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Patients with involved retroperitoneal (e.g. para-aortal, paracaval or interaortocaval lymph nodes) or mesenterial lymph nodes (distant metastasis!)",
            "criterions": [
                {
                    "exact_snippets": "involved retroperitoneal (e.g. para-aortal, paracaval or interaortocaval lymph nodes)",
                    "criterion": "retroperitoneal lymph nodes",
                    "requirements": [
                        {
                            "requirement_type": "involvement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "involved ... mesenterial lymph nodes",
                    "criterion": "mesenterial lymph nodes",
                    "requirements": [
                        {
                            "requirement_type": "involvement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Known hypersensitivity against Herceptin, pertuzumab, 5-FU, leucovorin, oxaliplatin, or docetaxel",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity against Herceptin",
                    "criterion": "hypersensitivity to Herceptin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known hypersensitivity against ... pertuzumab",
                    "criterion": "hypersensitivity to pertuzumab",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known hypersensitivity against ... 5-FU",
                    "criterion": "hypersensitivity to 5-FU",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known hypersensitivity against ... leucovorin",
                    "criterion": "hypersensitivity to leucovorin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known hypersensitivity against ... oxaliplatin",
                    "criterion": "hypersensitivity to oxaliplatin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known hypersensitivity against ... docetaxel",
                    "criterion": "hypersensitivity to docetaxel",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Documented history of congestive heart failure of any NYHA, myocardial infarction within the past 6 months before the first dose of study treatment",
            "criterions": [
                {
                    "exact_snippets": "Documented history of congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction within the past 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Clinically significant valvular defect , history of poorly controlled arterial hypertension (systolic blood pressure > 180 mmHG or diastolic blood pressure > 100 mmHg) or uncontrollable high-risk cardiac arrhythmia (i.e tachycardia with a heart rate > 100/min at rest), significant ventricular arrhythmia (ventricular tachycardia) or higher grade atrioventricular-block (second degree AV-block Type 2 (Mobitz2) or third degree AV-block)",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant valvular defect",
                    "criterion": "valvular defect",
                    "requirements": [
                        {
                            "requirement_type": "significance",
                            "expected_value": "clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "history of poorly controlled arterial hypertension",
                    "criterion": "arterial hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    ]
                },
                {
                    "exact_snippets": "systolic blood pressure > 180 mmHG",
                    "criterion": "systolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 180,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "diastolic blood pressure > 100 mmHg",
                    "criterion": "diastolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 100,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrollable high-risk cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrollable"
                        },
                        {
                            "requirement_type": "risk",
                            "expected_value": "high-risk"
                        }
                    ]
                },
                {
                    "exact_snippets": "tachycardia with a heart rate > 100/min at rest",
                    "criterion": "tachycardia",
                    "requirements": [
                        {
                            "requirement_type": "heart rate",
                            "expected_value": {
                                "operator": ">",
                                "value": 100,
                                "unit": "min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "significant ventricular arrhythmia",
                    "criterion": "ventricular arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "significance",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "ventricular tachycardia",
                    "criterion": "ventricular tachycardia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "higher grade atrioventricular-block",
                    "criterion": "atrioventricular-block",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": "higher grade"
                        }
                    ]
                },
                {
                    "exact_snippets": "second degree AV-block Type 2 (Mobitz2)",
                    "criterion": "second degree AV-block Type 2 (Mobitz2)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "third degree AV-block",
                    "criterion": "third degree AV-block",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix",
            "criterions": [
                {
                    "exact_snippets": "Past or current history of other malignancies not curatively treated",
                    "criterion": "other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "not curatively treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "without evidence of disease for more than 5 years",
                    "criterion": "evidence of disease",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except for curatively treated basal cell carcinoma of the skin",
                    "criterion": "basal cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "curatively treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ... in situ carcinoma of the cervix",
                    "criterion": "in situ carcinoma of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "curatively treated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Known brain metastases",
            "criterions": [
                {
                    "exact_snippets": "Known brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Other severe internal disease or acute infection",
            "criterions": [
                {
                    "exact_snippets": "Other severe internal disease",
                    "criterion": "internal disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "acute infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "acute"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Peripheral polyneuropathy ≥ NCI Grade II",
            "criterions": [
                {
                    "exact_snippets": "Peripheral polyneuropathy ≥ NCI Grade II",
                    "criterion": "peripheral polyneuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "NCI Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Chronic inflammatory bowel disease",
            "criterions": [
                {
                    "exact_snippets": "Chronic inflammatory bowel disease",
                    "criterion": "chronic inflammatory bowel disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Clinically significant active GI bleeding",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant active GI bleeding",
                    "criterion": "GI bleeding",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. On-treatment participation in another clinical study in the period 30 days prior to inclusion and during the study",
            "criterions": [
                {
                    "exact_snippets": "On-treatment participation in another clinical study",
                    "criterion": "participation in another clinical study",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "on-treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "in the period 30 days prior to inclusion",
                    "criterion": "participation in another clinical study",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "30 days prior to inclusion"
                        }
                    ]
                },
                {
                    "exact_snippets": "during the study",
                    "criterion": "participation in another clinical study",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "during the study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.",
            "criterions": [
                {
                    "exact_snippets": "Subject pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast feeding",
                    "criterion": "breastfeeding status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "planning to become pregnant within 6 months after the end of treatment",
                    "criterion": "pregnancy planning",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 6 months after the end of treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Patients in a closed institution according to an authority or court decision (AMG § 40, Abs. 1 No. 4)",
            "criterions": [
                {
                    "exact_snippets": "Patients in a closed institution according to an authority or court decision",
                    "criterion": "institutionalization",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Any other concurrent antineoplastic treatment including irradiation",
            "criterions": [
                {
                    "exact_snippets": "Any other concurrent antineoplastic treatment",
                    "criterion": "concurrent antineoplastic treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "including irradiation",
                    "criterion": "irradiation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "3. Other known contraindications against Herceptin, pertuzumab, 5-FU, leucovorin, oxaliplatin, or docetaxel",
            "criterions": [
                {
                    "exact_snippets": "contraindications against Herceptin",
                    "criterion": "contraindications against Herceptin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "contraindications against pertuzumab",
                    "criterion": "contraindications against pertuzumab",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "contraindications against 5-FU",
                    "criterion": "contraindications against 5-FU",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "contraindications against leucovorin",
                    "criterion": "contraindications against leucovorin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "contraindications against oxaliplatin",
                    "criterion": "contraindications against oxaliplatin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "contraindications against docetaxel",
                    "criterion": "contraindications against docetaxel",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}