{
    "info": {
        "nct_id": "NCT00876460",
        "official_title": "A Phase I Study of Continuous, Concomitant Oral Treatment With BIBF 1120 and Docetaxel - a Phase I, Open-label, Dose-escalation Study in Japanese Patients With Stage IIIB/IV or Recurrent Non-small-cell Lung Cancer After Failure of Chemotherapy",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 20 Years\nMust have maximum age of 74 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion criteria:\n\n1. Histologically/cytologically confirmed, locally advanced/metastatic NSCLC of stage IIIB/IV or recurrent NSCLC (all histologies. Existence or nonexistence of measurable lesion according to RECIST is no object.)\n2. Patients with one prior chemotherapy regimen including platinum-containing drug.\n\n   In case of recurrent disease, one additional prior regimen is allowed for adjuvant and/or neoadjuvant therapy. However monotherapy of EGFR-TKI (i.e. erlotinib/Tarceva® and gefitinib/Iressa®) is not counted as 'one regimen'.\n3. Male or female patients age >=20 years and =<74 years at the enrolment.\n4. Life expectancy of at least three (3) months after the start of administration of the investigational drug.\n5. Eastern Cooperative Oncology Group (ECOG) [R01-0787] performance Score 0 or 1.\n6. Patients retaining a significant physiological compensatory function and patients with sufficient baseline organ function as follows:\n\n   * Haemoglobin count more than 9.0g/dL\n   * Absolute neutrophil count more than 1500/mm3\n   * Platelet count more than 100 000/mm3\n   * Serum creatinine less than or equal to1.5x upper limit of normal range at the investigator site\n   * Aspartate aminotransferase (AST) and / or alanine aminotransferase (ALT) less than or equal to 1.5x upper limit of normal range at the investigator site (It is the same if patients have liver metastases)\n   * PaO2 or SpO2 more than 60torr or 92%\n7. Written informed consent that is consistent with ICH-GCP guidelines.\n\nExclusion criteria:\n\n1. Patients who have received chemotherapy (including other investigational drug), hormonal therapy and immune therapy =<4 weeks prior to registration or who have not recovered from side effects of such therapy.\n2. Patients who have received radiotherapy =<4 weeks (limited field (e.g brain or bone metastasis) radiation =<2 weeks) prior to registration.\n3. Patients who have active brain metastases. (Patients who have no symptoms and is not needed to receive therapy in the registration may participate in this trial)\n4. Patients with active double cancer. (Patients who have skin cancer that is not malignant melanoma and carcinoma in situ of uterine cervix may participate in this trial)\n5. Patients with distinct / suspected pulmonary fibrosis or interstitial lung disease by the chest radiographic findings, or patients with a previous history of.\n6. History of clinically significant haemoptysis within the past 3 months (more than one tea spoon of fresh blood per day)\n7. Therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy (except for chronic low-dose therapy with acetylsalicylic acid =<325 mg per day)\n8. History of major thrombotic or clinically relevant major bleeding event in the past 6 months prior to registration.\n9. Known inherited predisposition to bleeding or thrombosis.\n10. Significant cardiovascular diseases. (i.e. hypertension not controlled by medical therapy, unstable angina, history of myocardial infarction within the past 6 months, congestive heart failure > NYHA II, serious cardiac arrhythmia, pericardial effusion)\n11. Significant weight loss (> 10 %) within the past 6 weeks prior to registration in the this trial\n12. Current peripheral neuropathy >= CTCAE grade 2 except due to trauma.\n13. Accumulation of coelomic fluid (e.g. pleural effusion, ascites fluid, cardiac effusion) requiring treatment\n14. Major injuries and/or surgery within the past 10 days prior to registration with incomplete wound healing.\n15. Serious infections requiring systemic antibiotic (e.g antiviral, antimicrobial, antifungal) therapy.\n16. Decompensated diabetes mellitus or other contraindication to high dose corticosteroid therapy.\n17. Gastrointestinal disorders or abnormalities (e.g Crohn's disease, Colitis ulcerosa and extensive gastrectomy) that would interfere with absorption of the study drug.\n18. Patients with difficulty in swallowing study medication\n19. Patients with positive HBs antigen, HCV antibody, or HIV antibody test\n20. Serious illness or concomitant non-oncological disease such as neurologic-, psychiatric-, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with trial participation or investigational drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the trial.\n21. Patients who are sexually active and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females, condoms for participating males) during the trial and for at least 12 months after end of active therapy\n22. Female patients who are pregnant, breast feeding and may become pregnant.\n23. Patients who have or is suspected of having active alcohol or drug abuse.\n24. Patient with clinically meaningful drug hypersensitivities.\n25. Patients with auto immune disease.\n26. Patients unable to comply with the protocol.\n27. Other patients judged ineligible for enrolment in the study by the investigator."
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 20 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 20 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 20 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 74 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 74 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 74,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 74 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 74,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "identified_line": {
                "line": "1. Histologically/cytologically confirmed, locally advanced/metastatic NSCLC of stage IIIB/IV or recurrent NSCLC (all histologies. Existence or nonexistence of measurable lesion according to RECIST is no object.)",
                "criterions": [
                    {
                        "exact_snippets": "Histologically/cytologically confirmed",
                        "criterion": "NSCLC confirmation",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "locally advanced/metastatic NSCLC of stage IIIB/IV",
                        "criterion": "NSCLC stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "IIIB",
                                "IV"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "recurrent NSCLC",
                        "criterion": "NSCLC recurrence",
                        "requirement": {
                            "requirement_type": "recurrence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Histologically/cytologically confirmed",
                                "criterion": "NSCLC confirmation",
                                "requirement": {
                                    "requirement_type": "confirmation method",
                                    "expected_value": [
                                        "histologically",
                                        "cytologically"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "locally advanced/metastatic NSCLC of stage IIIB/IV",
                                "criterion": "NSCLC stage",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": [
                                        "IIIB",
                                        "IV"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Histologically/cytologically confirmed",
                                "criterion": "NSCLC confirmation",
                                "requirement": {
                                    "requirement_type": "confirmation method",
                                    "expected_value": [
                                        "histologically",
                                        "cytologically"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "recurrent NSCLC",
                                "criterion": "NSCLC recurrence",
                                "requirement": {
                                    "requirement_type": "recurrence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Patients with one prior chemotherapy regimen including platinum-containing drug.",
                "criterions": [
                    {
                        "exact_snippets": "Patients with one prior chemotherapy regimen",
                        "criterion": "prior chemotherapy regimen",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "regimen"
                            }
                        }
                    },
                    {
                        "exact_snippets": "platinum-containing drug",
                        "criterion": "chemotherapy drug type",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "platinum-containing"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients with one prior chemotherapy regimen",
                        "criterion": "prior chemotherapy regimen",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "regimen"
                            }
                        }
                    },
                    {
                        "exact_snippets": "platinum-containing drug",
                        "criterion": "chemotherapy drug type",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "platinum-containing"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "In case of recurrent disease, one additional prior regimen is allowed for adjuvant and/or neoadjuvant therapy. However monotherapy of EGFR-TKI (i.e. erlotinib/Tarceva® and gefitinib/Iressa®) is not counted as 'one regimen'.",
                "criterions": [
                    {
                        "exact_snippets": "recurrent disease",
                        "criterion": "recurrent disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "one additional prior regimen is allowed for adjuvant and/or neoadjuvant therapy",
                        "criterion": "prior regimen for adjuvant/neoadjuvant therapy",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "additional"
                            }
                        }
                    },
                    {
                        "exact_snippets": "monotherapy of EGFR-TKI (i.e. erlotinib/Tarceva® and gefitinib/Iressa®) is not counted as 'one regimen'",
                        "criterion": "monotherapy of EGFR-TKI",
                        "requirement": {
                            "requirement_type": "counted as one regimen",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "recurrent disease",
                    "criterion": "recurrent disease",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "one additional prior regimen is allowed for adjuvant and/or neoadjuvant therapy",
                            "criterion": "prior regimen for adjuvant/neoadjuvant therapy",
                            "requirement": {
                                "requirement_type": "quantity",
                                "expected_value": {
                                    "operator": "=",
                                    "value": 1,
                                    "unit": "additional"
                                }
                            }
                        },
                        {
                            "exact_snippets": "monotherapy of EGFR-TKI (i.e. erlotinib/Tarceva® and gefitinib/Iressa®) is not counted as 'one regimen'",
                            "criterion": "monotherapy of EGFR-TKI",
                            "requirement": {
                                "requirement_type": "counted as one regimen",
                                "expected_value": false
                            }
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "3. Male or female patients age >=20 years and =<74 years at the enrolment.",
                "criterions": [
                    {
                        "exact_snippets": "Male or female patients",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "age >=20 years and =<74 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 20,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 74,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Male or female patients",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "age >=20 years and =<74 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 20,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 74,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Life expectancy of at least three (3) months after the start of administration of the investigational drug.",
                "criterions": [
                    {
                        "exact_snippets": "Life expectancy of at least three (3) months",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Life expectancy of at least three (3) months",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Eastern Cooperative Oncology Group (ECOG) [R01-0787] performance Score 0 or 1.",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) ... performance Score 0 or 1.",
                        "criterion": "ECOG performance score",
                        "requirement": {
                            "requirement_type": "score",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) ... performance Score 0 or 1.",
                        "criterion": "ECOG performance score",
                        "requirement": {
                            "requirement_type": "score",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Patients retaining a significant physiological compensatory function and patients with sufficient baseline organ function as follows:",
                "criterions": [
                    {
                        "exact_snippets": "Patients retaining a significant physiological compensatory function",
                        "criterion": "physiological compensatory function",
                        "requirement": {
                            "requirement_type": "retention",
                            "expected_value": "significant"
                        }
                    },
                    {
                        "exact_snippets": "patients with sufficient baseline organ function",
                        "criterion": "baseline organ function",
                        "requirement": {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients retaining a significant physiological compensatory function",
                        "criterion": "physiological compensatory function",
                        "requirement": {
                            "requirement_type": "retention",
                            "expected_value": "significant"
                        }
                    },
                    {
                        "exact_snippets": "patients with sufficient baseline organ function",
                        "criterion": "baseline organ function",
                        "requirement": {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Haemoglobin count more than 9.0g/dL",
                "criterions": [
                    {
                        "exact_snippets": "Haemoglobin count more than 9.0g/dL",
                        "criterion": "haemoglobin count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 9.0,
                                "unit": "g/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Haemoglobin count more than 9.0g/dL",
                        "criterion": "haemoglobin count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 9.0,
                                "unit": "g/dL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Absolute neutrophil count more than 1500/mm3",
                "criterions": [
                    {
                        "exact_snippets": "Absolute neutrophil count more than 1500/mm3",
                        "criterion": "absolute neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1500,
                                "unit": "mm3"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Absolute neutrophil count more than 1500/mm3",
                        "criterion": "absolute neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1500,
                                "unit": "mm3"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Platelet count more than 100 000/mm3",
                "criterions": [
                    {
                        "exact_snippets": "Platelet count more than 100 000/mm3",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Platelet count more than 100 000/mm3",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Aspartate aminotransferase (AST) and / or alanine aminotransferase (ALT) less than or equal to 1.5x upper limit of normal range at the investigator site (It is the same if patients have liver metastases)",
                "criterions": [
                    {
                        "exact_snippets": "Aspartate aminotransferase (AST) ... less than or equal to 1.5x upper limit of normal range",
                        "criterion": "Aspartate aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x upper limit of normal range"
                            }
                        }
                    },
                    {
                        "exact_snippets": "alanine aminotransferase (ALT) less than or equal to 1.5x upper limit of normal range",
                        "criterion": "alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x upper limit of normal range"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Aspartate aminotransferase (AST) ... less than or equal to 1.5x upper limit of normal range",
                                "criterion": "Aspartate aminotransferase (AST)",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "x upper limit of normal range"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "alanine aminotransferase (ALT) less than or equal to 1.5x upper limit of normal range",
                                "criterion": "alanine aminotransferase (ALT)",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "x upper limit of normal range"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* PaO2 or SpO2 more than 60torr or 92%",
                "criterions": [
                    {
                        "exact_snippets": "PaO2 ... more than 60torr",
                        "criterion": "PaO2",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "torr"
                            }
                        }
                    },
                    {
                        "exact_snippets": "SpO2 ... more than ... 92%",
                        "criterion": "SpO2",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 92,
                                "unit": "%"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "PaO2 ... more than 60torr",
                        "criterion": "PaO2",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "torr"
                            }
                        }
                    },
                    {
                        "exact_snippets": "SpO2 ... more than ... 92%",
                        "criterion": "SpO2",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 92,
                                "unit": "%"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Written informed consent that is consistent with ICH-GCP guidelines.",
                "criterions": [
                    {
                        "exact_snippets": "Written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "consistency",
                            "expected_value": "ICH-GCP guidelines"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "consistency",
                            "expected_value": "ICH-GCP guidelines"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. Patients who have received chemotherapy (including other investigational drug), hormonal therapy and immune therapy =<4 weeks prior to registration or who have not recovered from side effects of such therapy.",
                "criterions": [
                    {
                        "exact_snippets": "Patients who have received chemotherapy ... =<4 weeks prior to registration",
                        "criterion": "chemotherapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Patients who have received ... hormonal therapy ... =<4 weeks prior to registration",
                        "criterion": "hormonal therapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Patients who have received ... immune therapy =<4 weeks prior to registration",
                        "criterion": "immune therapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Patients who have received ... other investigational drug ... =<4 weeks prior to registration",
                        "criterion": "other investigational drug",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Patients ... who have not recovered from side effects of such therapy",
                        "criterion": "recovery from side effects",
                        "requirement": {
                            "requirement_type": "recovery status",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Patients who have received chemotherapy ... =<4 weeks prior to registration",
                                        "criterion": "chemotherapy",
                                        "requirement": {
                                            "requirement_type": "time since last treatment",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 4,
                                                "unit": "weeks"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "Patients ... who have not recovered from side effects of such therapy",
                                        "criterion": "recovery from side effects",
                                        "requirement": {
                                            "requirement_type": "recovery status",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Patients who have received ... hormonal therapy ... =<4 weeks prior to registration",
                                        "criterion": "hormonal therapy",
                                        "requirement": {
                                            "requirement_type": "time since last treatment",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 4,
                                                "unit": "weeks"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "Patients ... who have not recovered from side effects of such therapy",
                                        "criterion": "recovery from side effects",
                                        "requirement": {
                                            "requirement_type": "recovery status",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Patients who have received ... immune therapy =<4 weeks prior to registration",
                                        "criterion": "immune therapy",
                                        "requirement": {
                                            "requirement_type": "time since last treatment",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 4,
                                                "unit": "weeks"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "Patients ... who have not recovered from side effects of such therapy",
                                        "criterion": "recovery from side effects",
                                        "requirement": {
                                            "requirement_type": "recovery status",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Patients who have received ... other investigational drug ... =<4 weeks prior to registration",
                                        "criterion": "other investigational drug",
                                        "requirement": {
                                            "requirement_type": "time since last treatment",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 4,
                                                "unit": "weeks"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "Patients ... who have not recovered from side effects of such therapy",
                                        "criterion": "recovery from side effects",
                                        "requirement": {
                                            "requirement_type": "recovery status",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Patients who have received radiotherapy =<4 weeks (limited field (e.g brain or bone metastasis) radiation =<2 weeks) prior to registration.",
                "criterions": [
                    {
                        "exact_snippets": "Patients who have received radiotherapy =<4 weeks",
                        "criterion": "radiotherapy",
                        "requirement": {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "limited field (e.g brain or bone metastasis) radiation =<2 weeks",
                        "criterion": "limited field radiation",
                        "requirement": {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Patients who have received radiotherapy =<4 weeks",
                                "criterion": "radiotherapy",
                                "requirement": {
                                    "requirement_type": "time since treatment",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "limited field (e.g brain or bone metastasis) radiation =<2 weeks",
                                "criterion": "limited field radiation",
                                "requirement": {
                                    "requirement_type": "time since treatment",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. History of major thrombotic or clinically relevant major bleeding event in the past 6 months prior to registration.",
                "criterions": [
                    {
                        "exact_snippets": "History of major thrombotic ... event in the past 6 months",
                        "criterion": "major thrombotic event",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of major thrombotic ... event in the past 6 months",
                        "criterion": "major thrombotic event",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "History of ... clinically relevant major bleeding event in the past 6 months",
                        "criterion": "clinically relevant major bleeding event",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of ... clinically relevant major bleeding event in the past 6 months",
                        "criterion": "clinically relevant major bleeding event",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of major thrombotic ... event in the past 6 months",
                                "criterion": "major thrombotic event",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "History of major thrombotic ... event in the past 6 months",
                                "criterion": "major thrombotic event",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "<=",
                                                "value": 6,
                                                "unit": "months"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of ... clinically relevant major bleeding event in the past 6 months",
                                "criterion": "clinically relevant major bleeding event",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "History of ... clinically relevant major bleeding event in the past 6 months",
                                "criterion": "clinically relevant major bleeding event",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "<=",
                                                "value": 6,
                                                "unit": "months"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. Known inherited predisposition to bleeding or thrombosis.",
                "criterions": [
                    {
                        "exact_snippets": "Known inherited predisposition to bleeding",
                        "criterion": "inherited predisposition to bleeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Known inherited predisposition to ... thrombosis",
                        "criterion": "inherited predisposition to thrombosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Known inherited predisposition to bleeding",
                        "criterion": "inherited predisposition to bleeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Known inherited predisposition to ... thrombosis",
                        "criterion": "inherited predisposition to thrombosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "10. Significant cardiovascular diseases. (i.e. hypertension not controlled by medical therapy, unstable angina, history of myocardial infarction within the past 6 months, congestive heart failure > NYHA II, serious cardiac arrhythmia, pericardial effusion)",
                "criterions": [
                    {
                        "exact_snippets": "hypertension not controlled by medical therapy",
                        "criterion": "hypertension",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "not controlled by medical therapy"
                        }
                    },
                    {
                        "exact_snippets": "unstable angina",
                        "criterion": "unstable angina",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "history of myocardial infarction within the past 6 months",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "congestive heart failure > NYHA II",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "NYHA"
                            }
                        }
                    },
                    {
                        "exact_snippets": "serious cardiac arrhythmia",
                        "criterion": "cardiac arrhythmia",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    },
                    {
                        "exact_snippets": "pericardial effusion",
                        "criterion": "pericardial effusion",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "hypertension not controlled by medical therapy",
                                "criterion": "hypertension",
                                "requirement": {
                                    "requirement_type": "control",
                                    "expected_value": "not controlled by medical therapy"
                                }
                            },
                            {
                                "exact_snippets": "unstable angina",
                                "criterion": "unstable angina",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "history of myocardial infarction within the past 6 months",
                                "criterion": "myocardial infarction",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "congestive heart failure > NYHA II",
                                "criterion": "congestive heart failure",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 2,
                                        "unit": "NYHA"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "serious cardiac arrhythmia",
                                "criterion": "cardiac arrhythmia",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "serious"
                                }
                            },
                            {
                                "exact_snippets": "pericardial effusion",
                                "criterion": "pericardial effusion",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "11. Significant weight loss (> 10 %) within the past 6 weeks prior to registration in the this trial",
                "criterions": [
                    {
                        "exact_snippets": "Significant weight loss (> 10 %) within the past 6 weeks",
                        "criterion": "weight loss",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Significant weight loss (> 10 %) within the past 6 weeks",
                        "criterion": "weight loss",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within the past 6 weeks"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Significant weight loss (> 10 %) within the past 6 weeks",
                        "criterion": "weight loss",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Significant weight loss (> 10 %) within the past 6 weeks",
                        "criterion": "weight loss",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within the past 6 weeks"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "12. Current peripheral neuropathy >= CTCAE grade 2 except due to trauma.",
                "criterions": [
                    {
                        "exact_snippets": "Current peripheral neuropathy >= CTCAE grade 2",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "CTCAE grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "except due to trauma",
                        "criterion": "cause of peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": "trauma"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "exact_snippets": "Current peripheral neuropathy >= CTCAE grade 2",
                            "criterion": "peripheral neuropathy",
                            "requirement": {
                                "requirement_type": "severity",
                                "expected_value": {
                                    "operator": ">=",
                                    "value": 2,
                                    "unit": "CTCAE grade"
                                }
                            }
                        },
                        {
                            "exact_snippets": "except due to trauma",
                            "criterion": "cause of peripheral neuropathy",
                            "requirement": {
                                "requirement_type": "exclusion",
                                "expected_value": "trauma"
                            }
                        }
                    ]
                },
                "then_criteria": {
                    "not_criteria": {
                        "exact_snippets": "Current peripheral neuropathy >= CTCAE grade 2",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "CTCAE grade"
                            }
                        }
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "13. Accumulation of coelomic fluid (e.g. pleural effusion, ascites fluid, cardiac effusion) requiring treatment",
                "criterions": [
                    {
                        "exact_snippets": "Accumulation of coelomic fluid (e.g. pleural effusion, ascites fluid, cardiac effusion) requiring treatment",
                        "criterion": "coelomic fluid accumulation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Accumulation of coelomic fluid (e.g. pleural effusion, ascites fluid, cardiac effusion) requiring treatment",
                        "criterion": "coelomic fluid accumulation",
                        "requirement": {
                            "requirement_type": "treatment requirement",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Accumulation of coelomic fluid (e.g. pleural effusion, ascites fluid, cardiac effusion) requiring treatment",
                        "criterion": "coelomic fluid accumulation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Accumulation of coelomic fluid (e.g. pleural effusion, ascites fluid, cardiac effusion) requiring treatment",
                        "criterion": "coelomic fluid accumulation",
                        "requirement": {
                            "requirement_type": "treatment requirement",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "14. Major injuries and/or surgery within the past 10 days prior to registration with incomplete wound healing.",
                "criterions": [
                    {
                        "exact_snippets": "Major injuries ... within the past 10 days prior to registration",
                        "criterion": "major injuries",
                        "requirement": {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "surgery within the past 10 days prior to registration",
                        "criterion": "surgery",
                        "requirement": {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "incomplete wound healing",
                        "criterion": "wound healing",
                        "requirement": {
                            "requirement_type": "completeness",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Major injuries ... within the past 10 days prior to registration",
                                "criterion": "major injuries",
                                "requirement": {
                                    "requirement_type": "time since occurrence",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 10,
                                        "unit": "days"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "surgery within the past 10 days prior to registration",
                                "criterion": "surgery",
                                "requirement": {
                                    "requirement_type": "time since occurrence",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 10,
                                        "unit": "days"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "incomplete wound healing",
                        "criterion": "wound healing",
                        "requirement": {
                            "requirement_type": "completeness",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "15. Serious infections requiring systemic antibiotic (e.g antiviral, antimicrobial, antifungal) therapy.",
                "criterions": [
                    {
                        "exact_snippets": "Serious infections requiring systemic antibiotic (e.g antiviral, antimicrobial, antifungal) therapy.",
                        "criterion": "serious infections",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "systemic antibiotic therapy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Serious infections requiring systemic antibiotic (e.g antiviral, antimicrobial, antifungal) therapy.",
                        "criterion": "serious infections",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "systemic antibiotic therapy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "16. Decompensated diabetes mellitus or other contraindication to high dose corticosteroid therapy.",
                "criterions": [
                    {
                        "exact_snippets": "Decompensated diabetes mellitus",
                        "criterion": "decompensated diabetes mellitus",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "other contraindication to high dose corticosteroid therapy",
                        "criterion": "contraindication to high dose corticosteroid therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Decompensated diabetes mellitus",
                        "criterion": "decompensated diabetes mellitus",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "other contraindication to high dose corticosteroid therapy",
                        "criterion": "contraindication to high dose corticosteroid therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "17. Gastrointestinal disorders or abnormalities (e.g Crohn's disease, Colitis ulcerosa and extensive gastrectomy) that would interfere with absorption of the study drug.",
                "criterions": [
                    {
                        "exact_snippets": "Gastrointestinal disorders or abnormalities (e.g Crohn's disease, Colitis ulcerosa and extensive gastrectomy)",
                        "criterion": "gastrointestinal disorders or abnormalities",
                        "requirement": {
                            "requirement_type": "interference with absorption",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Gastrointestinal disorders or abnormalities (e.g Crohn's disease, Colitis ulcerosa and extensive gastrectomy)",
                        "criterion": "gastrointestinal disorders or abnormalities",
                        "requirement": {
                            "requirement_type": "interference with absorption",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "18. Patients with difficulty in swallowing study medication",
                "criterions": [
                    {
                        "exact_snippets": "difficulty in swallowing study medication",
                        "criterion": "swallowing ability",
                        "requirement": {
                            "requirement_type": "difficulty",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "difficulty in swallowing study medication",
                    "criterion": "swallowing ability",
                    "requirement": {
                        "requirement_type": "difficulty",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "19. Patients with positive HBs antigen, HCV antibody, or HIV antibody test",
                "criterions": [
                    {
                        "exact_snippets": "positive HBs antigen",
                        "criterion": "HBs antigen",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "HCV antibody",
                        "criterion": "HCV antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "HIV antibody",
                        "criterion": "HIV antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "positive HBs antigen",
                        "criterion": "HBs antigen",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "HCV antibody",
                        "criterion": "HCV antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "HIV antibody",
                        "criterion": "HIV antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "20. Serious illness or concomitant non-oncological disease such as neurologic-, psychiatric-, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with trial participation or investigational drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the trial.",
                "criterions": [
                    {
                        "exact_snippets": "Serious illness or concomitant non-oncological disease such as neurologic-, psychiatric-, infectious disease",
                        "criterion": "serious illness or concomitant non-oncological disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "active ulcers (gastro-intestinal tract, skin)",
                        "criterion": "active ulcers",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "laboratory abnormality that may increase the risk associated with trial participation or investigational drug administration",
                        "criterion": "laboratory abnormality",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Serious illness or concomitant non-oncological disease such as neurologic-, psychiatric-, infectious disease",
                                        "criterion": "serious illness or concomitant non-oncological disease",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "active ulcers (gastro-intestinal tract, skin)",
                                        "criterion": "active ulcers",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "laboratory abnormality that may increase the risk associated with trial participation or investigational drug administration",
                                "criterion": "laboratory abnormality",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "21. Patients who are sexually active and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females, condoms for participating males) during the trial and for at least 12 months after end of active therapy",
                "criterions": [
                    {
                        "exact_snippets": "Patients who are sexually active",
                        "criterion": "sexual activity",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "unwilling to use a medically acceptable method of contraception",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "during the trial and for at least 12 months after end of active therapy",
                        "criterion": "contraception duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "during the trial and for at least 12 months after end of active therapy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Patients who are sexually active",
                                    "criterion": "sexual activity",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "exact_snippets": "unwilling to use a medically acceptable method of contraception",
                                    "criterion": "contraception use",
                                    "requirement": {
                                        "requirement_type": "willingness",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "exact_snippets": "during the trial and for at least 12 months after end of active therapy",
                                    "criterion": "contraception duration",
                                    "requirement": {
                                        "requirement_type": "duration",
                                        "expected_value": "during the trial and for at least 12 months after end of active therapy"
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "22. Female patients who are pregnant, breast feeding and may become pregnant.",
                "criterions": [
                    {
                        "exact_snippets": "Female patients who are pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "breast feeding",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "may become pregnant",
                        "criterion": "potential to become pregnant",
                        "requirement": {
                            "requirement_type": "potential",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Female patients who are pregnant",
                                "criterion": "pregnancy",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "breast feeding",
                                "criterion": "breastfeeding",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "may become pregnant",
                        "criterion": "potential to become pregnant",
                        "requirement": {
                            "requirement_type": "potential",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "23. Patients who have or is suspected of having active alcohol or drug abuse.",
                "criterions": [
                    {
                        "exact_snippets": "Patients who have or is suspected of having active alcohol ... abuse.",
                        "criterion": "alcohol abuse",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Patients who have or is suspected of having active ... drug abuse.",
                        "criterion": "drug abuse",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Patients who have or is suspected of having active alcohol ... abuse.",
                        "criterion": "alcohol abuse",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Patients who have or is suspected of having active ... drug abuse.",
                        "criterion": "drug abuse",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "24. Patient with clinically meaningful drug hypersensitivities.",
                "criterions": [
                    {
                        "exact_snippets": "clinically meaningful drug hypersensitivities",
                        "criterion": "drug hypersensitivities",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "clinically meaningful"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "clinically meaningful drug hypersensitivities",
                        "criterion": "drug hypersensitivities",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "clinically meaningful"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "25. Patients with auto immune disease.",
                "criterions": [
                    {
                        "exact_snippets": "Patients with auto immune disease",
                        "criterion": "auto immune disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients with auto immune disease",
                        "criterion": "auto immune disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "26. Patients unable to comply with the protocol.",
                "criterions": [
                    {
                        "exact_snippets": "Patients unable to comply with the protocol",
                        "criterion": "compliance with protocol",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Patients unable to comply with the protocol",
                    "criterion": "compliance with protocol",
                    "requirement": {
                        "requirement_type": "ability",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "27. Other patients judged ineligible for enrolment in the study by the investigator.",
                "criterions": [
                    {
                        "exact_snippets": "Other patients judged ineligible for enrolment in the study by the investigator.",
                        "criterion": "investigator judgment",
                        "requirement": {
                            "requirement_type": "eligibility",
                            "expected_value": "ineligible"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Other patients judged ineligible for enrolment in the study by the investigator.",
                    "criterion": "investigator judgment",
                    "requirement": {
                        "requirement_type": "eligibility",
                        "expected_value": "ineligible"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "Inclusion criteria:",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        },
        {
            "identified_line": {
                "line": "* Serum creatinine less than or equal to1.5x upper limit of normal range at the investigator site",
                "criterions": [
                    {
                        "exact_snippets": "Serum creatinine less than or equal to 1.5x upper limit of normal range",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x upper limit of normal range"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Serum creatinine less than or equal to 1.5x upper limit of normal range",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x upper limit of normal range"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Exclusion criteria:",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "identified_line": {
                "line": "3. Patients who have active brain metastases. (Patients who have no symptoms and is not needed to receive therapy in the registration may participate in this trial)",
                "criterions": [
                    {
                        "exact_snippets": "Patients who have active brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Patients who have no symptoms",
                        "criterion": "symptoms of brain metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "is not needed to receive therapy in the registration",
                        "criterion": "therapy for brain metastases",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "4. Patients with active double cancer. (Patients who have skin cancer that is not malignant melanoma and carcinoma in situ of uterine cervix may participate in this trial)",
                "criterions": [
                    {
                        "exact_snippets": "Patients with active double cancer.",
                        "criterion": "active double cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "skin cancer that is not malignant melanoma",
                        "criterion": "skin cancer",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "not malignant melanoma"
                        }
                    },
                    {
                        "exact_snippets": "carcinoma in situ of uterine cervix",
                        "criterion": "carcinoma in situ of uterine cervix",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "5. Patients with distinct / suspected pulmonary fibrosis or interstitial lung disease by the chest radiographic findings, or patients with a previous history of.",
                "criterions": [
                    {
                        "exact_snippets": "distinct / suspected pulmonary fibrosis",
                        "criterion": "pulmonary fibrosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "interstitial lung disease by the chest radiographic findings",
                        "criterion": "interstitial lung disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "previous history of",
                        "criterion": "pulmonary fibrosis or interstitial lung disease",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "6. History of clinically significant haemoptysis within the past 3 months (more than one tea spoon of fresh blood per day)",
                "criterions": [
                    {
                        "exact_snippets": "History of clinically significant haemoptysis within the past 3 months",
                        "criterion": "haemoptysis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of clinically significant haemoptysis within the past 3 months",
                        "criterion": "haemoptysis",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within the past 3 months"
                        }
                    },
                    {
                        "exact_snippets": "History of clinically significant haemoptysis within the past 3 months",
                        "criterion": "haemoptysis",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    },
                    {
                        "exact_snippets": "more than one tea spoon of fresh blood per day",
                        "criterion": "haemoptysis",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "tea spoon per day"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "7. Therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy (except for chronic low-dose therapy with acetylsalicylic acid =<325 mg per day)",
                "criterions": [
                    {
                        "exact_snippets": "Therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device)",
                        "criterion": "therapeutic anticoagulation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "antiplatelet therapy (except for chronic low-dose therapy with acetylsalicylic acid =<325 mg per day)",
                        "criterion": "antiplatelet therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ]
}