{
    "info": {
        "nct_id": "NCT03207672",
        "official_title": "An Open-label Phase 1 Study of E7389 Liposomal Formulation in Subjects With Solid Tumor",
        "inclusion_criteria": "* Participants with advanced, nonresectable, or recurrent solid tumor for which no alternative standard therapy or no effective therapy exists\n* Expansion-part 1 only: breast cancer with confirmed diagnosis, human epidermal growth factor (HER2) negative (immunohistochemistry [IHC] 0/1+, or fluorescence in situ hybridization [FISH] negative), prior chemotherapy of anthracycline and taxane (unless contraindicated), and up to 3 prior chemotherapy regimens to advanced or metastatic disease Expansion-part 2 only: nonresectable ACC with confirmed diagnosis and one or more prior chemotherapy regimens (unless contraindicated) Expansion-part 3, 4 and 5 only: nonresectable GC, EGC and SCLC with confirmed diagnosis and 2 or more prior chemotherapy regimens (unless contraindicated) (1 or more prior chemotherapy regimens for EGC participant who received combination therapy of platinum and taxane).\n\nEx-part 6 only: breast cancer with confirmed diagnosis, HER2 negative (IHC 0/1+, or FISH negative) and without prior chemotherapy regimens to advanced or metastatic disease. Participants with triple-negative breast cancer (TNBC) who are PD-L1 negative as assessed by the site or who are medically determined by the investigator(s) to be ineligible for treatment with atezolizumab and other immune-checkpoint inhibitors will be included.\n\n* Life expectancy of greater than or equal to (>=) 12 weeks\n* Eastern Cooperative Oncology Group-Performance Status (ECOG-PS) of 0 to 1\n* Japanese participants aged >=20 years at the time of informed consent\n* All adverse events (AEs) due to previous anti-cancer therapy have either returned to Grade 0 or 1 except for alopecia and Grade 2 peripheral neuropathy\n* Adequate washout period before study drug administration:\n\n  * Chemotherapy, hormonal therapy and radiotherapy: 3 weeks or more\n  * Any therapy with antibody: 4 weeks or more\n  * Any investigational drug or device: 4 weeks or more\n  * Blood/platelet transfusion or granulocyte-colony stimulating factor (G-CSF): 2 weeks or more\n* Adequate renal function defined as serum creatinine less than (<) 2.0 milligrams per deciliter (mg/dL) or creatinine clearance >=40 milliliters per minute (mL/min) per the Cockcroft and Gault formula\n* Adequate bone marrow function:\n\n  * Absolute neutrophil count (ANC) >=2,000/millimeters cubed (mm^3) (>=2.0 × 10^3/microliter [µl])\n  * Platelets >=100,000/mm^3 (>=100 × 10^9/Liter [L])\n  * Hemoglobin >=9.0 grams (g)/dL (Expansion-part only: >=8.5 g/dL)\n* Adequate liver function:\n\n  * Adequate blood coagulation function as evidenced by an International Normalized Ratio (INR) less than or equal to (<=) 1.5\n  * Total bilirubin <=1.5 × upper limit of normal (ULN) except for unconjugated hyperbilirubinemia or Gilbert's syndrome\n  * Alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) <=3 × ULN (<=5.0 times ULN in the participants with liver metastases)\n* Expansion-part only: At least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\n* Willing and able to give informed consent and comply with all aspects of the protocol\nHealthy volunteers allowed\nMust have minimum age of 20 Years",
        "exclusion_criteria": "* Any of cardiac conditions as follows:\n\n  * Heart failure New York Heart Association (NYHA) Class II or above\n  * Unstable ischaemic heart disease (myocardial infarction within 6 months prior to starting study drug, or angina requiring use of nitrates more than once weekly)\n  * Prolongation of Fridericia's corrected QT (QTcF) interval to greater than (>) 480 milliseconds (msec)\n* History of hypersensitivity reaction by liposomal formulation agent\n* Major surgery within 21 days prior to starting study drug\n* Previous treatment with eribulin\n* Previous radiation therapy encompassing an extensive region including the bone marrow (example, >30% of bone marrow)\n* Known intolerance to the study drug or any of the excipients\n* Known to be human immunodeficiency virus (HIV) positive\n* Active viral hepatitis (B or C) as demonstrated by positive serology or requiring treatment\n* Diagnosed with meningeal carcinomatosis\n* Participants with brain or subdural metastases or invasion are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (example, radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment.\n* Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.\n* Expansion-part only: history of active malignancy (except for primary tumor, or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, carcinoma in-situ of the bladder or cervix, or early stage gastric/colorectal cancer) within the past 24 months prior to the first dose of study drug\n* Evidence of clinically significant disease/status (example, cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments\n* Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [β-hCG] or hCG test). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.\n* Males with impregnate potential or females of childbearing potential who or whose partner do not agree with medically effective method of contraception throughout the entire study period and for 28 days (90 days for male) after study drug discontinuation\n* Ex-part 6 only: Active or acute oral infection requiring dental treatment\n* Ex-part 6 only: Participants who received taxanes as neoadjuvant or adjuvant chemotherapy and have radiographically progressive disease by investigator(s) decision within 12 months after the last dose of taxane\n* Ex-part 6 only: Child-Pugh score B or C",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Expansion-part 1 only: breast cancer with confirmed diagnosis, human epidermal growth factor (HER2) negative (immunohistochemistry [IHC] 0/1+, or fluorescence in situ hybridization [FISH] negative), prior chemotherapy of anthracycline and taxane (unless contraindicated), and up to 3 prior chemotherapy regimens to advanced or metastatic disease Expansion-part 2 only: nonresectable ACC with confirmed diagnosis and one or more prior chemotherapy regimens (unless contraindicated) Expansion-part 3, 4 and 5 only: nonresectable GC, EGC and SCLC with confirmed diagnosis and 2 or more prior chemotherapy regimens (unless contraindicated) (1 or more prior chemotherapy regimens for EGC participant who received combination therapy of platinum and taxane).",
                "criterions": [
                    {
                        "exact_snippets": "breast cancer with confirmed diagnosis",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": "confirmed"
                        }
                    },
                    {
                        "exact_snippets": "human epidermal growth factor (HER2) negative (immunohistochemistry [IHC] 0/1+, or fluorescence in situ hybridization [FISH] negative)",
                        "criterion": "HER2 status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "prior chemotherapy of anthracycline and taxane (unless contraindicated)",
                        "criterion": "prior chemotherapy",
                        "requirement": {
                            "requirement_type": "regimen",
                            "expected_value": [
                                "anthracycline",
                                "taxane"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "up to 3 prior chemotherapy regimens to advanced or metastatic disease",
                        "criterion": "prior chemotherapy regimens",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "regimens"
                            }
                        }
                    },
                    {
                        "exact_snippets": "nonresectable ACC with confirmed diagnosis",
                        "criterion": "nonresectable ACC",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": "confirmed"
                        }
                    },
                    {
                        "exact_snippets": "one or more prior chemotherapy regimens (unless contraindicated)",
                        "criterion": "prior chemotherapy regimens",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "regimens"
                            }
                        }
                    },
                    {
                        "exact_snippets": "nonresectable GC, EGC and SCLC with confirmed diagnosis",
                        "criterion": "nonresectable GC, EGC and SCLC",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": "confirmed"
                        }
                    },
                    {
                        "exact_snippets": "2 or more prior chemotherapy regimens (unless contraindicated)",
                        "criterion": "prior chemotherapy regimens",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "regimens"
                            }
                        }
                    },
                    {
                        "exact_snippets": "1 or more prior chemotherapy regimens for EGC participant who received combination therapy of platinum and taxane",
                        "criterion": "prior chemotherapy regimens for EGC",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "regimens"
                            }
                        }
                    },
                    {
                        "exact_snippets": "1 or more prior chemotherapy regimens for EGC participant who received combination therapy of platinum and taxane",
                        "criterion": "prior chemotherapy regimens for EGC",
                        "requirement": {
                            "requirement_type": "combination therapy",
                            "expected_value": [
                                "platinum",
                                "taxane"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "breast cancer with confirmed diagnosis",
                                "criterion": "breast cancer",
                                "requirement": {
                                    "requirement_type": "diagnosis",
                                    "expected_value": "confirmed"
                                }
                            },
                            {
                                "exact_snippets": "human epidermal growth factor (HER2) negative (immunohistochemistry [IHC] 0/1+, or fluorescence in situ hybridization [FISH] negative)",
                                "criterion": "HER2 status",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": "negative"
                                }
                            },
                            {
                                "exact_snippets": "prior chemotherapy of anthracycline and taxane (unless contraindicated)",
                                "criterion": "prior chemotherapy",
                                "requirement": {
                                    "requirement_type": "regimen",
                                    "expected_value": [
                                        "anthracycline",
                                        "taxane"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "up to 3 prior chemotherapy regimens to advanced or metastatic disease",
                                "criterion": "prior chemotherapy regimens",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "regimens"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "nonresectable ACC with confirmed diagnosis",
                                "criterion": "nonresectable ACC",
                                "requirement": {
                                    "requirement_type": "diagnosis",
                                    "expected_value": "confirmed"
                                }
                            },
                            {
                                "exact_snippets": "one or more prior chemotherapy regimens (unless contraindicated)",
                                "criterion": "prior chemotherapy regimens",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "regimens"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "nonresectable GC, EGC and SCLC with confirmed diagnosis",
                                "criterion": "nonresectable GC, EGC and SCLC",
                                "requirement": {
                                    "requirement_type": "diagnosis",
                                    "expected_value": "confirmed"
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "2 or more prior chemotherapy regimens (unless contraindicated)",
                                        "criterion": "prior chemotherapy regimens",
                                        "requirement": {
                                            "requirement_type": "quantity",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 2,
                                                "unit": "regimens"
                                            }
                                        }
                                    },
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "1 or more prior chemotherapy regimens for EGC participant who received combination therapy of platinum and taxane",
                                                "criterion": "prior chemotherapy regimens for EGC",
                                                "requirement": {
                                                    "requirement_type": "quantity",
                                                    "expected_value": {
                                                        "operator": ">=",
                                                        "value": 1,
                                                        "unit": "regimens"
                                                    }
                                                }
                                            },
                                            {
                                                "exact_snippets": "1 or more prior chemotherapy regimens for EGC participant who received combination therapy of platinum and taxane",
                                                "criterion": "prior chemotherapy regimens for EGC",
                                                "requirement": {
                                                    "requirement_type": "combination therapy",
                                                    "expected_value": [
                                                        "platinum",
                                                        "taxane"
                                                    ]
                                                }
                                            }
                                        ]
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adequate washout period before study drug administration:",
                "criterions": [
                    {
                        "exact_snippets": "Adequate washout period",
                        "criterion": "washout period",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate washout period",
                        "criterion": "washout period",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Chemotherapy, hormonal therapy and radiotherapy: 3 weeks or more",
                "criterions": [
                    {
                        "exact_snippets": "Chemotherapy, hormonal therapy and radiotherapy: 3 weeks or more",
                        "criterion": "chemotherapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Chemotherapy, hormonal therapy and radiotherapy: 3 weeks or more",
                        "criterion": "hormonal therapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Chemotherapy, hormonal therapy and radiotherapy: 3 weeks or more",
                        "criterion": "radiotherapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Chemotherapy, hormonal therapy and radiotherapy: 3 weeks or more",
                                "criterion": "chemotherapy",
                                "requirement": {
                                    "requirement_type": "time since last treatment",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "weeks"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Chemotherapy, hormonal therapy and radiotherapy: 3 weeks or more",
                                "criterion": "hormonal therapy",
                                "requirement": {
                                    "requirement_type": "time since last treatment",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Chemotherapy, hormonal therapy and radiotherapy: 3 weeks or more",
                        "criterion": "radiotherapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any therapy with antibody: 4 weeks or more",
                "criterions": [
                    {
                        "exact_snippets": "Any therapy with antibody: 4 weeks or more",
                        "criterion": "therapy with antibody",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Any therapy with antibody: 4 weeks or more",
                        "criterion": "therapy with antibody",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any investigational drug or device: 4 weeks or more",
                "criterions": [
                    {
                        "exact_snippets": "Any investigational drug or device: 4 weeks or more",
                        "criterion": "investigational drug or device",
                        "requirement": {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Any investigational drug or device: 4 weeks or more",
                        "criterion": "investigational drug or device",
                        "requirement": {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Blood/platelet transfusion or granulocyte-colony stimulating factor (G-CSF): 2 weeks or more",
                "criterions": [
                    {
                        "exact_snippets": "Blood/platelet transfusion ... 2 weeks or more",
                        "criterion": "blood/platelet transfusion",
                        "requirement": {
                            "requirement_type": "time since last event",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "granulocyte-colony stimulating factor (G-CSF) ... 2 weeks or more",
                        "criterion": "granulocyte-colony stimulating factor (G-CSF)",
                        "requirement": {
                            "requirement_type": "time since last event",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Blood/platelet transfusion ... 2 weeks or more",
                        "criterion": "blood/platelet transfusion",
                        "requirement": {
                            "requirement_type": "time since last event",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "granulocyte-colony stimulating factor (G-CSF) ... 2 weeks or more",
                        "criterion": "granulocyte-colony stimulating factor (G-CSF)",
                        "requirement": {
                            "requirement_type": "time since last event",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adequate renal function defined as serum creatinine less than (<) 2.0 milligrams per deciliter (mg/dL) or creatinine clearance >=40 milliliters per minute (mL/min) per the Cockcroft and Gault formula",
                "criterions": [
                    {
                        "exact_snippets": "Adequate renal function defined as serum creatinine less than (<) 2.0 milligrams per deciliter (mg/dL)",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Adequate renal function defined as ... creatinine clearance >=40 milliliters per minute (mL/min) per the Cockcroft and Gault formula",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 40,
                                "unit": "mL/min"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Adequate renal function defined as serum creatinine less than (<) 2.0 milligrams per deciliter (mg/dL)",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Adequate renal function defined as ... creatinine clearance >=40 milliliters per minute (mL/min) per the Cockcroft and Gault formula",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 40,
                                "unit": "mL/min"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adequate bone marrow function:",
                "criterions": [
                    {
                        "exact_snippets": "Adequate bone marrow function",
                        "criterion": "bone marrow function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate bone marrow function",
                        "criterion": "bone marrow function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Absolute neutrophil count (ANC) >=2,000/millimeters cubed (mm^3) (>=2.0 × 10^3/microliter [µl])",
                "criterions": [
                    {
                        "exact_snippets": "Absolute neutrophil count (ANC) >=2,000/millimeters cubed (mm^3) (>=2.0 × 10^3/microliter [µl])",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2000,
                                "unit": "millimeters cubed (mm^3)"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Absolute neutrophil count (ANC) >=2,000/millimeters cubed (mm^3) (>=2.0 × 10^3/microliter [µl])",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2000,
                                "unit": "millimeters cubed (mm^3)"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Platelets >=100,000/mm^3 (>=100 × 10^9/Liter [L])",
                "criterions": [
                    {
                        "exact_snippets": "Platelets >=100,000/mm^3 (>=100 × 10^9/Liter [L])",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Platelets >=100,000/mm^3 (>=100 × 10^9/Liter [L])",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "10^9/L"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Platelets >=100,000/mm^3 (>=100 × 10^9/Liter [L])",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Platelets >=100,000/mm^3 (>=100 × 10^9/Liter [L])",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "10^9/L"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Hemoglobin >=9.0 grams (g)/dL (Expansion-part only: >=8.5 g/dL)",
                "criterions": [
                    {
                        "exact_snippets": "Hemoglobin >=9.0 grams (g)/dL",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9.0,
                                "unit": "g/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Expansion-part only: >=8.5 g/dL",
                        "criterion": "hemoglobin level (expansion-part only)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8.5,
                                "unit": "g/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Expansion-part only: >=8.5 g/dL",
                    "criterion": "hemoglobin level (expansion-part only)",
                    "requirement": {
                        "requirement_type": "level",
                        "expected_value": {
                            "operator": ">=",
                            "value": 8.5,
                            "unit": "g/dL"
                        }
                    }
                },
                "then_criteria": {
                    "exact_snippets": "Expansion-part only: >=8.5 g/dL",
                    "criterion": "hemoglobin level (expansion-part only)",
                    "requirement": {
                        "requirement_type": "level",
                        "expected_value": {
                            "operator": ">=",
                            "value": 8.5,
                            "unit": "g/dL"
                        }
                    }
                },
                "else_criteria": {
                    "exact_snippets": "Hemoglobin >=9.0 grams (g)/dL",
                    "criterion": "hemoglobin level",
                    "requirement": {
                        "requirement_type": "level",
                        "expected_value": {
                            "operator": ">=",
                            "value": 9.0,
                            "unit": "g/dL"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Adequate liver function:",
                "criterions": [
                    {
                        "exact_snippets": "Adequate liver function",
                        "criterion": "liver function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate liver function",
                        "criterion": "liver function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adequate blood coagulation function as evidenced by an International Normalized Ratio (INR) less than or equal to (<=) 1.5",
                "criterions": [
                    {
                        "exact_snippets": "Adequate blood coagulation function ... International Normalized Ratio (INR) less than or equal to (<=) 1.5",
                        "criterion": "blood coagulation function",
                        "requirement": {
                            "requirement_type": "INR",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate blood coagulation function ... International Normalized Ratio (INR) less than or equal to (<=) 1.5",
                        "criterion": "blood coagulation function",
                        "requirement": {
                            "requirement_type": "INR",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Expansion-part only: At least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1",
                "criterions": [
                    {
                        "exact_snippets": "At least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Expansion-part only",
                    "criterion": "trial part",
                    "requirement": {
                        "requirement_type": "phase",
                        "expected_value": "expansion"
                    }
                },
                "then_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "At least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1",
                            "criterion": "measurable lesion",
                            "requirement": {
                                "requirement_type": "quantity",
                                "expected_value": {
                                    "operator": ">=",
                                    "value": 1,
                                    "unit": "lesion"
                                }
                            }
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Willing and able to give informed consent and comply with all aspects of the protocol",
                "criterions": [
                    {
                        "exact_snippets": "Willing and able to give informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willing and able to give informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "comply with all aspects of the protocol",
                        "criterion": "protocol compliance",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "comply with all aspects of the protocol",
                        "criterion": "protocol compliance",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Willing and able to give informed consent",
                                "criterion": "informed consent",
                                "requirement": {
                                    "requirement_type": "willingness",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Willing and able to give informed consent",
                                "criterion": "informed consent",
                                "requirement": {
                                    "requirement_type": "ability",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "comply with all aspects of the protocol",
                                "criterion": "protocol compliance",
                                "requirement": {
                                    "requirement_type": "willingness",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "comply with all aspects of the protocol",
                                "criterion": "protocol compliance",
                                "requirement": {
                                    "requirement_type": "ability",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "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"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Any of cardiac conditions as follows:",
                "criterions": [
                    {
                        "exact_snippets": "cardiac conditions",
                        "criterion": "cardiac conditions",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "cardiac conditions",
                        "criterion": "cardiac conditions",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Heart failure New York Heart Association (NYHA) Class II or above",
                "criterions": [
                    {
                        "exact_snippets": "Heart failure New York Heart Association (NYHA) Class II or above",
                        "criterion": "heart failure NYHA class",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "class"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Heart failure New York Heart Association (NYHA) Class II or above",
                        "criterion": "heart failure NYHA class",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "class"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Unstable ischaemic heart disease (myocardial infarction within 6 months prior to starting study drug, or angina requiring use of nitrates more than once weekly)",
                "criterions": [
                    {
                        "exact_snippets": "Unstable ischaemic heart disease",
                        "criterion": "ischaemic heart disease",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    },
                    {
                        "exact_snippets": "myocardial infarction within 6 months prior to starting study drug",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "angina requiring use of nitrates more than once weekly",
                        "criterion": "angina",
                        "requirement": {
                            "requirement_type": "nitrate use frequency",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "times per week"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Unstable ischaemic heart disease",
                                "criterion": "ischaemic heart disease",
                                "requirement": {
                                    "requirement_type": "stability",
                                    "expected_value": "unstable"
                                }
                            },
                            {
                                "exact_snippets": "myocardial infarction within 6 months prior to starting study drug",
                                "criterion": "myocardial infarction",
                                "requirement": {
                                    "requirement_type": "time since event",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "angina requiring use of nitrates more than once weekly",
                        "criterion": "angina",
                        "requirement": {
                            "requirement_type": "nitrate use frequency",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "times per week"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Prolongation of Fridericia's corrected QT (QTcF) interval to greater than (>) 480 milliseconds (msec)",
                "criterions": [
                    {
                        "exact_snippets": "Prolongation of Fridericia's corrected QT (QTcF) interval ... greater than (>) 480 milliseconds (msec)",
                        "criterion": "Fridericia's corrected QT (QTcF) interval",
                        "requirement": {
                            "requirement_type": "prolongation",
                            "expected_value": {
                                "operator": ">",
                                "value": 480,
                                "unit": "milliseconds"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Prolongation of Fridericia's corrected QT (QTcF) interval ... greater than (>) 480 milliseconds (msec)",
                        "criterion": "Fridericia's corrected QT (QTcF) interval",
                        "requirement": {
                            "requirement_type": "prolongation",
                            "expected_value": {
                                "operator": ">",
                                "value": 480,
                                "unit": "milliseconds"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of hypersensitivity reaction by liposomal formulation agent",
                "criterions": [
                    {
                        "exact_snippets": "History of hypersensitivity reaction by liposomal formulation agent",
                        "criterion": "hypersensitivity reaction",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of hypersensitivity reaction by liposomal formulation agent",
                        "criterion": "hypersensitivity reaction",
                        "requirement": {
                            "requirement_type": "cause",
                            "expected_value": "liposomal formulation agent"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "History of hypersensitivity reaction by liposomal formulation agent",
                        "criterion": "hypersensitivity reaction",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of hypersensitivity reaction by liposomal formulation agent",
                        "criterion": "hypersensitivity reaction",
                        "requirement": {
                            "requirement_type": "cause",
                            "expected_value": "liposomal formulation agent"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Major surgery within 21 days prior to starting study drug",
                "criterions": [
                    {
                        "exact_snippets": "Major surgery within 21 days prior to starting study drug",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Major surgery within 21 days prior to starting study drug",
                    "criterion": "major surgery",
                    "requirement": {
                        "requirement_type": "time since",
                        "expected_value": {
                            "operator": "<=",
                            "value": 21,
                            "unit": "days"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Previous treatment with eribulin",
                "criterions": [
                    {
                        "exact_snippets": "Previous treatment with eribulin",
                        "criterion": "treatment with eribulin",
                        "requirement": {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Previous treatment with eribulin",
                    "criterion": "treatment with eribulin",
                    "requirement": {
                        "requirement_type": "previous treatment",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Previous radiation therapy encompassing an extensive region including the bone marrow (example, >30% of bone marrow)",
                "criterions": [
                    {
                        "exact_snippets": "Previous radiation therapy encompassing an extensive region including the bone marrow",
                        "criterion": "previous radiation therapy",
                        "requirement": {
                            "requirement_type": "extent",
                            "expected_value": "encompassing an extensive region including the bone marrow"
                        }
                    },
                    {
                        "exact_snippets": "example, >30% of bone marrow",
                        "criterion": "bone marrow radiation",
                        "requirement": {
                            "requirement_type": "extent",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "% of bone marrow"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Previous radiation therapy encompassing an extensive region including the bone marrow",
                                "criterion": "previous radiation therapy",
                                "requirement": {
                                    "requirement_type": "extent",
                                    "expected_value": "encompassing an extensive region including the bone marrow"
                                }
                            },
                            {
                                "exact_snippets": "example, >30% of bone marrow",
                                "criterion": "bone marrow radiation",
                                "requirement": {
                                    "requirement_type": "extent",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 30,
                                        "unit": "% of bone marrow"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Known intolerance to the study drug or any of the excipients",
                "criterions": [
                    {
                        "exact_snippets": "Known intolerance to the study drug",
                        "criterion": "intolerance to the study drug",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "intolerance to ... any of the excipients",
                        "criterion": "intolerance to excipients",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Known intolerance to the study drug",
                        "criterion": "intolerance to the study drug",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "intolerance to ... any of the excipients",
                        "criterion": "intolerance to excipients",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Known to be human immunodeficiency virus (HIV) positive",
                "criterions": [
                    {
                        "exact_snippets": "Known to be human immunodeficiency virus (HIV) positive",
                        "criterion": "HIV status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Known to be human immunodeficiency virus (HIV) positive",
                    "criterion": "HIV status",
                    "requirement": {
                        "requirement_type": "status",
                        "expected_value": "positive"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Active viral hepatitis (B or C) as demonstrated by positive serology or requiring treatment",
                "criterions": [
                    {
                        "exact_snippets": "Active viral hepatitis (B or C)",
                        "criterion": "active viral hepatitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "positive serology",
                        "criterion": "positive serology for hepatitis B or C",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "requiring treatment",
                        "criterion": "treatment requirement for hepatitis B or C",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Active viral hepatitis (B or C)",
                                "criterion": "active viral hepatitis",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "positive serology",
                                "criterion": "positive serology for hepatitis B or C",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "requiring treatment",
                        "criterion": "treatment requirement for hepatitis B or C",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Diagnosed with meningeal carcinomatosis",
                "criterions": [
                    {
                        "exact_snippets": "Diagnosed with meningeal carcinomatosis",
                        "criterion": "meningeal carcinomatosis",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Diagnosed with meningeal carcinomatosis",
                    "criterion": "meningeal carcinomatosis",
                    "requirement": {
                        "requirement_type": "diagnosis",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Participants with brain or subdural metastases or invasion are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (example, radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment.",
                "criterions": [
                    {
                        "exact_snippets": "brain or subdural metastases or invasion",
                        "criterion": "brain or subdural metastases or invasion",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "completed local therapy",
                        "criterion": "local therapy completion",
                        "requirement": {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "discontinued the use of corticosteroids for this indication for at least 4 weeks",
                        "criterion": "corticosteroid use",
                        "requirement": {
                            "requirement_type": "discontinuation duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "signs (example, radiologic) or symptoms of brain metastases must be stable for at least 4 weeks",
                        "criterion": "stability of brain metastases signs or symptoms",
                        "requirement": {
                            "requirement_type": "stability duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
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                        {
                            "and_criteria": [
                                {
                                    "and_criteria": [
                                        {
                                            "and_criteria": [
                                                {
                                                    "exact_snippets": "brain or subdural metastases or invasion",
                                                    "criterion": "brain or subdural metastases or invasion",
                                                    "requirement": {
                                                        "requirement_type": "presence",
                                                        "expected_value": true
                                                    }
                                                },
                                                {
                                                    "exact_snippets": "completed local therapy",
                                                    "criterion": "local therapy completion",
                                                    "requirement": {
                                                        "requirement_type": "completion",
                                                        "expected_value": true
                                                    }
                                                }
                                            ]
                                        },
                                        {
                                            "exact_snippets": "discontinued the use of corticosteroids for this indication for at least 4 weeks",
                                            "criterion": "corticosteroid use",
                                            "requirement": {
                                                "requirement_type": "discontinuation duration",
                                                "expected_value": {
                                                    "operator": ">=",
                                                    "value": 4,
                                                    "unit": "weeks"
                                                }
                                            }
                                        }
                                    ]
                                },
                                {
                                    "exact_snippets": "signs (example, radiologic) or symptoms of brain metastases must be stable for at least 4 weeks",
                                    "criterion": "stability of brain metastases signs or symptoms",
                                    "requirement": {
                                        "requirement_type": "stability duration",
                                        "expected_value": {
                                            "operator": ">=",
                                            "value": 4,
                                            "unit": "weeks"
                                        }
                                    }
                                }
                            ]
                        }
                    ]
                },
                "then_criteria": null,
                "else_criteria": {
                    "exact_snippets": "brain or subdural metastases or invasion",
                    "criterion": "brain or subdural metastases or invasion",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.",
                "criterions": [
                    {
                        "exact_snippets": "Pulmonary lymphangitic involvement",
                        "criterion": "pulmonary lymphangitic involvement",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "pulmonary dysfunction requiring active treatment",
                        "criterion": "pulmonary dysfunction",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "requiring active treatment"
                        }
                    },
                    {
                        "exact_snippets": "use of oxygen",
                        "criterion": "use of oxygen",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Pulmonary lymphangitic involvement",
                                "criterion": "pulmonary lymphangitic involvement",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "pulmonary dysfunction requiring active treatment",
                                "criterion": "pulmonary dysfunction",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "requiring active treatment"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "use of oxygen",
                        "criterion": "use of oxygen",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Expansion-part only: history of active malignancy (except for primary tumor, or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, carcinoma in-situ of the bladder or cervix, or early stage gastric/colorectal cancer) within the past 24 months prior to the first dose of study drug",
                "criterions": [
                    {
                        "exact_snippets": "history of active malignancy (except for primary tumor, or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, carcinoma in-situ of the bladder or cervix, or early stage gastric/colorectal cancer)",
                        "criterion": "active malignancy",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "within the past 24 months prior to the first dose of study drug",
                        "criterion": "time since last active malignancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 24,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "exact_snippets": "history of active malignancy (except for primary tumor, or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, carcinoma in-situ of the bladder or cervix, or early stage gastric/colorectal cancer)",
                            "criterion": "active malignancy",
                            "requirement": {
                                "requirement_type": "history",
                                "expected_value": true
                            }
                        },
                        {
                            "exact_snippets": "within the past 24 months prior to the first dose of study drug",
                            "criterion": "time since last active malignancy",
                            "requirement": {
                                "requirement_type": "duration",
                                "expected_value": {
                                    "operator": "<=",
                                    "value": 24,
                                    "unit": "months"
                                }
                            }
                        }
                    ]
                },
                "then_criteria": {
                    "not_criteria": {
                        "or_criteria": [
                            {
                                "exact_snippets": "history of active malignancy (except for primary tumor, or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, carcinoma in-situ of the bladder or cervix, or early stage gastric/colorectal cancer)",
                                "criterion": "active malignancy",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "within the past 24 months prior to the first dose of study drug",
                                "criterion": "time since last active malignancy",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 24,
                                        "unit": "months"
                                    }
                                }
                            }
                        ]
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Males with impregnate potential or females of childbearing potential who or whose partner do not agree with medically effective method of contraception throughout the entire study period and for 28 days (90 days for male) after study drug discontinuation",
                "criterions": [
                    {
                        "exact_snippets": "Males with impregnate potential",
                        "criterion": "male impregnate potential",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "females of childbearing potential",
                        "criterion": "female childbearing potential",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "do not agree with medically effective method of contraception",
                        "criterion": "agreement with medically effective method of contraception",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "throughout the entire study period and for 28 days (90 days for male) after study drug discontinuation",
                        "criterion": "duration of contraception",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "entire study period and for 28 days (90 days for male) after study drug discontinuation"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "Males with impregnate potential",
                                                "criterion": "male impregnate potential",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": true
                                                }
                                            },
                                            {
                                                "exact_snippets": "do not agree with medically effective method of contraception",
                                                "criterion": "agreement with medically effective method of contraception",
                                                "requirement": {
                                                    "requirement_type": "agreement",
                                                    "expected_value": false
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "throughout the entire study period and for 28 days (90 days for male) after study drug discontinuation",
                                        "criterion": "duration of contraception",
                                        "requirement": {
                                            "requirement_type": "duration",
                                            "expected_value": "entire study period and for 28 days (90 days for male) after study drug discontinuation"
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "females of childbearing potential",
                                                "criterion": "female childbearing potential",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": true
                                                }
                                            },
                                            {
                                                "exact_snippets": "do not agree with medically effective method of contraception",
                                                "criterion": "agreement with medically effective method of contraception",
                                                "requirement": {
                                                    "requirement_type": "agreement",
                                                    "expected_value": false
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "throughout the entire study period and for 28 days (90 days for male) after study drug discontinuation",
                                        "criterion": "duration of contraception",
                                        "requirement": {
                                            "requirement_type": "duration",
                                            "expected_value": "entire study period and for 28 days (90 days for male) after study drug discontinuation"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Ex-part 6 only: Active or acute oral infection requiring dental treatment",
                "criterions": [
                    {
                        "exact_snippets": "Active or acute oral infection requiring dental treatment",
                        "criterion": "oral infection",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "acute"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Active or acute oral infection requiring dental treatment",
                        "criterion": "oral infection",
                        "requirement": {
                            "requirement_type": "treatment necessity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Active or acute oral infection requiring dental treatment",
                                "criterion": "oral infection",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": [
                                        "active",
                                        "acute"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "Active or acute oral infection requiring dental treatment",
                                "criterion": "oral infection",
                                "requirement": {
                                    "requirement_type": "treatment necessity",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Ex-part 6 only",
                        "criterion": "part",
                        "requirement": {
                            "requirement_type": "inclusion",
                            "expected_value": "6"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Ex-part 6 only: Participants who received taxanes as neoadjuvant or adjuvant chemotherapy and have radiographically progressive disease by investigator(s) decision within 12 months after the last dose of taxane",
                "criterions": [
                    {
                        "exact_snippets": "Participants who received taxanes as neoadjuvant or adjuvant chemotherapy",
                        "criterion": "taxane chemotherapy",
                        "requirement": {
                            "requirement_type": "treatment type",
                            "expected_value": [
                                "neoadjuvant",
                                "adjuvant"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "radiographically progressive disease",
                        "criterion": "progressive disease",
                        "requirement": {
                            "requirement_type": "detection method",
                            "expected_value": "radiographic"
                        }
                    },
                    {
                        "exact_snippets": "progressive disease ... within 12 months after the last dose of taxane",
                        "criterion": "progressive disease timing",
                        "requirement": {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Participants who received taxanes as neoadjuvant or adjuvant chemotherapy",
                                "criterion": "taxane chemotherapy",
                                "requirement": {
                                    "requirement_type": "treatment type",
                                    "expected_value": [
                                        "neoadjuvant",
                                        "adjuvant"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "radiographically progressive disease",
                                "criterion": "progressive disease",
                                "requirement": {
                                    "requirement_type": "detection method",
                                    "expected_value": "radiographic"
                                }
                            },
                            {
                                "exact_snippets": "progressive disease ... within 12 months after the last dose of taxane",
                                "criterion": "progressive disease timing",
                                "requirement": {
                                    "requirement_type": "time since last dose",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 12,
                                        "unit": "months"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Ex-part 6 only: Child-Pugh score B or C",
                "criterions": [
                    {
                        "exact_snippets": "Child-Pugh score B or C",
                        "criterion": "Child-Pugh score",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": [
                                "B",
                                "C"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Ex-part 6 only",
                                "criterion": "Ex-part 6",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Child-Pugh score B or C",
                                "criterion": "Child-Pugh score",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": [
                                        "B",
                                        "C"
                                    ]
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Participants with advanced, nonresectable, or recurrent solid tumor for which no alternative standard therapy or no effective therapy exists",
                "criterions": [
                    {
                        "exact_snippets": "advanced, nonresectable, or recurrent solid tumor",
                        "criterion": "solid tumor",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "advanced",
                                "nonresectable",
                                "recurrent"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "no alternative standard therapy or no effective therapy exists",
                        "criterion": "availability of alternative or effective therapy",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "advanced, nonresectable, or recurrent solid tumor",
                                "criterion": "solid tumor",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": "advanced"
                                }
                            },
                            {
                                "exact_snippets": "advanced, nonresectable, or recurrent solid tumor",
                                "criterion": "solid tumor",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": "nonresectable"
                                }
                            },
                            {
                                "exact_snippets": "advanced, nonresectable, or recurrent solid tumor",
                                "criterion": "solid tumor",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": "recurrent"
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "no alternative standard therapy or no effective therapy exists",
                                "criterion": "availability of alternative or effective therapy",
                                "requirement": {
                                    "requirement_type": "availability",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Ex-part 6 only: breast cancer with confirmed diagnosis, HER2 negative (IHC 0/1+, or FISH negative) and without prior chemotherapy regimens to advanced or metastatic disease. Participants with triple-negative breast cancer (TNBC) who are PD-L1 negative as assessed by the site or who are medically determined by the investigator(s) to be ineligible for treatment with atezolizumab and other immune-checkpoint inhibitors will be included.",
                "criterions": [
                    {
                        "exact_snippets": "breast cancer with confirmed diagnosis",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": "confirmed"
                        }
                    },
                    {
                        "exact_snippets": "HER2 negative (IHC 0/1+, or FISH negative)",
                        "criterion": "HER2 status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "without prior chemotherapy regimens to advanced or metastatic disease",
                        "criterion": "prior chemotherapy regimens",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "triple-negative breast cancer (TNBC)",
                        "criterion": "triple-negative breast cancer (TNBC)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "PD-L1 negative as assessed by the site",
                        "criterion": "PD-L1 status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "medically determined by the investigator(s) to be ineligible for treatment with atezolizumab and other immune-checkpoint inhibitors",
                        "criterion": "eligibility for treatment with atezolizumab and other immune-checkpoint inhibitors",
                        "requirement": {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Life expectancy of greater than or equal to (>=) 12 weeks",
                "criterions": [
                    {
                        "exact_snippets": "Life expectancy of greater than or equal to (>=) 12 weeks",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Eastern Cooperative Oncology Group-Performance Status (ECOG-PS) of 0 to 1",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group-Performance Status (ECOG-PS) of 0 to 1",
                        "criterion": "Eastern Cooperative Oncology Group-Performance Status (ECOG-PS)",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Japanese participants aged >=20 years at the time of informed consent",
                "criterions": [
                    {
                        "exact_snippets": "Japanese participants",
                        "criterion": "ethnicity",
                        "requirement": {
                            "requirement_type": "ethnicity",
                            "expected_value": "Japanese"
                        }
                    },
                    {
                        "exact_snippets": "aged >=20 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* All adverse events (AEs) due to previous anti-cancer therapy have either returned to Grade 0 or 1 except for alopecia and Grade 2 peripheral neuropathy",
                "criterions": [
                    {
                        "exact_snippets": "All adverse events (AEs) due to previous anti-cancer therapy have either returned to Grade 0 or 1",
                        "criterion": "adverse events due to previous anti-cancer therapy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": [
                                "Grade 0",
                                "Grade 1"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "except for alopecia",
                        "criterion": "alopecia",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "any"
                        }
                    },
                    {
                        "exact_snippets": "except for ... Grade 2 peripheral neuropathy",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "Grade 2"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Total bilirubin <=1.5 × upper limit of normal (ULN) except for unconjugated hyperbilirubinemia or Gilbert's syndrome",
                "criterions": [
                    {
                        "exact_snippets": "Total bilirubin <=1.5 × upper limit of normal (ULN)",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "except for unconjugated hyperbilirubinemia",
                        "criterion": "unconjugated hyperbilirubinemia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "except for ... Gilbert's syndrome",
                        "criterion": "Gilbert's syndrome",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "exact_snippets": "unconjugated hyperbilirubinemia",
                            "criterion": "unconjugated hyperbilirubinemia",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        },
                        {
                            "exact_snippets": "except for ... Gilbert's syndrome",
                            "criterion": "Gilbert's syndrome",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    ]
                },
                "then_criteria": {
                    "exact_snippets": "Total bilirubin <=1.5 × upper limit of normal (ULN)",
                    "criterion": "total bilirubin",
                    "requirement": {
                        "requirement_type": "level",
                        "expected_value": {
                            "operator": "<=",
                            "value": 1.5,
                            "unit": "× ULN"
                        }
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) <=3 × ULN (<=5.0 times ULN in the participants with liver metastases)",
                "criterions": [
                    {
                        "exact_snippets": "Alkaline phosphatase ... <=3 × ULN (<=5.0 times ULN in the participants with liver metastases)",
                        "criterion": "alkaline phosphatase",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "ULN"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "alanine aminotransferase (ALT) ... <=3 × ULN (<=5.0 times ULN in the participants with liver metastases)",
                        "criterion": "alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "ULN"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "aspartate aminotransferase (AST) <=3 × ULN (<=5.0 times ULN in the participants with liver metastases)",
                        "criterion": "aspartate aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "ULN"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "condition": {
                            "exact_snippets": "liver metastases",
                            "criterion": "liver metastases",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        },
                        "then_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Alkaline phosphatase ... <=3 × ULN (<=5.0 times ULN in the participants with liver metastases)",
                                    "criterion": "alkaline phosphatase",
                                    "requirement": {
                                        "requirement_type": "level",
                                        "expected_value": {
                                            "comparisons": [
                                                {
                                                    "operator": "<=",
                                                    "value": 5,
                                                    "unit": "ULN"
                                                }
                                            ]
                                        }
                                    }
                                },
                                {
                                    "exact_snippets": "alanine aminotransferase (ALT) ... <=3 × ULN (<=5.0 times ULN in the participants with liver metastases)",
                                    "criterion": "alanine aminotransferase (ALT)",
                                    "requirement": {
                                        "requirement_type": "level",
                                        "expected_value": {
                                            "comparisons": [
                                                {
                                                    "operator": "<=",
                                                    "value": 5,
                                                    "unit": "ULN"
                                                }
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                                    }
                                },
                                {
                                    "exact_snippets": "aspartate aminotransferase (AST) <=3 × ULN (<=5.0 times ULN in the participants with liver metastases)",
                                    "criterion": "aspartate aminotransferase (AST)",
                                    "requirement": {
                                        "requirement_type": "level",
                                        "expected_value": {
                                            "comparisons": [
                                                {
                                                    "operator": "<=",
                                                    "value": 5,
                                                    "unit": "ULN"
                                                }
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                                        }
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                            ]
                        },
                        "else_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Alkaline phosphatase ... <=3 × ULN (<=5.0 times ULN in the participants with liver metastases)",
                                    "criterion": "alkaline phosphatase",
                                    "requirement": {
                                        "requirement_type": "level",
                                        "expected_value": {
                                            "comparisons": [
                                                {
                                                    "operator": "<=",
                                                    "value": 3,
                                                    "unit": "ULN"
                                                }
                                            ]
                                        }
                                    }
                                },
                                {
                                    "exact_snippets": "alanine aminotransferase (ALT) ... <=3 × ULN (<=5.0 times ULN in the participants with liver metastases)",
                                    "criterion": "alanine aminotransferase (ALT)",
                                    "requirement": {
                                        "requirement_type": "level",
                                        "expected_value": {
                                            "comparisons": [
                                                {
                                                    "operator": "<=",
                                                    "value": 3,
                                                    "unit": "ULN"
                                                }
                                            ]
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                                    }
                                },
                                {
                                    "exact_snippets": "aspartate aminotransferase (AST) <=3 × ULN (<=5.0 times ULN in the participants with liver metastases)",
                                    "criterion": "aspartate aminotransferase (AST)",
                                    "requirement": {
                                        "requirement_type": "level",
                                        "expected_value": {
                                            "comparisons": [
                                                {
                                                    "operator": "<=",
                                                    "value": 3,
                                                    "unit": "ULN"
                                                }
                                            ]
                                        }
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Evidence of clinically significant disease/status (example, cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments",
                "criterions": [
                    {
                        "exact_snippets": "clinically significant disease/status (example, cardiac, respiratory, gastrointestinal, renal disease)",
                        "criterion": "clinically significant disease/status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments",
                        "criterion": "investigator's opinion on safety/interference",
                        "requirement": {
                            "requirement_type": "impact",
                            "expected_value": "not affect safety or interfere with assessments"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "clinically significant disease/status (example, cardiac, respiratory, gastrointestinal, renal disease)",
                                "criterion": "clinically significant disease/status",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments",
                                "criterion": "investigator's opinion on safety/interference",
                                "requirement": {
                                    "requirement_type": "impact",
                                    "expected_value": "affect safety or interfere with assessments"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [β-hCG] or hCG test). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.",
                "criterions": [
                    {
                        "exact_snippets": "Females who are breastfeeding",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [β-hCG] or hCG test)",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Females who are breastfeeding",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [β-hCG] or hCG test)",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}