{
    "info": {
        "nct_id": "NCT06042894",
        "official_title": "A Phase II Clinical Trial to Evaluate the Efficacy and Safety of SI-B003 Monotherapy or BL-B01D1+SI-B003 Combination Therapy (BL-B01D1+SI-B003) in Patients With Unresectable Locally Advanced or Recurrent Metastatic HER2 Negative Breast Cancer",
        "inclusion_criteria": "1. Voluntarily sign the informed consent and follow the requirements of the protocol.\n2. Age: ≥18 years old and ≤75 years old.\n3. Expected survival time ≥3 months.\n4. ECOG 0 or 1.\n5. Pathologically and/or cytologically confirmed patients who have failed standard treatment, or have no access to standard treatment Patients with unresectable, locally advanced or recurrent, metastatic HER2-negative breast cancer after posterior line.\n6. Agree to provide archived tumor tissue specimens (unstained sections (anti-slip)) from primary or metastatic sites within 2 years. 10 to 12 surgical specimens (4-5 μm thick) or fresh tissue samples if the subject is unable to provide them for 2 years tumor tissue samples from within, can be communicated with the sponsor if other inclusion criteria are met, enrollment was permitted after investigator assessment.\n7. Must have at least one measurable lesion according to RECIST v1.1 definition; So let's say that we've done this before radiotherapy-treated lesions were included only if there was definite disease progression in the lesion after radiotherapy measurable lesions were entered.\n8. Blood transfusions, the use of any cell growth factors, and/or blood transfusions were not allowed within 14 days before screening in the presence of a platelet drug, the organ function level must meet the following criteria:\n\n   1. Blood routine: hemoglobin (HGB) ≥ 90g/L; Absolute neutrophil count (NEUT) ≥ 1.5× 10 9 /L; Platelet count (PLT) ≥ 90× 10 9 /L;\n   2. Renal function: creatinine (Cr) ≤1.5 ULN, or creatinine clearance (Ccr) ≥50 mL/min (According to Cockcroft and Gault formula);\n   3. Liver function: total bilirubin (TBIL≤1.5 ULN), alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) was ≤2.5 ULN in all patients, and AST and ALT were ≤ in patients with liver metastasis 5.0 ULN;\n   4. Coagulation function: international normalized ratio (INR) ≤1.5 and activated partial thromboplastin time (APTT) ≤1.5ULN;\n   5. no severe cardiac dysfunction with left ventricular ejection fraction ≥50%;\n   6. proteinuria ≤2+ or ≤1000mg/24h.\n9. Toxicity from previous antineoplastic therapy has returned to grade 1 or less as defined by NCI-CTCAE v5.0 (investigator review) concerns about asymptomatic laboratory abnormalities such as elevated ALP, hyperuricemia, hyperglycemia, etc., and investigators toxicity without safety risk was judged, such as alopecia, grade 2 peripheral neurotoxicity, or decreased hemoglobin but ≥90g/L except).\n10. A pregnancy test should be performed within 7 days of starting treatment for premenopausal women who are likely to have children clear or urine pregnancy tests must be negative and must be non-lactating; All enrolled patients should be in the entire treatment week adequate barrier contraceptive measures were taken at the end of treatment and 6 months after the end of treatment.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. ADC drugs that have received topoisomerase I inhibitors (camptothecins) as small molecule toxins.\n2. Administration of chemotherapy or chemotherapy within 4 weeks or 5 half-lives, whichever is shorter, before the first dose physical therapy, immunotherapy, definitive radiotherapy, major surgery (investigator's definition), targeted therapy (including minor) molecular tyrosine kinase inhibitors) and other anti-tumor therapy; Oral fluorouracil drugs such as S-1, carboplatin ecitabine or palliative radiotherapy within 2 weeks before the first dose.\n3. Use of immunomodulatory drugs within 14 days before the first use of the study drug: including but not limited to thymosin, interleukin-2, interferon, etc.\n4. Systemic corticosteroids (> 10mg/ day prednisone, or other corticosteroids in equivalent amounts); Inhaled or topical administration of hormones, or received physiology for adrenal insufficiency alternative doses of hormone therapy were excluded.\n5. Patients with grade ≥3 irAE or grade ≥2 immune-related myocarditis who had received immunotherapy were excluded.\n6. A history of severe cardiovascular and cerebrovascular diseases, including but not limited to:\n\n   1. severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias or grade III atria requiring clinical intervention Ventricular block;\n   2. prolonged QT interval at rest (QTc > 450 msec in men or QTc > 470 msec in women);\n   3. myocardial infarction, unstable angina, cardiac angioplasty, or within 6 months before the first dose Stent implantation, coronary artery/peripheral artery bypass grafting, New York Heart Association Defined class III or IV congestive heart failure, cerebrovascular accident, or transient ischemic attack.\n7. Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, silver requiring systemic treatment dandruptitis, rheumatoid arthritis, inflammatory bowel disease and hashimoto's thyroiditis, except type I diabetes, hypothyroidism that can be controlled only by replacement therapy, skin diseases that do not require systemic treatment (e.g., vitiligo, silver) Dandruff).\n8. Other malignancies that progressed or required treatment within 3 years before the first dose, such as the following external: radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or radical carcinoma in situ.\n9. History or current history of (noninfectious) interstitial lung disease (ILD)/pulmonary inflammation requiring steroid therapy patients with ILD/ pulmonary inflammation, or suspected ILD/ pulmonary inflammation that cannot be excluded by imaging at the time of screening.\n10. Prior to starting the study treatment, there are:\n\n    1. Poorly controlled diabetes (fasting blood glucose ≥ 13.3 mmol/L)\n    2. Poorly controlled hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg)\n    3. History of hypertensive crisis or hypertensive encephalopathy.\n11. Unstable deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring medical intervention within 6 months before screening thrombotic events such as plug; Infusion-related thrombosis was excluded.\n12. Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis (meningeal metastases). Patients who had received treatment for brain metastases (radiotherapy or surgery; Patients with stable brain metastases who had stopped radiotherapy or surgery 28 days before the first dose were eligible. Patients with cancerous meningitis (meningeal metastasis) were excluded even if they were treated and judged to be stable. Stability is defined as meeting the following four criteria:\n\n    1. seizure-free status for > 12 weeks with or without antiepileptic medication;\n    2. no need for corticosteroids;\n    3. stable on two consecutive MRI scans (at least 4 weeks apart);\n    4. stable and asymptomatic for more than one month after treatment.\n13. Patients with pleural effusion, pericardial effusion or ascites with clinical symptoms or requiring repeated drainage.\n14. Allergic history to recombinant humanized antibody or human-mouse chimeric antibody or any excipients of BL-B01D1 sensitive patients.\n15. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT).\n16. Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, or active hepatitis C virus infection (HCV antibody positive and HCV-RNA > lower detection limit).\n17. Positive hepatitis B surface antigen (HBsAg) and HBV DNA> 500IU/ml or 2000 copies /ml patients with HBV infection should receive antiviral treatment according to local treatment guidelines and be willing to participate in the study all patients received antiviral therapy during the whole period.\n18. Active infection requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.\n19. Had participated in another clinical trial within 4 weeks before the first dose (calculated from the time of last dose).\n20. Persons with a history of psychotropic drug abuse and inability to quit or mental disorders.\n21. Any other circumstances that the investigator deemed inappropriate for participation in the trial.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. Voluntarily sign the informed consent and follow the requirements of the protocol.",
                "criterions": [
                    {
                        "exact_snippets": "Voluntarily sign the informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "follow the requirements of the protocol",
                        "criterion": "protocol adherence",
                        "requirement": {
                            "requirement_type": "adherence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Voluntarily sign the informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "follow the requirements of the protocol",
                        "criterion": "protocol adherence",
                        "requirement": {
                            "requirement_type": "adherence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Age: ≥18 years old and ≤75 years old.",
                "criterions": [
                    {
                        "exact_snippets": "Age: ≥18 years old and ≤75 years old.",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age: ≥18 years old and ≤75 years old.",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Expected survival time ≥3 months.",
                "criterions": [
                    {
                        "exact_snippets": "Expected survival time ≥3 months",
                        "criterion": "expected survival time",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Expected survival time ≥3 months",
                        "criterion": "expected survival time",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Must have at least one measurable lesion according to RECIST v1.1 definition; So let's say that we've done this before radiotherapy-treated lesions were included only if there was definite disease progression in the lesion after radiotherapy measurable lesions were entered.",
                "criterions": [
                    {
                        "exact_snippets": "at least one measurable lesion according to RECIST v1.1 definition",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "at least one measurable lesion according to RECIST v1.1 definition",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "definition",
                            "expected_value": "RECIST v1.1"
                        }
                    },
                    {
                        "exact_snippets": "radiotherapy-treated lesions were included only if there was definite disease progression in the lesion after radiotherapy",
                        "criterion": "radiotherapy-treated lesions",
                        "requirement": {
                            "requirement_type": "disease progression",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "at least one measurable lesion according to RECIST v1.1 definition",
                                "criterion": "measurable lesion",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "at least one measurable lesion according to RECIST v1.1 definition",
                                "criterion": "measurable lesion",
                                "requirement": {
                                    "requirement_type": "definition",
                                    "expected_value": "RECIST v1.1"
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "radiotherapy-treated lesions were included only if there was definite disease progression in the lesion after radiotherapy",
                                "criterion": "radiotherapy-treated lesions",
                                "requirement": {
                                    "requirement_type": "disease progression",
                                    "expected_value": true
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "radiotherapy-treated lesions were included only if there was definite disease progression in the lesion after radiotherapy",
                                    "criterion": "radiotherapy-treated lesions",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Blood transfusions, the use of any cell growth factors, and/or blood transfusions were not allowed within 14 days before screening in the presence of a platelet drug, the organ function level must meet the following criteria:",
                "criterions": [
                    {
                        "exact_snippets": "Blood transfusions ... were not allowed within 14 days before screening",
                        "criterion": "blood transfusions",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<",
                                "value": 14,
                                "unit": "days before screening"
                            }
                        }
                    },
                    {
                        "exact_snippets": "the use of any cell growth factors ... were not allowed within 14 days before screening",
                        "criterion": "use of cell growth factors",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<",
                                "value": 14,
                                "unit": "days before screening"
                            }
                        }
                    },
                    {
                        "exact_snippets": "blood transfusions were not allowed within 14 days before screening",
                        "criterion": "blood transfusions",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<",
                                "value": 14,
                                "unit": "days before screening"
                            }
                        }
                    },
                    {
                        "exact_snippets": "in the presence of a platelet drug",
                        "criterion": "presence of a platelet drug",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "the organ function level must meet the following criteria",
                        "criterion": "organ function level",
                        "requirement": {
                            "requirement_type": "criteria",
                            "expected_value": "must meet the following criteria"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "or_criteria": [
                                {
                                    "and_criteria": [
                                        {
                                            "exact_snippets": "Blood transfusions ... were not allowed within 14 days before screening",
                                            "criterion": "blood transfusions",
                                            "requirement": {
                                                "requirement_type": "timing",
                                                "expected_value": {
                                                    "operator": "<",
                                                    "value": 14,
                                                    "unit": "days before screening"
                                                }
                                            }
                                        },
                                        {
                                            "exact_snippets": "the use of any cell growth factors ... were not allowed within 14 days before screening",
                                            "criterion": "use of cell growth factors",
                                            "requirement": {
                                                "requirement_type": "timing",
                                                "expected_value": {
                                                    "operator": "<",
                                                    "value": 14,
                                                    "unit": "days before screening"
                                                }
                                            }
                                        }
                                    ]
                                },
                                {
                                    "exact_snippets": "blood transfusions were not allowed within 14 days before screening",
                                    "criterion": "blood transfusions",
                                    "requirement": {
                                        "requirement_type": "timing",
                                        "expected_value": {
                                            "operator": "<",
                                            "value": 14,
                                            "unit": "days before screening"
                                        }
                                    }
                                }
                            ]
                        }
                    ]
                },
                "then_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "in the presence of a platelet drug",
                            "criterion": "presence of a platelet drug",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        },
                        {
                            "exact_snippets": "the organ function level must meet the following criteria",
                            "criterion": "organ function level",
                            "requirement": {
                                "requirement_type": "criteria",
                                "expected_value": "must meet the following criteria"
                            }
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "1. Blood routine: hemoglobin (HGB) ≥ 90g/L; Absolute neutrophil count (NEUT) ≥ 1.5× 10 9 /L; Platelet count (PLT) ≥ 90× 10 9 /L;",
                "criterions": [
                    {
                        "exact_snippets": "hemoglobin (HGB) ≥ 90g/L",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Absolute neutrophil count (NEUT) ≥ 1.5× 10 9 /L",
                        "criterion": "absolute neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "× 10 9 /L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Platelet count (PLT) ≥ 90× 10 9 /L",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "× 10 9 /L"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "hemoglobin (HGB) ≥ 90g/L",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Absolute neutrophil count (NEUT) ≥ 1.5× 10 9 /L",
                        "criterion": "absolute neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "× 10 9 /L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Platelet count (PLT) ≥ 90× 10 9 /L",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "× 10 9 /L"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Renal function: creatinine (Cr) ≤1.5 ULN, or creatinine clearance (Ccr) ≥50 mL/min (According to Cockcroft and Gault formula);",
                "criterions": [
                    {
                        "exact_snippets": "creatinine (Cr) ≤1.5 ULN",
                        "criterion": "creatinine level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "creatinine clearance (Ccr) ≥50 mL/min",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "clearance",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "creatinine (Cr) ≤1.5 ULN",
                                "criterion": "creatinine level",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "ULN"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "creatinine clearance (Ccr) ≥50 mL/min",
                                "criterion": "creatinine clearance",
                                "requirement": {
                                    "requirement_type": "clearance",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 50,
                                        "unit": "mL/min"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. no severe cardiac dysfunction with left ventricular ejection fraction ≥50%;",
                "criterions": [
                    {
                        "exact_snippets": "no severe cardiac dysfunction",
                        "criterion": "cardiac dysfunction",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "not severe"
                        }
                    },
                    {
                        "exact_snippets": "left ventricular ejection fraction ≥50%",
                        "criterion": "left ventricular ejection fraction",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "no severe cardiac dysfunction",
                        "criterion": "cardiac dysfunction",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "not severe"
                        }
                    },
                    {
                        "exact_snippets": "left ventricular ejection fraction ≥50%",
                        "criterion": "left ventricular ejection fraction",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. Toxicity from previous antineoplastic therapy has returned to grade 1 or less as defined by NCI-CTCAE v5.0 (investigator review) concerns about asymptomatic laboratory abnormalities such as elevated ALP, hyperuricemia, hyperglycemia, etc., and investigators toxicity without safety risk was judged, such as alopecia, grade 2 peripheral neurotoxicity, or decreased hemoglobin but ≥90g/L except).",
                "criterions": [
                    {
                        "exact_snippets": "Toxicity from previous antineoplastic therapy has returned to grade 1 or less",
                        "criterion": "toxicity from previous antineoplastic therapy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "asymptomatic laboratory abnormalities such as elevated ALP, hyperuricemia, hyperglycemia",
                        "criterion": "asymptomatic laboratory abnormalities",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "elevated ALP",
                                "hyperuricemia",
                                "hyperglycemia"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "investigators toxicity without safety risk was judged, such as alopecia, grade 2 peripheral neurotoxicity, or decreased hemoglobin but ≥90g/L",
                        "criterion": "investigator's judged toxicity without safety risk",
                        "requirement": {
                            "requirement_type": "examples",
                            "expected_value": [
                                "alopecia",
                                "grade 2 peripheral neurotoxicity",
                                "decreased hemoglobin but ≥90g/L"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Toxicity from previous antineoplastic therapy has returned to grade 1 or less",
                                "criterion": "toxicity from previous antineoplastic therapy",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "grade"
                                    }
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "asymptomatic laboratory abnormalities such as elevated ALP, hyperuricemia, hyperglycemia",
                                    "criterion": "asymptomatic laboratory abnormalities",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": [
                                            "elevated ALP",
                                            "hyperuricemia",
                                            "hyperglycemia"
                                        ]
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "investigators toxicity without safety risk was judged, such as alopecia, grade 2 peripheral neurotoxicity, or decreased hemoglobin but ≥90g/L",
                        "criterion": "investigator's judged toxicity without safety risk",
                        "requirement": {
                            "requirement_type": "examples",
                            "expected_value": [
                                "alopecia",
                                "grade 2 peripheral neurotoxicity",
                                "decreased hemoglobin but ≥90g/L"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "10. A pregnancy test should be performed within 7 days of starting treatment for premenopausal women who are likely to have children clear or urine pregnancy tests must be negative and must be non-lactating; All enrolled patients should be in the entire treatment week adequate barrier contraceptive measures were taken at the end of treatment and 6 months after the end of treatment.",
                "criterions": [
                    {
                        "exact_snippets": "pregnancy test should be performed within 7 days of starting treatment",
                        "criterion": "pregnancy test timing",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days of starting treatment"
                        }
                    },
                    {
                        "exact_snippets": "premenopausal women who are likely to have children",
                        "criterion": "premenopausal status",
                        "requirement": {
                            "requirement_type": "likelihood of having children",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "clear or urine pregnancy tests must be negative",
                        "criterion": "pregnancy test result",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "must be non-lactating",
                        "criterion": "lactation status",
                        "requirement": {
                            "requirement_type": "lactating",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "adequate barrier contraceptive measures were taken at the end of treatment and 6 months after the end of treatment",
                        "criterion": "contraceptive measures",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": [
                                "at the end of treatment",
                                "6 months after the end of treatment"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "adequate barrier contraceptive measures were taken at the end of treatment and 6 months after the end of treatment",
                        "criterion": "contraceptive measures",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "condition": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "premenopausal women who are likely to have children",
                                    "criterion": "premenopausal status",
                                    "requirement": {
                                        "requirement_type": "likelihood of having children",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "exact_snippets": "pregnancy test should be performed within 7 days of starting treatment",
                                    "criterion": "pregnancy test timing",
                                    "requirement": {
                                        "requirement_type": "timing",
                                        "expected_value": "within 7 days of starting treatment"
                                    }
                                }
                            ]
                        },
                        "then_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "clear or urine pregnancy tests must be negative",
                                    "criterion": "pregnancy test result",
                                    "requirement": {
                                        "requirement_type": "result",
                                        "expected_value": "negative"
                                    }
                                },
                                {
                                    "exact_snippets": "must be non-lactating",
                                    "criterion": "lactation status",
                                    "requirement": {
                                        "requirement_type": "lactating",
                                        "expected_value": false
                                    }
                                }
                            ]
                        },
                        "else_criteria": null
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "adequate barrier contraceptive measures were taken at the end of treatment and 6 months after the end of treatment",
                                "criterion": "contraceptive measures",
                                "requirement": {
                                    "requirement_type": "timing",
                                    "expected_value": [
                                        "at the end of treatment",
                                        "6 months after the end of treatment"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "adequate barrier contraceptive measures were taken at the end of treatment and 6 months after the end of treatment",
                                "criterion": "contraceptive measures",
                                "requirement": {
                                    "requirement_type": "adequacy",
                                    "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 be FEMALE",
                "criterions": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "female"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "female"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 75 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 75 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 75 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "1. ADC drugs that have received topoisomerase I inhibitors (camptothecins) as small molecule toxins.",
                "criterions": [
                    {
                        "exact_snippets": "ADC drugs that have received topoisomerase I inhibitors (camptothecins) as small molecule toxins",
                        "criterion": "ADC drugs",
                        "requirement": {
                            "requirement_type": "received",
                            "expected_value": "topoisomerase I inhibitors (camptothecins) as small molecule toxins"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "ADC drugs that have received topoisomerase I inhibitors (camptothecins) as small molecule toxins",
                    "criterion": "ADC drugs",
                    "requirement": {
                        "requirement_type": "received",
                        "expected_value": "topoisomerase I inhibitors (camptothecins) as small molecule toxins"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "2. Administration of chemotherapy or chemotherapy within 4 weeks or 5 half-lives, whichever is shorter, before the first dose physical therapy, immunotherapy, definitive radiotherapy, major surgery (investigator's definition), targeted therapy (including minor) molecular tyrosine kinase inhibitors) and other anti-tumor therapy; Oral fluorouracil drugs such as S-1, carboplatin ecitabine or palliative radiotherapy within 2 weeks before the first dose.",
                "criterions": [
                    {
                        "exact_snippets": "Administration of chemotherapy or chemotherapy within 4 weeks or 5 half-lives, whichever is shorter, before the first dose",
                        "criterion": "chemotherapy administration",
                        "requirement": {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "physical therapy, immunotherapy, definitive radiotherapy, major surgery (investigator's definition), targeted therapy (including minor) molecular tyrosine kinase inhibitors) and other anti-tumor therapy",
                        "criterion": "other anti-tumor therapies",
                        "requirement": {
                            "requirement_type": "administration",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Oral fluorouracil drugs such as S-1, carboplatin ecitabine or palliative radiotherapy within 2 weeks before the first dose",
                        "criterion": "oral fluorouracil drugs or palliative radiotherapy",
                        "requirement": {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Administration of chemotherapy or chemotherapy within 4 weeks or 5 half-lives, whichever is shorter, before the first dose",
                                "criterion": "chemotherapy administration",
                                "requirement": {
                                    "requirement_type": "time since last administration",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "<=",
                                                "value": 4,
                                                "unit": "weeks"
                                            }
                                        ]
                                    }
                                }
                            },
                            {
                                "exact_snippets": "physical therapy, immunotherapy, definitive radiotherapy, major surgery (investigator's definition), targeted therapy (including minor) molecular tyrosine kinase inhibitors) and other anti-tumor therapy",
                                "criterion": "other anti-tumor therapies",
                                "requirement": {
                                    "requirement_type": "administration",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Oral fluorouracil drugs such as S-1, carboplatin ecitabine or palliative radiotherapy within 2 weeks before the first dose",
                        "criterion": "oral fluorouracil drugs or palliative radiotherapy",
                        "requirement": {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Use of immunomodulatory drugs within 14 days before the first use of the study drug: including but not limited to thymosin, interleukin-2, interferon, etc.",
                "criterions": [
                    {
                        "exact_snippets": "Use of immunomodulatory drugs within 14 days before the first use of the study drug",
                        "criterion": "use of immunomodulatory drugs",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Use of immunomodulatory drugs within 14 days before the first use of the study drug",
                        "criterion": "use of immunomodulatory drugs",
                        "requirement": {
                            "requirement_type": "proximity to study drug",
                            "expected_value": "before first use"
                        }
                    },
                    {
                        "exact_snippets": "including but not limited to thymosin, interleukin-2, interferon, etc.",
                        "criterion": "specific immunomodulatory drugs",
                        "requirement": {
                            "requirement_type": "examples",
                            "expected_value": [
                                "thymosin",
                                "interleukin-2",
                                "interferon"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Use of immunomodulatory drugs within 14 days before the first use of the study drug",
                                "criterion": "use of immunomodulatory drugs",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 14,
                                        "unit": "days"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Use of immunomodulatory drugs within 14 days before the first use of the study drug",
                                "criterion": "use of immunomodulatory drugs",
                                "requirement": {
                                    "requirement_type": "proximity to study drug",
                                    "expected_value": "before first use"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "including but not limited to thymosin, interleukin-2, interferon, etc.",
                        "criterion": "specific immunomodulatory drugs",
                        "requirement": {
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                            "expected_value": [
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                                "interleukin-2",
                                "interferon"
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                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Systemic corticosteroids (> 10mg/ day prednisone, or other corticosteroids in equivalent amounts); Inhaled or topical administration of hormones, or received physiology for adrenal insufficiency alternative doses of hormone therapy were excluded.",
                "criterions": [
                    {
                        "exact_snippets": "Systemic corticosteroids (> 10mg/ day prednisone, or other corticosteroids in equivalent amounts)",
                        "criterion": "systemic corticosteroids",
                        "requirement": {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg/day prednisone equivalent"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Inhaled or topical administration of hormones",
                        "criterion": "inhaled or topical hormone administration",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "received physiology for adrenal insufficiency alternative doses of hormone therapy",
                        "criterion": "physiology for adrenal insufficiency alternative doses of hormone therapy",
                        "requirement": {
                            "requirement_type": "receipt",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Systemic corticosteroids (> 10mg/ day prednisone, or other corticosteroids in equivalent amounts)",
                                "criterion": "systemic corticosteroids",
                                "requirement": {
                                    "requirement_type": "dosage",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 10,
                                        "unit": "mg/day prednisone equivalent"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Inhaled or topical administration of hormones",
                                "criterion": "inhaled or topical hormone administration",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "received physiology for adrenal insufficiency alternative doses of hormone therapy",
                                "criterion": "physiology for adrenal insufficiency alternative doses of hormone therapy",
                                "requirement": {
                                    "requirement_type": "receipt",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Patients with grade ≥3 irAE or grade ≥2 immune-related myocarditis who had received immunotherapy were excluded.",
                "criterions": [
                    {
                        "exact_snippets": "grade ≥3 irAE",
                        "criterion": "irAE",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "grade ≥2 immune-related myocarditis",
                        "criterion": "immune-related myocarditis",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "had received immunotherapy",
                        "criterion": "immunotherapy",
                        "requirement": {
                            "requirement_type": "treatment history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "grade ≥3 irAE",
                                        "criterion": "irAE",
                                        "requirement": {
                                            "requirement_type": "grade",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 3,
                                                "unit": "N/A"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "had received immunotherapy",
                                        "criterion": "immunotherapy",
                                        "requirement": {
                                            "requirement_type": "treatment history",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "grade ≥2 immune-related myocarditis",
                                        "criterion": "immune-related myocarditis",
                                        "requirement": {
                                            "requirement_type": "grade",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 2,
                                                "unit": "N/A"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "had received immunotherapy",
                                        "criterion": "immunotherapy",
                                        "requirement": {
                                            "requirement_type": "treatment history",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. A history of severe cardiovascular and cerebrovascular diseases, including but not limited to:",
                "criterions": [
                    {
                        "exact_snippets": "A history of severe cardiovascular ... diseases",
                        "criterion": "cardiovascular diseases",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "A history of severe cardiovascular ... diseases",
                        "criterion": "cardiovascular diseases",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "A history of severe ... cerebrovascular diseases",
                        "criterion": "cerebrovascular diseases",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "A history of severe ... cerebrovascular diseases",
                        "criterion": "cerebrovascular diseases",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "A history of severe cardiovascular ... diseases",
                                "criterion": "cardiovascular diseases",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "severe"
                                }
                            },
                            {
                                "exact_snippets": "A history of severe cardiovascular ... diseases",
                                "criterion": "cardiovascular diseases",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "A history of severe ... cerebrovascular diseases",
                                "criterion": "cerebrovascular diseases",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "severe"
                                }
                            },
                            {
                                "exact_snippets": "A history of severe ... cerebrovascular diseases",
                                "criterion": "cerebrovascular diseases",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias or grade III atria requiring clinical intervention Ventricular block;",
                "criterions": [
                    {
                        "exact_snippets": "severe cardiac rhythm or conduction abnormalities",
                        "criterion": "cardiac rhythm or conduction abnormalities",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "ventricular arrhythmias",
                        "criterion": "ventricular arrhythmias",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "grade III atria requiring clinical intervention",
                        "criterion": "grade III atria",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "grade III"
                        }
                    },
                    {
                        "exact_snippets": "grade III atria requiring clinical intervention",
                        "criterion": "grade III atria",
                        "requirement": {
                            "requirement_type": "intervention",
                            "expected_value": "clinical intervention"
                        }
                    },
                    {
                        "exact_snippets": "Ventricular block",
                        "criterion": "ventricular block",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "severe cardiac rhythm or conduction abnormalities",
                                "criterion": "cardiac rhythm or conduction abnormalities",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "severe"
                                }
                            },
                            {
                                "exact_snippets": "ventricular arrhythmias",
                                "criterion": "ventricular arrhythmias",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "grade III atria requiring clinical intervention",
                                "criterion": "grade III atria",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "grade III"
                                }
                            },
                            {
                                "exact_snippets": "grade III atria requiring clinical intervention",
                                "criterion": "grade III atria",
                                "requirement": {
                                    "requirement_type": "intervention",
                                    "expected_value": "clinical intervention"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Ventricular block",
                        "criterion": "ventricular block",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. prolonged QT interval at rest (QTc > 450 msec in men or QTc > 470 msec in women);",
                "criterions": [
                    {
                        "exact_snippets": "prolonged QT interval at rest (QTc > 450 msec in men",
                        "criterion": "QT interval at rest",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 450,
                                "unit": "msec"
                            }
                        }
                    },
                    {
                        "exact_snippets": "prolonged QT interval at rest ... QTc > 470 msec in women",
                        "criterion": "QT interval at rest",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 470,
                                "unit": "msec"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "prolonged QT interval at rest (QTc > 450 msec in men",
                                "criterion": "QT interval at rest",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 450,
                                        "unit": "msec"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "prolonged QT interval at rest (QTc > 450 msec in men",
                                "criterion": "gender",
                                "requirement": {
                                    "requirement_type": "identity",
                                    "expected_value": "male"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "prolonged QT interval at rest ... QTc > 470 msec in women",
                                "criterion": "QT interval at rest",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 470,
                                        "unit": "msec"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "prolonged QT interval at rest ... QTc > 470 msec in women",
                                "criterion": "gender",
                                "requirement": {
                                    "requirement_type": "identity",
                                    "expected_value": "female"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. myocardial infarction, unstable angina, cardiac angioplasty, or within 6 months before the first dose Stent implantation, coronary artery/peripheral artery bypass grafting, New York Heart Association Defined class III or IV congestive heart failure, cerebrovascular accident, or transient ischemic attack.",
                "criterions": [
                    {
                        "exact_snippets": "myocardial infarction",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "unstable angina",
                        "criterion": "unstable angina",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "cardiac angioplasty",
                        "criterion": "cardiac angioplasty",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Stent implantation",
                        "criterion": "Stent implantation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "coronary artery/peripheral artery bypass grafting",
                        "criterion": "coronary artery bypass grafting",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "coronary artery/peripheral artery bypass grafting",
                        "criterion": "peripheral artery bypass grafting",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "New York Heart Association Defined class III or IV congestive heart failure",
                        "criterion": "New York Heart Association Defined class III or IV congestive heart failure",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "cerebrovascular accident",
                        "criterion": "cerebrovascular accident",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "transient ischemic attack",
                        "criterion": "transient ischemic attack",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "myocardial infarction",
                                "criterion": "myocardial infarction",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "within 6 months before the first dose",
                                "criterion": "time since event",
                                "requirement": {
                                    "requirement_type": "time since event",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "unstable angina",
                                "criterion": "unstable angina",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "within 6 months before the first dose",
                                "criterion": "time since event",
                                "requirement": {
                                    "requirement_type": "time since event",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "cardiac angioplasty",
                                "criterion": "cardiac angioplasty",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "within 6 months before the first dose",
                                "criterion": "time since event",
                                "requirement": {
                                    "requirement_type": "time since event",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Stent implantation",
                                "criterion": "Stent implantation",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "within 6 months before the first dose",
                                "criterion": "time since event",
                                "requirement": {
                                    "requirement_type": "time since event",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "coronary artery/peripheral artery bypass grafting",
                                "criterion": "coronary artery bypass grafting",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "within 6 months before the first dose",
                                "criterion": "time since event",
                                "requirement": {
                                    "requirement_type": "time since event",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "coronary artery/peripheral artery bypass grafting",
                                "criterion": "peripheral artery bypass grafting",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "within 6 months before the first dose",
                                "criterion": "time since event",
                                "requirement": {
                                    "requirement_type": "time since event",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "New York Heart Association Defined class III or IV congestive heart failure",
                        "criterion": "New York Heart Association Defined class III or IV congestive heart failure",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "cerebrovascular accident",
                        "criterion": "cerebrovascular accident",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "transient ischemic attack",
                        "criterion": "transient ischemic attack",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, silver requiring systemic treatment dandruptitis, rheumatoid arthritis, inflammatory bowel disease and hashimoto's thyroiditis, except type I diabetes, hypothyroidism that can be controlled only by replacement therapy, skin diseases that do not require systemic treatment (e.g., vitiligo, silver) Dandruff).",
                "criterions": [
                    {
                        "exact_snippets": "Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, ... rheumatoid arthritis, inflammatory bowel disease and hashimoto's thyroiditis",
                        "criterion": "active autoimmune diseases and inflammatory diseases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "type I diabetes",
                        "criterion": "type I diabetes",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "hypothyroidism that can be controlled only by replacement therapy",
                        "criterion": "hypothyroidism",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "only by replacement therapy"
                        }
                    },
                    {
                        "exact_snippets": "skin diseases that do not require systemic treatment (e.g., vitiligo, silver)",
                        "criterion": "skin diseases",
                        "requirement": {
                            "requirement_type": "treatment requirement",
                            "expected_value": "do not require systemic treatment"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, ... rheumatoid arthritis, inflammatory bowel disease and hashimoto's thyroiditis",
                            "criterion": "active autoimmune diseases and inflammatory diseases",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "type I diabetes",
                                    "criterion": "type I diabetes",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "exact_snippets": "hypothyroidism that can be controlled only by replacement therapy",
                                    "criterion": "hypothyroidism",
                                    "requirement": {
                                        "requirement_type": "control",
                                        "expected_value": "only by replacement therapy"
                                    }
                                },
                                {
                                    "exact_snippets": "skin diseases that do not require systemic treatment (e.g., vitiligo, silver)",
                                    "criterion": "skin diseases",
                                    "requirement": {
                                        "requirement_type": "treatment requirement",
                                        "expected_value": "do not require systemic treatment"
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Other malignancies that progressed or required treatment within 3 years before the first dose, such as the following external: radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or radical carcinoma in situ.",
                "criterions": [
                    {
                        "exact_snippets": "Other malignancies that progressed or required treatment within 3 years before the first dose",
                        "criterion": "other malignancies",
                        "requirement": {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Other malignancies that progressed or required treatment within 3 years before the first dose",
                        "criterion": "other malignancies",
                        "requirement": {
                            "requirement_type": "treatment requirement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Other malignancies that progressed or required treatment within 3 years before the first dose",
                        "criterion": "other malignancies",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "radical basal cell carcinoma of the skin",
                        "criterion": "radical basal cell carcinoma of the skin",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "squamous cell carcinoma of the skin",
                        "criterion": "squamous cell carcinoma of the skin",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "radical carcinoma in situ",
                        "criterion": "radical carcinoma in situ",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "or_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "and_criteria": [
                                                    {
                                                        "exact_snippets": "Other malignancies that progressed or required treatment within 3 years before the first dose",
                                                        "criterion": "other malignancies",
                                                        "requirement": {
                                                            "requirement_type": "progression",
                                                            "expected_value": true
                                                        }
                                                    },
                                                    {
                                                        "exact_snippets": "Other malignancies that progressed or required treatment within 3 years before the first dose",
                                                        "criterion": "other malignancies",
                                                        "requirement": {
                                                            "requirement_type": "time frame",
                                                            "expected_value": {
                                                                "operator": "<=",
                                                                "value": 3,
                                                                "unit": "years"
                                                            }
                                                        }
                                                    }
                                                ]
                                            },
                                            {
                                                "and_criteria": [
                                                    {
                                                        "exact_snippets": "Other malignancies that progressed or required treatment within 3 years before the first dose",
                                                        "criterion": "other malignancies",
                                                        "requirement": {
                                                            "requirement_type": "treatment requirement",
                                                            "expected_value": true
                                                        }
                                                    },
                                                    {
                                                        "exact_snippets": "Other malignancies that progressed or required treatment within 3 years before the first dose",
                                                        "criterion": "other malignancies",
                                                        "requirement": {
                                                            "requirement_type": "time frame",
                                                            "expected_value": {
                                                                "operator": "<=",
                                                                "value": 3,
                                                                "unit": "years"
                                                            }
                                                        }
                                                    }
                                                ]
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "radical basal cell carcinoma of the skin",
                                        "criterion": "radical basal cell carcinoma of the skin",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "squamous cell carcinoma of the skin",
                                        "criterion": "squamous cell carcinoma of the skin",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "radical carcinoma in situ",
                                        "criterion": "radical carcinoma in situ",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. History or current history of (noninfectious) interstitial lung disease (ILD)/pulmonary inflammation requiring steroid therapy patients with ILD/ pulmonary inflammation, or suspected ILD/ pulmonary inflammation that cannot be excluded by imaging at the time of screening.",
                "criterions": [
                    {
                        "exact_snippets": "History or current history of (noninfectious) interstitial lung disease (ILD)/pulmonary inflammation",
                        "criterion": "interstitial lung disease (ILD)/pulmonary inflammation",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "requiring steroid therapy",
                        "criterion": "steroid therapy",
                        "requirement": {
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "patients with ILD/ pulmonary inflammation, or suspected ILD/ pulmonary inflammation that cannot be excluded by imaging at the time of screening",
                        "criterion": "ILD/ pulmonary inflammation",
                        "requirement": {
                            "requirement_type": "exclusion by imaging",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History or current history of (noninfectious) interstitial lung disease (ILD)/pulmonary inflammation",
                                "criterion": "interstitial lung disease (ILD)/pulmonary inflammation",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "requiring steroid therapy",
                                "criterion": "steroid therapy",
                                "requirement": {
                                    "requirement_type": "requirement",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "patients with ILD/ pulmonary inflammation, or suspected ILD/ pulmonary inflammation that cannot be excluded by imaging at the time of screening",
                        "criterion": "ILD/ pulmonary inflammation",
                        "requirement": {
                            "requirement_type": "exclusion by imaging",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. Poorly controlled diabetes (fasting blood glucose ≥ 13.3 mmol/L)",
                "criterions": [
                    {
                        "exact_snippets": "Poorly controlled diabetes",
                        "criterion": "diabetes",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    },
                    {
                        "exact_snippets": "fasting blood glucose ≥ 13.3 mmol/L",
                        "criterion": "fasting blood glucose",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 13.3,
                                "unit": "mmol/L"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Poorly controlled diabetes",
                        "criterion": "diabetes",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    },
                    {
                        "exact_snippets": "fasting blood glucose ≥ 13.3 mmol/L",
                        "criterion": "fasting blood glucose",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 13.3,
                                "unit": "mmol/L"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Poorly controlled hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg)",
                "criterions": [
                    {
                        "exact_snippets": "Poorly controlled hypertension (systolic blood pressure ≥ 140 mmHg ...",
                        "criterion": "systolic blood pressure",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">=",
                                "value": 140,
                                "unit": "mmHg"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Poorly controlled hypertension ... diastolic blood pressure ≥ 90 mmHg",
                        "criterion": "diastolic blood pressure",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "mmHg"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Poorly controlled hypertension (systolic blood pressure ≥ 140 mmHg ...",
                                "criterion": "systolic blood pressure",
                                "requirement": {
                                    "requirement_type": "comparison",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 140,
                                        "unit": "mmHg"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Poorly controlled hypertension ... diastolic blood pressure ≥ 90 mmHg",
                                "criterion": "diastolic blood pressure",
                                "requirement": {
                                    "requirement_type": "comparison",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 90,
                                        "unit": "mmHg"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. History of hypertensive crisis or hypertensive encephalopathy.",
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                    {
                        "exact_snippets": "History of hypertensive crisis",
                        "criterion": "hypertensive crisis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of ... hypertensive encephalopathy",
                        "criterion": "hypertensive encephalopathy",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "History of hypertensive crisis",
                        "criterion": "hypertensive crisis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of ... hypertensive encephalopathy",
                        "criterion": "hypertensive encephalopathy",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "11. Unstable deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring medical intervention within 6 months before screening thrombotic events such as plug; Infusion-related thrombosis was excluded.",
                "criterions": [
                    {
                        "exact_snippets": "Unstable deep vein thrombosis",
                        "criterion": "deep vein thrombosis",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    },
                    {
                        "exact_snippets": "arterial thrombosis",
                        "criterion": "arterial thrombosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "pulmonary embolism requiring medical intervention within 6 months before screening",
                        "criterion": "pulmonary embolism",
                        "requirement": {
                            "requirement_type": "medical intervention",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "pulmonary embolism requiring medical intervention within 6 months before screening",
                        "criterion": "pulmonary embolism",
                        "requirement": {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "thrombotic events such as plug",
                        "criterion": "thrombotic events",
                        "requirement": {
                            "requirement_type": "examples",
                            "expected_value": [
                                "plug"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Infusion-related thrombosis was excluded",
                        "criterion": "infusion-related thrombosis",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Unstable deep vein thrombosis",
                                "criterion": "deep vein thrombosis",
                                "requirement": {
                                    "requirement_type": "stability",
                                    "expected_value": "unstable"
                                }
                            },
                            {
                                "exact_snippets": "arterial thrombosis",
                                "criterion": "arterial thrombosis",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "pulmonary embolism requiring medical intervention within 6 months before screening",
                                        "criterion": "pulmonary embolism",
                                        "requirement": {
                                            "requirement_type": "medical intervention",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "pulmonary embolism requiring medical intervention within 6 months before screening",
                                        "criterion": "pulmonary embolism",
                                        "requirement": {
                                            "requirement_type": "timeframe",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 6,
                                                "unit": "months"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "thrombotic events such as plug",
                        "criterion": "thrombotic events",
                        "requirement": {
                            "requirement_type": "examples",
                            "expected_value": [
                                "plug"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Infusion-related thrombosis was excluded",
                        "criterion": "infusion-related thrombosis",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "12. Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis (meningeal metastases). Patients who had received treatment for brain metastases (radiotherapy or surgery; Patients with stable brain metastases who had stopped radiotherapy or surgery 28 days before the first dose were eligible. Patients with cancerous meningitis (meningeal metastasis) were excluded even if they were treated and judged to be stable. Stability is defined as meeting the following four criteria:",
                "criterions": [
                    {
                        "exact_snippets": "central nervous system (CNS) metastases",
                        "criterion": "central nervous system metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "carcinomatous meningitis (meningeal metastases)",
                        "criterion": "carcinomatous meningitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "treatment for brain metastases (radiotherapy or surgery",
                        "criterion": "treatment for brain metastases",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "radiotherapy",
                                "surgery"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "stable brain metastases",
                        "criterion": "stable brain metastases",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "stopped radiotherapy or surgery 28 days before the first dose",
                        "criterion": "time since treatment cessation",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "cancerous meningitis (meningeal metastasis)",
                        "criterion": "cancerous meningitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "treated and judged to be stable",
                        "criterion": "stability after treatment",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "central nervous system (CNS) metastases",
                                "criterion": "central nervous system metastases",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "carcinomatous meningitis (meningeal metastases)",
                                        "criterion": "carcinomatous meningitis",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "treatment for brain metastases (radiotherapy or surgery",
                                                "criterion": "treatment for brain metastases",
                                                "requirement": {
                                                    "requirement_type": "treatment",
                                                    "expected_value": [
                                                        "radiotherapy",
                                                        "surgery"
                                                    ]
                                                }
                                            },
                                            {
                                                "exact_snippets": "stable brain metastases",
                                                "criterion": "stable brain metastases",
                                                "requirement": {
                                                    "requirement_type": "stability",
                                                    "expected_value": true
                                                }
                                            },
                                            {
                                                "exact_snippets": "stopped radiotherapy or surgery 28 days before the first dose",
                                                "criterion": "time since treatment cessation",
                                                "requirement": {
                                                    "requirement_type": "duration",
                                                    "expected_value": {
                                                        "operator": ">=",
                                                        "value": 28,
                                                        "unit": "days"
                                                    }
                                                }
                                            }
                                        ]
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "cancerous meningitis (meningeal metastasis)",
                        "criterion": "cancerous meningitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "treated and judged to be stable",
                        "criterion": "stability after treatment",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. seizure-free status for > 12 weeks with or without antiepileptic medication;",
                "criterions": [
                    {
                        "exact_snippets": "seizure-free status for > 12 weeks",
                        "criterion": "seizure-free status",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "with or without antiepileptic medication",
                        "criterion": "antiepileptic medication",
                        "requirement": {
                            "requirement_type": "usage",
                            "expected_value": [
                                "with",
                                "without"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "seizure-free status for > 12 weeks",
                        "criterion": "seizure-free status",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "with or without antiepileptic medication",
                        "criterion": "antiepileptic medication",
                        "requirement": {
                            "requirement_type": "usage",
                            "expected_value": [
                                "with",
                                "without"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. no need for corticosteroids;",
                "criterions": [
                    {
                        "exact_snippets": "no need for corticosteroids",
                        "criterion": "corticosteroid use",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "no need for corticosteroids",
                    "criterion": "corticosteroid use",
                    "requirement": {
                        "requirement_type": "necessity",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "3. stable on two consecutive MRI scans (at least 4 weeks apart);",
                "criterions": [
                    {
                        "exact_snippets": "stable on two consecutive MRI scans (at least 4 weeks apart)",
                        "criterion": "MRI scan stability",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "stable on two consecutive MRI scans (at least 4 weeks apart)",
                        "criterion": "MRI scan stability",
                        "requirement": {
                            "requirement_type": "time interval",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "stable on two consecutive MRI scans (at least 4 weeks apart)",
                        "criterion": "MRI scan stability",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "stable on two consecutive MRI scans (at least 4 weeks apart)",
                        "criterion": "MRI scan stability",
                        "requirement": {
                            "requirement_type": "time interval",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. stable and asymptomatic for more than one month after treatment.",
                "criterions": [
                    {
                        "exact_snippets": "stable and asymptomatic",
                        "criterion": "patient condition",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "stable and asymptomatic",
                        "criterion": "patient condition",
                        "requirement": {
                            "requirement_type": "symptoms",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "more than one month after treatment",
                        "criterion": "time since treatment",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "stable and asymptomatic",
                                "criterion": "patient condition",
                                "requirement": {
                                    "requirement_type": "stability",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "stable and asymptomatic",
                                "criterion": "patient condition",
                                "requirement": {
                                    "requirement_type": "symptoms",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "more than one month after treatment",
                        "criterion": "time since treatment",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "13. Patients with pleural effusion, pericardial effusion or ascites with clinical symptoms or requiring repeated drainage.",
                "criterions": [
                    {
                        "exact_snippets": "pleural effusion",
                        "criterion": "pleural effusion",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "pleural effusion",
                        "criterion": "pleural effusion",
                        "requirement": {
                            "requirement_type": "symptoms",
                            "expected_value": "clinical symptoms"
                        }
                    },
                    {
                        "exact_snippets": "pleural effusion",
                        "criterion": "pleural effusion",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "requiring repeated drainage"
                        }
                    },
                    {
                        "exact_snippets": "pericardial effusion",
                        "criterion": "pericardial effusion",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "pericardial effusion",
                        "criterion": "pericardial effusion",
                        "requirement": {
                            "requirement_type": "symptoms",
                            "expected_value": "clinical symptoms"
                        }
                    },
                    {
                        "exact_snippets": "pericardial effusion",
                        "criterion": "pericardial effusion",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "requiring repeated drainage"
                        }
                    },
                    {
                        "exact_snippets": "ascites",
                        "criterion": "ascites",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "ascites",
                        "criterion": "ascites",
                        "requirement": {
                            "requirement_type": "symptoms",
                            "expected_value": "clinical symptoms"
                        }
                    },
                    {
                        "exact_snippets": "ascites",
                        "criterion": "ascites",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "requiring repeated drainage"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "pleural effusion",
                                "criterion": "pleural effusion",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "pleural effusion",
                                        "criterion": "pleural effusion",
                                        "requirement": {
                                            "requirement_type": "symptoms",
                                            "expected_value": "clinical symptoms"
                                        }
                                    },
                                    {
                                        "exact_snippets": "pleural effusion",
                                        "criterion": "pleural effusion",
                                        "requirement": {
                                            "requirement_type": "treatment",
                                            "expected_value": "requiring repeated drainage"
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "pericardial effusion",
                                "criterion": "pericardial effusion",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "pericardial effusion",
                                        "criterion": "pericardial effusion",
                                        "requirement": {
                                            "requirement_type": "symptoms",
                                            "expected_value": "clinical symptoms"
                                        }
                                    },
                                    {
                                        "exact_snippets": "pericardial effusion",
                                        "criterion": "pericardial effusion",
                                        "requirement": {
                                            "requirement_type": "treatment",
                                            "expected_value": "requiring repeated drainage"
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "ascites",
                                "criterion": "ascites",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "ascites",
                                        "criterion": "ascites",
                                        "requirement": {
                                            "requirement_type": "symptoms",
                                            "expected_value": "clinical symptoms"
                                        }
                                    },
                                    {
                                        "exact_snippets": "ascites",
                                        "criterion": "ascites",
                                        "requirement": {
                                            "requirement_type": "treatment",
                                            "expected_value": "requiring repeated drainage"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "14. Allergic history to recombinant humanized antibody or human-mouse chimeric antibody or any excipients of BL-B01D1 sensitive patients.",
                "criterions": [
                    {
                        "exact_snippets": "Allergic history to recombinant humanized antibody",
                        "criterion": "allergic history to recombinant humanized antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Allergic history to ... human-mouse chimeric antibody",
                        "criterion": "allergic history to human-mouse chimeric antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Allergic history to ... any excipients of BL-B01D1",
                        "criterion": "allergic history to excipients of BL-B01D1",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Allergic history to recombinant humanized antibody",
                        "criterion": "allergic history to recombinant humanized antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Allergic history to ... human-mouse chimeric antibody",
                        "criterion": "allergic history to human-mouse chimeric antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Allergic history to ... any excipients of BL-B01D1",
                        "criterion": "allergic history to excipients of BL-B01D1",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "15. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT).",
                "criterions": [
                    {
                        "exact_snippets": "Prior organ transplantation",
                        "criterion": "organ transplantation",
                        "requirement": {
                            "requirement_type": "prior occurrence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "allogeneic hematopoietic stem cell transplantation (Allo-HSCT)",
                        "criterion": "allogeneic hematopoietic stem cell transplantation",
                        "requirement": {
                            "requirement_type": "prior occurrence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Prior organ transplantation",
                        "criterion": "organ transplantation",
                        "requirement": {
                            "requirement_type": "prior occurrence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "allogeneic hematopoietic stem cell transplantation (Allo-HSCT)",
                        "criterion": "allogeneic hematopoietic stem cell transplantation",
                        "requirement": {
                            "requirement_type": "prior occurrence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "16. Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, or active hepatitis C virus infection (HCV antibody positive and HCV-RNA > lower detection limit).",
                "criterions": [
                    {
                        "exact_snippets": "Human immunodeficiency virus antibody (HIVAb) positive",
                        "criterion": "HIV antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "active tuberculosis",
                        "criterion": "tuberculosis",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "active hepatitis C virus infection (HCV antibody positive and HCV-RNA > lower detection limit)",
                        "criterion": "hepatitis C virus infection",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "HCV antibody positive",
                        "criterion": "HCV antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "HCV-RNA > lower detection limit",
                        "criterion": "HCV-RNA",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 0,
                                "unit": "lower detection limit"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Human immunodeficiency virus antibody (HIVAb) positive",
                        "criterion": "HIV antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "active tuberculosis",
                        "criterion": "tuberculosis",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "active hepatitis C virus infection (HCV antibody positive and HCV-RNA > lower detection limit)",
                                "criterion": "hepatitis C virus infection",
                                "requirement": {
                                    "requirement_type": "activity",
                                    "expected_value": "active"
                                }
                            },
                            {
                                "exact_snippets": "HCV antibody positive",
                                "criterion": "HCV antibody",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "HCV-RNA > lower detection limit",
                                "criterion": "HCV-RNA",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 0,
                                        "unit": "lower detection limit"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "18. Active infection requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.",
                "criterions": [
                    {
                        "exact_snippets": "Active infection requiring systemic treatment",
                        "criterion": "active infection",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "systemic"
                        }
                    },
                    {
                        "exact_snippets": "severe pneumonia",
                        "criterion": "severe pneumonia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "bacteremia",
                        "criterion": "bacteremia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "sepsis",
                        "criterion": "sepsis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Active infection requiring systemic treatment",
                                "criterion": "active infection",
                                "requirement": {
                                    "requirement_type": "treatment",
                                    "expected_value": "systemic"
                                }
                            },
                            {
                                "exact_snippets": "severe pneumonia",
                                "criterion": "severe pneumonia",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "bacteremia",
                        "criterion": "bacteremia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "sepsis",
                        "criterion": "sepsis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "19. Had participated in another clinical trial within 4 weeks before the first dose (calculated from the time of last dose).",
                "criterions": [
                    {
                        "exact_snippets": "Had participated in another clinical trial within 4 weeks before the first dose",
                        "criterion": "participation in another clinical trial",
                        "requirement": {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Had participated in another clinical trial within 4 weeks before the first dose",
                    "criterion": "participation in another clinical trial",
                    "requirement": {
                        "requirement_type": "time since last dose",
                        "expected_value": {
                            "operator": ">=",
                            "value": 4,
                            "unit": "weeks"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "20. Persons with a history of psychotropic drug abuse and inability to quit or mental disorders.",
                "criterions": [
                    {
                        "exact_snippets": "history of psychotropic drug abuse",
                        "criterion": "psychotropic drug abuse",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "inability to quit",
                        "criterion": "ability to quit psychotropic drugs",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "mental disorders",
                        "criterion": "mental disorders",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "history of psychotropic drug abuse",
                                "criterion": "psychotropic drug abuse",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "inability to quit",
                                "criterion": "ability to quit psychotropic drugs",
                                "requirement": {
                                    "requirement_type": "ability",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "mental disorders",
                        "criterion": "mental disorders",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "21. Any other circumstances that the investigator deemed inappropriate for participation in the trial.",
                "criterions": [
                    {
                        "exact_snippets": "Any other circumstances that the investigator deemed inappropriate for participation",
                        "criterion": "circumstances deemed inappropriate by investigator",
                        "requirement": {
                            "requirement_type": "appropriateness",
                            "expected_value": "deemed inappropriate by investigator"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Any other circumstances that the investigator deemed inappropriate for participation",
                    "criterion": "circumstances deemed inappropriate by investigator",
                    "requirement": {
                        "requirement_type": "appropriateness",
                        "expected_value": "deemed inappropriate by investigator"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "10. Prior to starting the study treatment, there are:",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "4. ECOG 0 or 1.",
                "criterions": [
                    {
                        "exact_snippets": "ECOG 0 or 1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "ECOG 0 or 1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "0"
                        }
                    },
                    {
                        "exact_snippets": "ECOG 0 or 1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "1"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Pathologically and/or cytologically confirmed patients who have failed standard treatment, or have no access to standard treatment Patients with unresectable, locally advanced or recurrent, metastatic HER2-negative breast cancer after posterior line.",
                "criterions": [
                    {
                        "exact_snippets": "Pathologically and/or cytologically confirmed",
                        "criterion": "confirmation method",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": [
                                "pathologically",
                                "cytologically"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "failed standard treatment, or have no access to standard treatment",
                        "criterion": "standard treatment status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "failed",
                                "no access"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "unresectable, locally advanced or recurrent, metastatic HER2-negative breast cancer",
                        "criterion": "breast cancer type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "unresectable",
                                "locally advanced",
                                "recurrent",
                                "metastatic",
                                "HER2-negative"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "failed standard treatment, or have no access to standard treatment",
                                        "criterion": "standard treatment status",
                                        "requirement": {
                                            "requirement_type": "status",
                                            "expected_value": [
                                                "failed"
                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "failed standard treatment, or have no access to standard treatment",
                                        "criterion": "standard treatment status",
                                        "requirement": {
                                            "requirement_type": "status",
                                            "expected_value": [
                                                "no access"
                                            ]
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "Pathologically and/or cytologically confirmed",
                                "criterion": "confirmation method",
                                "requirement": {
                                    "requirement_type": "method",
                                    "expected_value": [
                                        "pathologically",
                                        "cytologically"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "unresectable, locally advanced or recurrent, metastatic HER2-negative breast cancer",
                        "criterion": "breast cancer type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "unresectable",
                                "locally advanced",
                                "recurrent",
                                "metastatic",
                                "HER2-negative"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Agree to provide archived tumor tissue specimens (unstained sections (anti-slip)) from primary or metastatic sites within 2 years. 10 to 12 surgical specimens (4-5 μm thick) or fresh tissue samples if the subject is unable to provide them for 2 years tumor tissue samples from within, can be communicated with the sponsor if other inclusion criteria are met, enrollment was permitted after investigator assessment.",
                "criterions": [
                    {
                        "exact_snippets": "archived tumor tissue specimens (unstained sections (anti-slip)) from primary or metastatic sites within 2 years",
                        "criterion": "archived tumor tissue specimens",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "archived tumor tissue specimens (unstained sections (anti-slip)) from primary or metastatic sites within 2 years",
                        "criterion": "archived tumor tissue specimens",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": [
                                "primary",
                                "metastatic"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "archived tumor tissue specimens (unstained sections (anti-slip)) from primary or metastatic sites within 2 years",
                        "criterion": "archived tumor tissue specimens",
                        "requirement": {
                            "requirement_type": "timeframe",
                            "expected_value": "within 2 years"
                        }
                    },
                    {
                        "exact_snippets": "10 to 12 surgical specimens (4-5 μm thick) or fresh tissue samples",
                        "criterion": "surgical specimens or fresh tissue samples",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 10,
                                        "unit": "specimens"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 12,
                                        "unit": "specimens"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "10 to 12 surgical specimens (4-5 μm thick) or fresh tissue samples",
                        "criterion": "surgical specimens or fresh tissue samples",
                        "requirement": {
                            "requirement_type": "thickness",
                            "expected_value": {
                                "operator": "=",
                                "value": 4,
                                "unit": "μm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "10 to 12 surgical specimens (4-5 μm thick) or fresh tissue samples",
                        "criterion": "surgical specimens or fresh tissue samples",
                        "requirement": {
                            "requirement_type": "thickness",
                            "expected_value": {
                                "operator": "=",
                                "value": 5,
                                "unit": "μm"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "3. Liver function: total bilirubin (TBIL≤1.5 ULN), alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) was ≤2.5 ULN in all patients, and AST and ALT were ≤ in patients with liver metastasis 5.0 ULN;",
                "criterions": [
                    {
                        "exact_snippets": "total bilirubin (TBIL≤1.5 ULN)",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "alanine aminotransferase (ALT) ... ≤2.5 ULN",
                        "criterion": "alanine aminotransferase",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Aspartate aminotransferase (AST) ... ≤2.5 ULN",
                        "criterion": "Aspartate aminotransferase",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "AST and ALT were ≤ in patients with liver metastasis 5.0 ULN",
                        "criterion": "AST and ALT in patients with liver metastasis",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5.0,
                                "unit": "ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "total bilirubin (TBIL≤1.5 ULN)",
                                "criterion": "total bilirubin",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "ULN"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "alanine aminotransferase (ALT) ... ≤2.5 ULN",
                                "criterion": "alanine aminotransferase",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "ULN"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Aspartate aminotransferase (AST) ... ≤2.5 ULN",
                                "criterion": "Aspartate aminotransferase",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "ULN"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "condition": {
                            "exact_snippets": "AST and ALT were ≤ in patients with liver metastasis 5.0 ULN",
                            "criterion": "liver metastasis",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        },
                        "then_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "AST and ALT were ≤ in patients with liver metastasis 5.0 ULN",
                                    "criterion": "AST in patients with liver metastasis",
                                    "requirement": {
                                        "requirement_type": "level",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 5.0,
                                            "unit": "ULN"
                                        }
                                    }
                                },
                                {
                                    "exact_snippets": "AST and ALT were ≤ in patients with liver metastasis 5.0 ULN",
                                    "criterion": "ALT in patients with liver metastasis",
                                    "requirement": {
                                        "requirement_type": "level",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 5.0,
                                            "unit": "ULN"
                                        }
                                    }
                                }
                            ]
                        },
                        "else_criteria": null
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Coagulation function: international normalized ratio (INR) ≤1.5 and activated partial thromboplastin time (APTT) ≤1.5ULN;",
                "criterions": [
                    {
                        "exact_snippets": "Coagulation function: international normalized ratio (INR) ≤1.5",
                        "criterion": "international normalized ratio (INR)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Coagulation function: ... activated partial thromboplastin time (APTT) ≤1.5ULN",
                        "criterion": "activated partial thromboplastin time (APTT)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Coagulation function: international normalized ratio (INR) \u00141.5",
                        "criterion": "international normalized ratio (INR)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Coagulation function: ... activated partial thromboplastin time (APTT) \u00141.5ULN",
                        "criterion": "activated partial thromboplastin time (APTT)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. proteinuria ≤2+ or ≤1000mg/24h.",
                "criterions": [
                    {
                        "exact_snippets": "proteinuria ≤2+",
                        "criterion": "proteinuria",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "+"
                            }
                        }
                    },
                    {
                        "exact_snippets": "proteinuria ... ≤1000mg/24h",
                        "criterion": "proteinuria",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1000,
                                "unit": "mg/24h"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "proteinuria \u00142+",
                        "criterion": "proteinuria",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "+"
                            }
                        }
                    },
                    {
                        "exact_snippets": "proteinuria ... \u00141000mg/24h",
                        "criterion": "proteinuria",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1000,
                                "unit": "mg/24h"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "17. Positive hepatitis B surface antigen (HBsAg) and HBV DNA> 500IU/ml or 2000 copies /ml patients with HBV infection should receive antiviral treatment according to local treatment guidelines and be willing to participate in the study all patients received antiviral therapy during the whole period.",
                "criterions": [
                    {
                        "exact_snippets": "Positive hepatitis B surface antigen (HBsAg)",
                        "criterion": "hepatitis B surface antigen (HBsAg)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "HBV DNA> 500IU/ml or 2000 copies /ml",
                        "criterion": "HBV DNA",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 500,
                                        "unit": "IU/ml"
                                    },
                                    {
                                        "operator": ">",
                                        "value": 2000,
                                        "unit": "copies/ml"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "patients with HBV infection should receive antiviral treatment",
                        "criterion": "antiviral treatment for HBV infection",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "be willing to participate in the study",
                        "criterion": "willingness to participate in the study",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "all patients received antiviral therapy during the whole period",
                        "criterion": "antiviral therapy during the study period",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_miscellaneous": []
}