{
    "info": {
        "nct_id": "NCT06838273",
        "official_title": "A Phase III Randomized Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer",
        "inclusion_criteria": "1. Sign the informed consent form voluntarily and follow the protocol requirements;\n2. Age ≥18 years old;\n3. Expected survival time ≥3 months;\n4. Patients with unresectable or radical radiotherapy for locally advanced non-small cell lung cancer;\n5. Documentation of EGFR sensitive mutations detected from tumor tissue or blood samples;\n6. Consent to provide archived tumor tissue samples or fresh tissue samples of primary or metastatic lesions at or after diagnosis for testing, including EGFR mutation type;\n7. At least one measurable lesion meeting the RECIST v1.1 definition was required;\n8. ECOG 0 or 1;\n9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;\n10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;\n11. The organ function level must meet the requirements on the premise that blood transfusion and colony-stimulating factor are not allowed within 14 days before the screening period;\n12. Urinary protein ≤2+ or < 1000mg/24h;\n13. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, serum pregnancy must be negative, and the patient must not be lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Previous histologic or cytological evidence of small cell or mixed small/non-small cell components;\n2. Patients with previous systemic therapy;\n3. Patients had received EGFR-TKI therapy;\n4. Studies received radical radiotherapy, major surgery, and large area radiotherapy within 4 weeks before randomization;\n5. History of severe heart disease and cerebrovascular disease;\n6. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;\n7. QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;\n8. Were diagnosed with active malignancy within 3 years before randomization;\n9. Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure &gt; 150 mmHg or diastolic blood pressure &gt; 100 mmHg);\n10. Patients with poor glycemic control;\n11. A history of ILD requiring steroid therapy, or current ILD or grade ≥2 radiation pneumonitis, or a suspicion of such disease;\n12. Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;\n13. Patients with active central nervous system metastasis;\n14. Had a severe infection within 4 weeks before randomization;\n15. Patients with massive or symptomatic effusions or poorly controlled effusions;\n16. Imaging examination showed that the tumor had invaded or enveloped the large blood vessels in the abdomen, chest, neck, and pharynx;\n17. Serious unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent;\n18. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;\n19. Patients with a history of inflammatory bowel disease, extensive bowel resection, immune enteritis, intestinal obstruction or chronic diarrhea;\n20. Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of BL-B01D1;\n21. Had autologous or allogeneic stem cell transplantation history;\n22. Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection;\n23. A history of severe neurological or psychiatric illness;\n24. Received other unmarketed investigational drugs or treatments within 4 weeks before randomization;\n25. Subjects scheduled for vaccination or who received live vaccine within 28 days before study randomization;\n26. Other circumstances in which the investigator considered it inappropriate to participate in the trial because of complications or other circumstances.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Sign the informed consent form voluntarily and follow the protocol requirements;",
            "criterions": [
                {
                    "exact_snippets": "Sign the informed consent form voluntarily",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "follow the protocol requirements",
                    "criterion": "protocol adherence",
                    "requirements": [
                        {
                            "requirement_type": "adherence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Age ≥18 years old;",
            "criterions": [
                {
                    "exact_snippets": "Age ≥18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Expected survival time ≥3 months;",
            "criterions": [
                {
                    "exact_snippets": "Expected survival time ≥3 months",
                    "criterion": "expected survival time",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients with unresectable or radical radiotherapy for locally advanced non-small cell lung cancer;",
            "criterions": [
                {
                    "exact_snippets": "unresectable",
                    "criterion": "tumor resectability",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "radical radiotherapy",
                    "criterion": "treatment history",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "radical radiotherapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced non-small cell lung cancer",
                    "criterion": "cancer type and stage",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "non-small cell lung cancer"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": "locally advanced"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Documentation of EGFR sensitive mutations detected from tumor tissue or blood samples;",
            "criterions": [
                {
                    "exact_snippets": "EGFR sensitive mutations detected from tumor tissue or blood samples",
                    "criterion": "EGFR sensitive mutations",
                    "requirements": [
                        {
                            "requirement_type": "detection",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Consent to provide archived tumor tissue samples or fresh tissue samples of primary or metastatic lesions at or after diagnosis for testing, including EGFR mutation type;",
            "criterions": [
                {
                    "exact_snippets": "Consent to provide archived tumor tissue samples or fresh tissue samples",
                    "criterion": "tumor tissue samples",
                    "requirements": [
                        {
                            "requirement_type": "consent",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "EGFR mutation type",
                    "criterion": "EGFR mutation",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "EGFR"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. At least one measurable lesion meeting the RECIST v1.1 definition was required;",
            "criterions": [
                {
                    "exact_snippets": "At least one measurable lesion meeting the RECIST v1.1 definition",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        },
                        {
                            "requirement_type": "definition",
                            "expected_value": "RECIST v1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. ECOG 0 or 1;",
            "criterions": [
                {
                    "exact_snippets": "ECOG 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;",
            "criterions": [
                {
                    "exact_snippets": "The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0",
                    "criterion": "toxicity of previous antineoplastic therapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;",
            "criterions": [
                {
                    "exact_snippets": "No severe cardiac dysfunction",
                    "criterion": "cardiac dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "left ventricular ejection fraction ≥50%",
                    "criterion": "left ventricular ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. The organ function level must meet the requirements on the premise that blood transfusion and colony-stimulating factor are not allowed within 14 days before the screening period;",
            "criterions": [
                {
                    "exact_snippets": "organ function level must meet the requirements",
                    "criterion": "organ function level",
                    "requirements": [
                        {
                            "requirement_type": "requirements",
                            "expected_value": "must meet"
                        }
                    ]
                },
                {
                    "exact_snippets": "blood transfusion ... are not allowed within 14 days before the screening period",
                    "criterion": "blood transfusion",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "not allowed within 14 days before the screening period"
                        }
                    ]
                },
                {
                    "exact_snippets": "colony-stimulating factor are not allowed within 14 days before the screening period",
                    "criterion": "colony-stimulating factor",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "not allowed within 14 days before the screening period"
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Urinary protein ≤2+ or < 1000mg/24h;",
            "criterions": [
                {
                    "exact_snippets": "Urinary protein ≤2+",
                    "criterion": "urinary protein level",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "+"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Urinary protein ... < 1000mg/24h",
                    "criterion": "urinary protein excretion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1000,
                                "unit": "mg/24h"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, serum pregnancy must be negative, and the patient must not be lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.",
            "criterions": [
                {
                    "exact_snippets": "premenopausal women of childbearing potential",
                    "criterion": "premenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "a pregnancy test must be performed within 7 days before the initiation of treatment",
                    "criterion": "pregnancy test timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum pregnancy must be negative",
                    "criterion": "serum pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "the patient must not be lactating",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "throughout the treatment cycle and for 6 months after the end of treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Previous histologic or cytological evidence of small cell or mixed small/non-small cell components;",
            "criterions": [
                {
                    "exact_snippets": "Previous histologic or cytological evidence of small cell or mixed small/non-small cell components",
                    "criterion": "small cell or mixed small/non-small cell components",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients with previous systemic therapy;",
            "criterions": [
                {
                    "exact_snippets": "Patients with previous systemic therapy",
                    "criterion": "previous systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients had received EGFR-TKI therapy;",
            "criterions": [
                {
                    "exact_snippets": "Patients had received EGFR-TKI therapy",
                    "criterion": "EGFR-TKI therapy",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Studies received radical radiotherapy, major surgery, and large area radiotherapy within 4 weeks before randomization;",
            "criterions": [
                {
                    "exact_snippets": "received radical radiotherapy ... within 4 weeks before randomization",
                    "criterion": "radical radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "received ... major surgery ... within 4 weeks before randomization",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "received ... large area radiotherapy within 4 weeks before randomization",
                    "criterion": "large area radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. History of severe heart disease and cerebrovascular disease;",
            "criterions": [
                {
                    "exact_snippets": "History of severe heart disease",
                    "criterion": "heart disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... cerebrovascular disease",
                    "criterion": "cerebrovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;",
            "criterions": [
                {
                    "exact_snippets": "Unstable thrombotic events requiring therapeutic intervention within 6 months before screening",
                    "criterion": "unstable thrombotic events",
                    "requirements": [
                        {
                            "requirement_type": "therapeutic intervention",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Infusion-related thrombosis was excluded",
                    "criterion": "infusion-related thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;",
            "criterions": [
                {
                    "exact_snippets": "QT prolongation",
                    "criterion": "QT prolongation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "complete left bundle branch block",
                    "criterion": "complete left bundle branch block",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "III degree atrioventricular block",
                    "criterion": "III degree atrioventricular block",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "frequent and uncontrollable arrhythmia",
                    "criterion": "arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": "frequent"
                        },
                        {
                            "requirement_type": "controllability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Were diagnosed with active malignancy within 3 years before randomization;",
            "criterions": [
                {
                    "exact_snippets": "diagnosed with active malignancy within 3 years before randomization",
                    "criterion": "active malignancy diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Patients with poor glycemic control;",
            "criterions": [
                {
                    "exact_snippets": "poor glycemic control",
                    "criterion": "glycemic control",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "poor"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. A history of ILD requiring steroid therapy, or current ILD or grade ≥2 radiation pneumonitis, or a suspicion of such disease;",
            "criterions": [
                {
                    "exact_snippets": "A history of ILD requiring steroid therapy",
                    "criterion": "history of ILD",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "steroid therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "current ILD",
                    "criterion": "current ILD",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "grade ≥2 radiation pneumonitis",
                    "criterion": "radiation pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "a suspicion of such disease",
                    "criterion": "suspicion of ILD or radiation pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "suspicion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;",
            "criterions": [
                {
                    "exact_snippets": "Complicated with pulmonary diseases",
                    "criterion": "pulmonary diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically severe respiratory function impairment",
                    "criterion": "respiratory function impairment",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Patients with active central nervous system metastasis;",
            "criterions": [
                {
                    "exact_snippets": "active central nervous system metastasis",
                    "criterion": "central nervous system metastasis",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Had a severe infection within 4 weeks before randomization;",
            "criterions": [
                {
                    "exact_snippets": "Had a severe infection within 4 weeks before randomization",
                    "criterion": "severe infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Patients with massive or symptomatic effusions or poorly controlled effusions;",
            "criterions": [
                {
                    "exact_snippets": "massive or symptomatic effusions",
                    "criterion": "effusions",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "massive",
                                "symptomatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "poorly controlled effusions",
                    "criterion": "effusions",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Imaging examination showed that the tumor had invaded or enveloped the large blood vessels in the abdomen, chest, neck, and pharynx;",
            "criterions": [
                {
                    "exact_snippets": "tumor had invaded or enveloped the large blood vessels in the abdomen",
                    "criterion": "tumor invasion/envelopment of large blood vessels in the abdomen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor had invaded or enveloped the large blood vessels in the ... chest",
                    "criterion": "tumor invasion/envelopment of large blood vessels in the chest",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor had invaded or enveloped the large blood vessels in the ... neck",
                    "criterion": "tumor invasion/envelopment of large blood vessels in the neck",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor had invaded or enveloped the large blood vessels in the ... pharynx",
                    "criterion": "tumor invasion/envelopment of large blood vessels in the pharynx",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Serious unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent;",
            "criterions": [
                {
                    "exact_snippets": "Serious unhealed wound",
                    "criterion": "wound",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "unhealed"
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "ulcer",
                    "criterion": "ulcer",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "unhealed"
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "fracture",
                    "criterion": "fracture",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "unhealed"
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 4 weeks before signing the informed consent",
                    "criterion": "time since condition",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;",
            "criterions": [
                {
                    "exact_snippets": "clinically significant bleeding",
                    "criterion": "clinically significant bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "obvious bleeding tendency",
                    "criterion": "obvious bleeding tendency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "19. Patients with a history of inflammatory bowel disease, extensive bowel resection, immune enteritis, intestinal obstruction or chronic diarrhea;",
            "criterions": [
                {
                    "exact_snippets": "history of inflammatory bowel disease",
                    "criterion": "inflammatory bowel disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "extensive bowel resection",
                    "criterion": "extensive bowel resection",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "immune enteritis",
                    "criterion": "immune enteritis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "intestinal obstruction",
                    "criterion": "intestinal obstruction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic diarrhea",
                    "criterion": "chronic diarrhea",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "20. Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of BL-B01D1;",
            "criterions": [
                {
                    "exact_snippets": "history of allergy to recombinant humanized antibodies",
                    "criterion": "allergy to recombinant humanized antibodies",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of allergy ... to any of the excipients of BL-B01D1",
                    "criterion": "allergy to excipients of BL-B01D1",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "21. Had autologous or allogeneic stem cell transplantation history;",
            "criterions": [
                {
                    "exact_snippets": "autologous or allogeneic stem cell transplantation history",
                    "criterion": "stem cell transplantation history",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "autologous",
                                "allogeneic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "22. Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection;",
            "criterions": [
                {
                    "exact_snippets": "Human immunodeficiency virus antibody positive",
                    "criterion": "HIV antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active hepatitis B virus infection",
                    "criterion": "hepatitis B virus infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis C virus infection",
                    "criterion": "hepatitis C virus infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "23. A history of severe neurological or psychiatric illness;",
            "criterions": [
                {
                    "exact_snippets": "A history of severe neurological ... illness",
                    "criterion": "neurological illness",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "A history of severe ... psychiatric illness",
                    "criterion": "psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "24. Received other unmarketed investigational drugs or treatments within 4 weeks before randomization;",
            "criterions": [
                {
                    "exact_snippets": "Received other unmarketed investigational drugs or treatments within 4 weeks before randomization",
                    "criterion": "receipt of unmarketed investigational drugs or treatments",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "25. Subjects scheduled for vaccination or who received live vaccine within 28 days before study randomization;",
            "criterions": [
                {
                    "exact_snippets": "Subjects scheduled for vaccination",
                    "criterion": "vaccination schedule",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "received live vaccine within 28 days before study randomization",
                    "criterion": "live vaccine administration",
                    "requirements": [
                        {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "26. Other circumstances in which the investigator considered it inappropriate to participate in the trial because of complications or other circumstances.",
            "criterions": [
                {
                    "exact_snippets": "Other circumstances ... inappropriate to participate ... complications or other circumstances.",
                    "criterion": "appropriateness to participate",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "9. Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure &gt; 150 mmHg or diastolic blood pressure &gt; 100 mmHg);",
            "criterions": [
                {
                    "exact_snippets": "Hypertension poorly controlled by two antihypertensive drugs",
                    "criterion": "hypertension control",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled by two antihypertensive drugs"
                        }
                    ]
                },
                {
                    "exact_snippets": "systolic blood pressure > 150 mmHg",
                    "criterion": "systolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 150,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "diastolic blood pressure > 100 mmHg",
                    "criterion": "diastolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 100,
                                "unit": "mmHg"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}