{
    "info": {
        "nct_id": "NCT06011291",
        "official_title": "A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SYH2051 Monotherapy in Patients With Advanced Solid Tumors or in Combination With Radiotherapy in Patients With Locally Advanced Head and Neck Cancer",
        "inclusion_criteria": "1. Age ≥18 years old, male or female;\n2. Phase Ia: Patients with histologically or cytologically confirmed advanced solid tumors, for whom there is no standard therapy available, or ineffective or intolerant to standard therapy. Phase Ib/Ic: Patients with histologically or cytologically confirmed locally advanced head and neck cancer suitable for radiotherapy alone;\n3. Eastern Collaborative Oncology Group (ECOG) Performance Status of 0~1;\n4. Patients in medical conditions to be able to receive radiotherapy (for phase Ib/Ic);\n5. Life expectancy of >3 months;\n6. At least one measurable lesion (excluding patients in phase Ic combined with adjuvant radiotherapy);\n7. Patients with adequate hematologic, hepatic, renal and coagulation function;\n8. Patients are not pregnant or lactating and required contraception;\n9. Patients who are willing to provide written informed consent form (ICF) before the beginning of the study.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Any antineoplastic therapy such as chemotherapy, biologic therapy, endocrine therapy, or immunotherapy within 4 weeks before the first dose of the study drug (or within 5 half-lives of other unmarketed study drugs, whichever is longer), except for the following:\n\n   1. 6 weeks for Nitrosoureas or mitomycin C;\n   2. 2 weeks or five half-lives (whichever is longer) for oral fluorouracil and small molecule targeted drugs;\n   3. 2 weeks for Chinese herbal medicine with antineoplastic indications;\n2. Patients with previous (within 2 years before screening) or concurrent other malignancies (only for phase Ib/Ic);\n3. Patients had undergone major organ surgery (excluding needle biopsies) within 4 weeks before the first dose, with obvious trauma, or require elective surgery during the study;\n4. Severe, non-healing fractures within 4 weeks before the first dose of the study drug;\n5. The adverse reactions of previous antineoplastic therapy have not recovered to ≤grade 1 as determined by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria;\n6. Patients who had received treatment with any drug that is a medium or strong inhibitor or inducer of cytochrome P450 (CYP) 3A4/5 enzyme activity within 2 weeks before screening or need to continue receiving such drugs;\n7. Active brain metastases and/or carcinomatous meningitis;\n8. Concurrent serious and/or uncontrolled medical conditions at screening (e.g., severe chronic obstructive pulmonary disease);\n9. Patients with abnormal thyroid function were not allowed, except those with euthyroid function after drug control;\n10. History of severe cardiovascular disease;\n11. History of myopathy or raised creatine kinase (CK) >5 times the upper limit of normal (ULN);\n12. Known hypersensitivity or intolerance to any component of the study drug or its excipients;\n13. History of autoimmune disease, immunodeficiency disease, including HIV testing positive or other acquired, congenital immunodeficiency diseases, or organ transplantation;\n14. Active hepatitis B virus, hepatitis C virus or active syphilis infection;\n15. Active dysphagia, malabsorption or other chronic gastrointestinal diseases or conditions that may hamper compliance and/or absorption of the study drug;\n16. Other ineligibilities according to the investigator.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Age ≥18 years old, male or female;",
            "criterions": [
                {
                    "exact_snippets": "Age ≥18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Phase Ia: Patients with histologically or cytologically confirmed advanced solid tumors, for whom there is no standard therapy available, or ineffective or intolerant to standard therapy. Phase Ib/Ic: Patients with histologically or cytologically confirmed locally advanced head and neck cancer suitable for radiotherapy alone;",
            "criterions": [
                {
                    "exact_snippets": "Phase Ia: Patients with histologically or cytologically confirmed advanced solid tumors",
                    "criterion": "advanced solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Phase Ia: ... for whom there is no standard therapy available",
                    "criterion": "standard therapy availability",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Phase Ia: ... ineffective or intolerant to standard therapy",
                    "criterion": "standard therapy effectiveness or tolerance",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness or tolerance",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Phase Ib/Ic: Patients with histologically or cytologically confirmed locally advanced head and neck cancer",
                    "criterion": "locally advanced head and neck cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Phase Ib/Ic: ... suitable for radiotherapy alone",
                    "criterion": "suitability for radiotherapy alone",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Eastern Collaborative Oncology Group (ECOG) Performance Status of 0~1;",
            "criterions": [
                {
                    "exact_snippets": "Eastern Collaborative Oncology Group (ECOG) Performance Status of 0~1",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients in medical conditions to be able to receive radiotherapy (for phase Ib/Ic);",
            "criterions": [
                {
                    "exact_snippets": "Patients in medical conditions to be able to receive radiotherapy",
                    "criterion": "medical conditions for radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Life expectancy of >3 months;",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of >3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. At least one measurable lesion (excluding patients in phase Ic combined with adjuvant radiotherapy);",
            "criterions": [
                {
                    "exact_snippets": "At least one measurable lesion",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding patients in phase Ic combined with adjuvant radiotherapy",
                    "criterion": "phase Ic combined with adjuvant radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Patients with adequate hematologic, hepatic, renal and coagulation function;",
            "criterions": [
                {
                    "exact_snippets": "adequate hematologic ... function",
                    "criterion": "hematologic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... hepatic ... function",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... renal ... function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... coagulation function",
                    "criterion": "coagulation function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patients are not pregnant or lactating and required contraception;",
            "criterions": [
                {
                    "exact_snippets": "Patients are not pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not ... lactating",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "required contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patients who are willing to provide written informed consent form (ICF) before the beginning of the study.",
            "criterions": [
                {
                    "exact_snippets": "willing to provide written informed consent form (ICF)",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Any antineoplastic therapy such as chemotherapy, biologic therapy, endocrine therapy, or immunotherapy within 4 weeks before the first dose of the study drug (or within 5 half-lives of other unmarketed study drugs, whichever is longer), except for the following:",
            "criterions": [
                {
                    "exact_snippets": "Any antineoplastic therapy such as chemotherapy, biologic therapy, endocrine therapy, or immunotherapy within 4 weeks before the first dose of the study drug",
                    "criterion": "antineoplastic therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "(or within 5 half-lives of other unmarketed study drugs, whichever is longer)",
                    "criterion": "antineoplastic therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": "within 5 half-lives of other unmarketed study drugs, whichever is longer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. 6 weeks for Nitrosoureas or mitomycin C;",
            "criterions": [
                {
                    "exact_snippets": "6 weeks for Nitrosoureas",
                    "criterion": "Nitrosoureas treatment",
                    "requirements": [
                        {
                            "requirement_type": "washout period",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "6 weeks for ... mitomycin C",
                    "criterion": "mitomycin C treatment",
                    "requirements": [
                        {
                            "requirement_type": "washout period",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. 2 weeks or five half-lives (whichever is longer) for oral fluorouracil and small molecule targeted drugs;",
            "criterions": [
                {
                    "exact_snippets": "2 weeks or five half-lives (whichever is longer) for oral fluorouracil",
                    "criterion": "oral fluorouracil washout period",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "2 weeks or five half-lives (whichever is longer)"
                        }
                    ]
                },
                {
                    "exact_snippets": "2 weeks or five half-lives (whichever is longer) for ... small molecule targeted drugs",
                    "criterion": "small molecule targeted drugs washout period",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "2 weeks or five half-lives (whichever is longer)"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. 2 weeks for Chinese herbal medicine with antineoplastic indications;",
            "criterions": [
                {
                    "exact_snippets": "2 weeks for Chinese herbal medicine with antineoplastic indications",
                    "criterion": "Chinese herbal medicine with antineoplastic indications",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients with previous (within 2 years before screening) or concurrent other malignancies (only for phase Ib/Ic);",
            "criterions": [
                {
                    "exact_snippets": "previous (within 2 years before screening) or concurrent other malignancies",
                    "criterion": "other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "previous within 2 years before screening"
                        },
                        {
                            "requirement_type": "concurrent",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients had undergone major organ surgery (excluding needle biopsies) within 4 weeks before the first dose, with obvious trauma, or require elective surgery during the study;",
            "criterions": [
                {
                    "exact_snippets": "Patients had undergone major organ surgery (excluding needle biopsies) within 4 weeks before the first dose",
                    "criterion": "major organ surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "with obvious trauma",
                    "criterion": "obvious trauma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "require elective surgery during the study",
                    "criterion": "elective surgery",
                    "requirements": [
                        {
                            "requirement_type": "requirement during study",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Severe, non-healing fractures within 4 weeks before the first dose of the study drug;",
            "criterions": [
                {
                    "exact_snippets": "Severe, non-healing fractures",
                    "criterion": "fractures",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "healing status",
                            "expected_value": "non-healing"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 4 weeks before the first dose of the study drug",
                    "criterion": "time since fracture",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patients who had received treatment with any drug that is a medium or strong inhibitor or inducer of cytochrome P450 (CYP) 3A4/5 enzyme activity within 2 weeks before screening or need to continue receiving such drugs;",
            "criterions": [
                {
                    "exact_snippets": "received treatment with any drug that is a medium or strong inhibitor or inducer of cytochrome P450 (CYP) 3A4/5 enzyme activity within 2 weeks before screening",
                    "criterion": "treatment with CYP3A4/5 enzyme activity inhibitors or inducers",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 2 weeks before screening"
                        }
                    ]
                },
                {
                    "exact_snippets": "need to continue receiving such drugs",
                    "criterion": "need to continue receiving CYP3A4/5 enzyme activity inhibitors or inducers",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Active brain metastases and/or carcinomatous meningitis;",
            "criterions": [
                {
                    "exact_snippets": "Active brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinomatous meningitis",
                    "criterion": "carcinomatous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Concurrent serious and/or uncontrolled medical conditions at screening (e.g., severe chronic obstructive pulmonary disease);",
            "criterions": [
                {
                    "exact_snippets": "Concurrent serious and/or uncontrolled medical conditions",
                    "criterion": "medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "severe chronic obstructive pulmonary disease",
                    "criterion": "chronic obstructive pulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patients with abnormal thyroid function were not allowed, except those with euthyroid function after drug control;",
            "criterions": [
                {
                    "exact_snippets": "abnormal thyroid function",
                    "criterion": "thyroid function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "abnormal"
                        }
                    ]
                },
                {
                    "exact_snippets": "euthyroid function after drug control",
                    "criterion": "thyroid function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "euthyroid"
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "after drug control"
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. History of severe cardiovascular disease;",
            "criterions": [
                {
                    "exact_snippets": "History of severe cardiovascular disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. History of myopathy or raised creatine kinase (CK) >5 times the upper limit of normal (ULN);",
            "criterions": [
                {
                    "exact_snippets": "History of myopathy",
                    "criterion": "myopathy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "raised creatine kinase (CK) >5 times the upper limit of normal (ULN)",
                    "criterion": "creatine kinase (CK)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "times the upper limit of normal (ULN)"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Known hypersensitivity or intolerance to any component of the study drug or its excipients;",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity or intolerance to any component of the study drug or its excipients",
                    "criterion": "hypersensitivity or intolerance",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. History of autoimmune disease, immunodeficiency disease, including HIV testing positive or other acquired, congenital immunodeficiency diseases, or organ transplantation;",
            "criterions": [
                {
                    "exact_snippets": "History of autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "immunodeficiency disease",
                    "criterion": "immunodeficiency disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HIV testing positive",
                    "criterion": "HIV",
                    "requirements": [
                        {
                            "requirement_type": "testing positive",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "acquired, congenital immunodeficiency diseases",
                    "criterion": "acquired or congenital immunodeficiency diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "organ transplantation",
                    "criterion": "organ transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Active hepatitis B virus, hepatitis C virus or active syphilis infection;",
            "criterions": [
                {
                    "exact_snippets": "Active hepatitis B virus",
                    "criterion": "hepatitis B virus infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis C virus",
                    "criterion": "hepatitis C virus infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active syphilis infection",
                    "criterion": "syphilis infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Active dysphagia, malabsorption or other chronic gastrointestinal diseases or conditions that may hamper compliance and/or absorption of the study drug;",
            "criterions": [
                {
                    "exact_snippets": "Active dysphagia",
                    "criterion": "dysphagia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "malabsorption",
                    "criterion": "malabsorption",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic gastrointestinal diseases or conditions",
                    "criterion": "chronic gastrointestinal diseases or conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Other ineligibilities according to the investigator.",
            "criterions": [
                {
                    "exact_snippets": "Other ineligibilities according to the investigator.",
                    "criterion": "ineligibilities",
                    "requirements": [
                        {
                            "requirement_type": "determination",
                            "expected_value": "according to the investigator"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "5. The adverse reactions of previous antineoplastic therapy have not recovered to ≤grade 1 as determined by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria;",
            "criterions": [
                {
                    "exact_snippets": "adverse reactions of previous antineoplastic therapy have not recovered to ≤grade 1 ... CTCAE v5.0 criteria",
                    "criterion": "recovery from adverse reactions of previous antineoplastic therapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}