{
    "info": {
        "nct_id": "NCT05508620",
        "official_title": "A Phase Ib Study to Evaluate the Safety and Efficacy of Sirolimus for Injection (Albumin-bound) in Patients With Malignant Solid Tumors With TSC1/2 Genetic Alterations",
        "inclusion_criteria": "* Patients must have histologically or cytologically confirmed diagnosis of malignant solid tumors, with TSC1 or TSC2 genetic alterations, and have no standard treatment or have failed standard treatments.\n* Patients must have archival tumor tissues or agreed to have a tumor biopsy (if not, the sponsor's consent is required for enrollment).\n* At least 1 measurable lesion as defined by RECIST 1.1.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.\n* Life expectancy of ≥3 months.\n* Adequate marrow and organ function.\n* Fasting serum triglyceride must be <300 mg/dL or <3.42 mmol/L; fasting serum cholesterol must be<350 mg/dL or <9.07 mmol/L.\n* Fasting blood glucose must be<6.1 mmol/L and HbA1c< 6.5% in dose escalation, in other stage must be < 7.8 mmol/L and be< 8% respectively.\n* Women of child-bearing potential, or men whose partners are women of childbearing age must agree to use reliable contraceptive methods during the trial period and at least 6 months after the last administration; women of childbearing age must have a negative serum pregnancy test within 7 days prior to the first administration, should not be breast feeding.\n* Patients should understand and willingness to sign a written informed consent form prior to study entry.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Prior treatment with an mTOR inhibitor.\n* Anti-tumor treatment within 4 weeks prior to first dose of study treatment.\n* Participation in another therapeutic clinical trial with 4 weeks before study treatment.\n* Major surgery within 4 weeks prior to study treatment, or have not fully recovered from any previous procedure.\n* Unresolved toxicity from prior anti-tumor therapy greater than Grade 1 as per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.\n* Patients with primary brain tumors or PEComa.\n* Active uncontrolled or symptomatic central nervous system metastasis (CNS) or meningeal metastasis.\n* History of serious cardiovascular disease.\n* History of serious lung disease, such as interstitial lung disease and/or pneumonitis, or pulmonary hypertension, or pre-existing severely impaired lung function.\n* Hydrothorax, ascites or pleural effusion with clinical symptoms or required treatment.\n* Patients with hepatocellular carcinoma (HCC): Child-Pugh class B or C; or HCC with ≥50% liver occupation; or has a history or current evidence of hepatic encephalopathy; portal vein invasion at the main portal branch (Vp4).\n* Live vaccine (including live attenuated vaccine) within 30 days before signing the informed consent.\n* Infection that required systemic anti-infective therapy within 2 weeks before enrollment.\n* History of autoimmune disease or immunodeficiency disease.\n* Active Hepatitis B or Hepatitis C.\n* Use of strong inhibitors or inducers of CYP3A4 within 2 weeks prior to start of treatment initiation, or requiring concomitant treatment during the study.\n* Other server disease that may increase the risk of patients, or interfere the compliance of study procedures, or other reasons which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients must have histologically or cytologically confirmed diagnosis of malignant solid tumors, with TSC1 or TSC2 genetic alterations, and have no standard treatment or have failed standard treatments.",
            "criterions": [
                {
                    "exact_snippets": "histologically or cytologically confirmed diagnosis of malignant solid tumors",
                    "criterion": "malignant solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "TSC1 or TSC2 genetic alterations",
                    "criterion": "TSC1 or TSC2 genetic alterations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no standard treatment or have failed standard treatments",
                    "criterion": "standard treatment",
                    "requirements": [
                        {
                            "requirement_type": "availability or success",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have archival tumor tissues or agreed to have a tumor biopsy (if not, the sponsor's consent is required for enrollment).",
            "criterions": [
                {
                    "exact_snippets": "archival tumor tissues",
                    "criterion": "archival tumor tissues",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "agreed to have a tumor biopsy",
                    "criterion": "tumor biopsy agreement",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sponsor's consent is required for enrollment",
                    "criterion": "sponsor's consent",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": "required for enrollment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 1 measurable lesion as defined by RECIST 1.1.",
            "criterions": [
                {
                    "exact_snippets": "At least 1 measurable lesion",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 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": "* Adequate marrow and organ function.",
            "criterions": [
                {
                    "exact_snippets": "Adequate marrow",
                    "criterion": "marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fasting serum triglyceride must be <300 mg/dL or <3.42 mmol/L; fasting serum cholesterol must be<350 mg/dL or <9.07 mmol/L.",
            "criterions": [
                {
                    "exact_snippets": "Fasting serum triglyceride must be <300 mg/dL or <3.42 mmol/L",
                    "criterion": "fasting serum triglyceride",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 300,
                                        "unit": "mg/dL"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 3.42,
                                        "unit": "mmol/L"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "fasting serum cholesterol must be<350 mg/dL or <9.07 mmol/L",
                    "criterion": "fasting serum cholesterol",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 350,
                                        "unit": "mg/dL"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 9.07,
                                        "unit": "mmol/L"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fasting blood glucose must be<6.1 mmol/L and HbA1c< 6.5% in dose escalation, in other stage must be < 7.8 mmol/L and be< 8% respectively.",
            "criterions": [
                {
                    "exact_snippets": "Fasting blood glucose must be<6.1 mmol/L ... in other stage must be < 7.8 mmol/L",
                    "criterion": "fasting blood glucose",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 6.1,
                                        "unit": "mmol/L"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 7.8,
                                        "unit": "mmol/L"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "HbA1c< 6.5% ... in other stage must ... be< 8%",
                    "criterion": "HbA1c",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 6.5,
                                        "unit": "%"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 8,
                                        "unit": "%"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of child-bearing potential, or men whose partners are women of childbearing age must agree to use reliable contraceptive methods during the trial period and at least 6 months after the last administration; women of childbearing age must have a negative serum pregnancy test within 7 days prior to the first administration, should not be breast feeding.",
            "criterions": [
                {
                    "exact_snippets": "Women of child-bearing potential, or men whose partners are women of childbearing age must agree to use reliable contraceptive methods during the trial period and at least 6 months after the last administration",
                    "criterion": "contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "women of childbearing age must have a negative serum pregnancy test within 7 days prior to the first administration",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "women of childbearing age ... should not be breast feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients should understand and willingness to sign a written informed consent form prior to study entry.",
            "criterions": [
                {
                    "exact_snippets": "understand and willingness to sign a written informed consent form",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "understanding",
                            "expected_value": true
                        },
                        {
                            "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": "* Prior treatment with an mTOR inhibitor.",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with an mTOR inhibitor.",
                    "criterion": "mTOR inhibitor treatment",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Anti-tumor treatment within 4 weeks prior to first dose of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Anti-tumor treatment within 4 weeks prior to first dose of study treatment.",
                    "criterion": "anti-tumor treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participation in another therapeutic clinical trial with 4 weeks before study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Participation in another therapeutic clinical trial with 4 weeks before study treatment.",
                    "criterion": "participation in another therapeutic clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "time since participation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major surgery within 4 weeks prior to study treatment, or have not fully recovered from any previous procedure.",
            "criterions": [
                {
                    "exact_snippets": "Major surgery within 4 weeks prior to study treatment",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "have not fully recovered from any previous procedure",
                    "criterion": "recovery from previous procedure",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unresolved toxicity from prior anti-tumor therapy greater than Grade 1 as per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.",
            "criterions": [
                {
                    "exact_snippets": "Unresolved toxicity from prior anti-tumor therapy greater than Grade 1 as per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.",
                    "criterion": "unresolved toxicity from prior anti-tumor therapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "Grade (CTCAE v5.0)"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with primary brain tumors or PEComa.",
            "criterions": [
                {
                    "exact_snippets": "primary brain tumors",
                    "criterion": "primary brain tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "PEComa",
                    "criterion": "PEComa",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active uncontrolled or symptomatic central nervous system metastasis (CNS) or meningeal metastasis.",
            "criterions": [
                {
                    "exact_snippets": "Active uncontrolled or symptomatic central nervous system metastasis (CNS)",
                    "criterion": "central nervous system metastasis",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "symptom presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "meningeal metastasis",
                    "criterion": "meningeal metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of serious cardiovascular disease.",
            "criterions": [
                {
                    "exact_snippets": "History of serious cardiovascular disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of serious lung disease, such as interstitial lung disease and/or pneumonitis, or pulmonary hypertension, or pre-existing severely impaired lung function.",
            "criterions": [
                {
                    "exact_snippets": "History of serious lung disease, such as interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of serious lung disease, such as ... pneumonitis",
                    "criterion": "pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of serious lung disease, such as ... pulmonary hypertension",
                    "criterion": "pulmonary hypertension",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... pre-existing severely impaired lung function",
                    "criterion": "severely impaired lung function",
                    "requirements": [
                        {
                            "requirement_type": "pre-existing",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hydrothorax, ascites or pleural effusion with clinical symptoms or required treatment.",
            "criterions": [
                {
                    "exact_snippets": "Hydrothorax, ascites or pleural effusion",
                    "criterion": "hydrothorax",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Hydrothorax, ascites or pleural effusion",
                    "criterion": "ascites",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Hydrothorax, ascites or pleural effusion",
                    "criterion": "pleural effusion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical symptoms",
                    "criterion": "clinical symptoms",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "required treatment",
                    "criterion": "required treatment",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with hepatocellular carcinoma (HCC): Child-Pugh class B or C; or HCC with ≥50% liver occupation; or has a history or current evidence of hepatic encephalopathy; portal vein invasion at the main portal branch (Vp4).",
            "criterions": [
                {
                    "exact_snippets": "hepatocellular carcinoma (HCC)",
                    "criterion": "hepatocellular carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Child-Pugh class B or C",
                    "criterion": "Child-Pugh class",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": [
                                "B",
                                "C"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "HCC with ≥50% liver occupation",
                    "criterion": "liver occupation by HCC",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "history or current evidence of hepatic encephalopathy",
                    "criterion": "hepatic encephalopathy",
                    "requirements": [
                        {
                            "requirement_type": "history or current evidence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "portal vein invasion at the main portal branch (Vp4)",
                    "criterion": "portal vein invasion",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "main portal branch (Vp4)"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Live vaccine (including live attenuated vaccine) within 30 days before signing the informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Live vaccine (including live attenuated vaccine) within 30 days before signing the informed consent.",
                    "criterion": "live vaccine",
                    "requirements": [
                        {
                            "requirement_type": "administration time",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "days before signing the informed consent"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Infection that required systemic anti-infective therapy within 2 weeks before enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Infection that required systemic anti-infective therapy within 2 weeks before enrollment.",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic anti-infective therapy"
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 2 weeks before enrollment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of autoimmune disease or immunodeficiency disease.",
            "criterions": [
                {
                    "exact_snippets": "History of autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... immunodeficiency disease",
                    "criterion": "immunodeficiency disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active Hepatitis B or Hepatitis C.",
            "criterions": [
                {
                    "exact_snippets": "Active Hepatitis B",
                    "criterion": "Hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "Active ... Hepatitis C",
                    "criterion": "Hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of strong inhibitors or inducers of CYP3A4 within 2 weeks prior to start of treatment initiation, or requiring concomitant treatment during the study.",
            "criterions": [
                {
                    "exact_snippets": "Use of strong inhibitors or inducers of CYP3A4 within 2 weeks prior to start of treatment initiation",
                    "criterion": "use of strong inhibitors or inducers of CYP3A4",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 2 weeks prior to start of treatment initiation"
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring concomitant treatment during the study",
                    "criterion": "use of strong inhibitors or inducers of CYP3A4",
                    "requirements": [
                        {
                            "requirement_type": "concomitant treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other server disease that may increase the risk of patients, or interfere the compliance of study procedures, or other reasons which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.",
            "criterions": [
                {
                    "exact_snippets": "Other server disease that may increase the risk of patients",
                    "criterion": "other severe disease",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": "increase"
                        }
                    ]
                },
                {
                    "exact_snippets": "interfere the compliance of study procedures",
                    "criterion": "interference with compliance",
                    "requirements": [
                        {
                            "requirement_type": "interference",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other reasons which, in the judgment of the investigator, would make the patient inappropriate for entry into this study",
                    "criterion": "investigator judgment",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness for study",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}