{
    "info": {
        "nct_id": "NCT06121401",
        "official_title": "A Phase IV Trial to Confirm the Efficacy of Olaparib in Combination With Bevacizumab as Frontline Treatment of HRD Positive Ovarian Tumors",
        "inclusion_criteria": "1. Patient who has completed first line platinum-taxane chemotherapy\n2. Patient on treatment with bevacizumab (patient must have received at least 1 cycle of bevacizumab in combination with chemotherapy). Bevacizumab treatment should have been administered at a dose of 15mg/kg q3 weeks.\n3. Patient must be without evidence of disease (NED) or in complete response (CR) or partial response (PR) from her first line treatment.\n4. Patients with histologically confirmed high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer and HRD-positive tumor according to the Myriad Mychoice CDx Plus evaluation.\n5. Patients must have normal organ and bone marrow function values measured within 28 days before administration of olaparib\n6. Normal blood pressure (BP) or adequately treated and controlled hypertension (systolic BP ≤ 140 mmHg and/or diastolic BP ≤ 90 mmHg\n\n8. Patients must have a life expectancy ≥ 16 weeks. 9. Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of olaparib administration and confirmed the day of treatment start.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Persistent toxicities (Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia\n2. Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML.\n3. Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required\n4. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.\n5. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.\n6. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).\n7. Patients with known active hepatitis (i.e. Hepatitis B or C).\n8. Any previous treatment with PARP inhibitor, including Olaparib.\n9. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to olaparib.\n10. Major surgery within 2 weeks of starting olaparib and patients must have recovered from any effects of any major surgery\n11. Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy is permitted as are steroidal antiemetics).\n12. Concomitant use of known strong CYP3A inhibitors\n13. Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers\n14. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).\n15. Patients with a known hypersensitivity to olaparib or any of the excipients of the product.\n16. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of olaparib or puts the patient at high risk for treatment-related complications.\n17. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.\n18. Breast feeding and pregnant women",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Patient who has completed first line platinum-taxane chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Patient who has completed first line platinum-taxane chemotherapy",
                    "criterion": "platinum-taxane chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "line",
                            "expected_value": "first"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patient on treatment with bevacizumab (patient must have received at least 1 cycle of bevacizumab in combination with chemotherapy). Bevacizumab treatment should have been administered at a dose of 15mg/kg q3 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Patient on treatment with bevacizumab",
                    "criterion": "bevacizumab treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patient must have received at least 1 cycle of bevacizumab in combination with chemotherapy",
                    "criterion": "bevacizumab treatment",
                    "requirements": [
                        {
                            "requirement_type": "cycle count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "cycle"
                            }
                        },
                        {
                            "requirement_type": "combination",
                            "expected_value": "chemotherapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "Bevacizumab treatment should have been administered at a dose of 15mg/kg q3 weeks",
                    "criterion": "bevacizumab treatment",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": "15mg/kg q3 weeks"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patient must be without evidence of disease (NED) or in complete response (CR) or partial response (PR) from her first line treatment.",
            "criterions": [
                {
                    "exact_snippets": "without evidence of disease (NED)",
                    "criterion": "evidence of disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "in complete response (CR)",
                    "criterion": "response to first line treatment",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "complete response"
                        }
                    ]
                },
                {
                    "exact_snippets": "partial response (PR)",
                    "criterion": "response to first line treatment",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "partial response"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients with histologically confirmed high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer and HRD-positive tumor according to the Myriad Mychoice CDx Plus evaluation.",
            "criterions": [
                {
                    "exact_snippets": "histologically confirmed high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "high-grade epithelial ovarian",
                                "fallopian tube",
                                "primary peritoneal"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "HRD-positive tumor according to the Myriad Mychoice CDx Plus evaluation",
                    "criterion": "HRD status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patients must have normal organ and bone marrow function values measured within 28 days before administration of olaparib",
            "criterions": [
                {
                    "exact_snippets": "normal organ and bone marrow function values",
                    "criterion": "organ and bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "measured within 28 days before administration of olaparib",
                    "criterion": "measurement timing",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 28 days before administration of olaparib"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Normal blood pressure (BP) or adequately treated and controlled hypertension (systolic BP ≤ 140 mmHg and/or diastolic BP ≤ 90 mmHg",
            "criterions": [
                {
                    "exact_snippets": "Normal blood pressure (BP)",
                    "criterion": "blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated and controlled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated and controlled"
                        }
                    ]
                },
                {
                    "exact_snippets": "systolic BP ≤ 140 mmHg",
                    "criterion": "systolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 140,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "diastolic BP ≤ 90 mmHg",
                    "criterion": "diastolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 90,
                                "unit": "mmHg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patients must have a life expectancy ≥ 16 weeks. 9. Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of olaparib administration and confirmed the day of treatment start.",
            "criterions": [
                {
                    "exact_snippets": "life expectancy ≥ 16 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 16,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Postmenopausal or evidence of non-childbearing status",
                    "criterion": "menopausal status or non-childbearing status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "postmenopausal",
                                "non-childbearing"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "negative urine or serum pregnancy test within 28 days of olaparib administration and confirmed the day of treatment start",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 28 days of olaparib administration and confirmed the day of treatment start"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "2. Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML.",
            "criterions": [
                {
                    "exact_snippets": "Patients with myelodysplastic syndrome",
                    "criterion": "myelodysplastic syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "acute myeloid leukaemia",
                    "criterion": "acute myeloid leukaemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "features suggestive of MDS/AML",
                    "criterion": "features suggestive of MDS/AML",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required",
            "criterions": [
                {
                    "exact_snippets": "Patients with symptomatic uncontrolled brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.",
            "criterions": [
                {
                    "exact_snippets": "serious, uncontrolled medical disorder",
                    "criterion": "medical disorder",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "non-malignant systemic disease",
                    "criterion": "systemic disease",
                    "requirements": [
                        {
                            "requirement_type": "malignancy",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "active, uncontrolled infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.",
            "criterions": [
                {
                    "exact_snippets": "Patients unable to swallow orally administered medication",
                    "criterion": "ability to swallow orally administered medication",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with gastrointestinal disorders likely to interfere with absorption of the study medication",
                    "criterion": "gastrointestinal disorders",
                    "requirements": [
                        {
                            "requirement_type": "interference with absorption of the study medication",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).",
            "criterions": [
                {
                    "exact_snippets": "Immunocompromised patients",
                    "criterion": "immunocompromised status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "serologically positive for human immunodeficiency virus (HIV)",
                    "criterion": "HIV serological status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Patients with known active hepatitis (i.e. Hepatitis B or C).",
            "criterions": [
                {
                    "exact_snippets": "Patients with known active hepatitis (i.e. Hepatitis B or C)",
                    "criterion": "hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Any previous treatment with PARP inhibitor, including Olaparib.",
            "criterions": [
                {
                    "exact_snippets": "Any previous treatment with PARP inhibitor, including Olaparib.",
                    "criterion": "previous treatment with PARP inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to olaparib.",
            "criterions": [
                {
                    "exact_snippets": "Patients receiving any systemic chemotherapy",
                    "criterion": "systemic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients receiving any ... radiotherapy (except for palliative reasons)",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "within 3 weeks prior to olaparib",
                    "criterion": "time since last treatment",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Major surgery within 2 weeks of starting olaparib and patients must have recovered from any effects of any major surgery",
            "criterions": [
                {
                    "exact_snippets": "Major surgery within 2 weeks of starting olaparib",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients must have recovered from any effects of any major surgery",
                    "criterion": "recovery from major surgery",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy is permitted as are steroidal antiemetics).",
            "criterions": [
                {
                    "exact_snippets": "Administration of other simultaneous chemotherapy drugs",
                    "criterion": "simultaneous chemotherapy drugs",
                    "requirements": [
                        {
                            "requirement_type": "administration",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any other anticancer therapy",
                    "criterion": "anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "administration",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "anti-neoplastic hormonal therapy",
                    "criterion": "anti-neoplastic hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "administration",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "simultaneous radiotherapy during the trial treatment period",
                    "criterion": "simultaneous radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "administration",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Concomitant use of known strong CYP3A inhibitors",
            "criterions": [
                {
                    "exact_snippets": "Concomitant use of known strong CYP3A inhibitors",
                    "criterion": "use of CYP3A inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "concomitance",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "strength",
                            "expected_value": "strong"
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers",
            "criterions": [
                {
                    "exact_snippets": "Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) ... CYP3A inducers",
                    "criterion": "concomitant use of strong CYP3A inducers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Concomitant use of ... moderate CYP3A inducers",
                    "criterion": "concomitant use of moderate CYP3A inducers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).",
            "criterions": [
                {
                    "exact_snippets": "Previous allogenic bone marrow transplant",
                    "criterion": "allogenic bone marrow transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "double umbilical cord blood transplantation (dUCBT)",
                    "criterion": "double umbilical cord blood transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Patients with a known hypersensitivity to olaparib or any of the excipients of the product.",
            "criterions": [
                {
                    "exact_snippets": "known hypersensitivity to olaparib",
                    "criterion": "hypersensitivity to olaparib",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... any of the excipients of the product",
                    "criterion": "hypersensitivity to excipients of the product",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of olaparib or puts the patient at high risk for treatment-related complications.",
            "criterions": [
                {
                    "exact_snippets": "Evidence of any other disease",
                    "criterion": "other disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "metabolic dysfunction",
                    "criterion": "metabolic dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "physical examination finding",
                    "criterion": "physical examination finding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "laboratory finding",
                    "criterion": "laboratory finding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "disease or condition that contraindicates the use of olaparib",
                    "criterion": "contraindication to olaparib",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "puts the patient at high risk for treatment-related complications",
                    "criterion": "high risk for treatment-related complications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.",
            "criterions": [
                {
                    "exact_snippets": "unlikely to comply with study procedures, restrictions and requirements",
                    "criterion": "compliance with study procedures, restrictions and requirements",
                    "requirements": [
                        {
                            "requirement_type": "likelihood",
                            "expected_value": "likely"
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Breast feeding and pregnant women",
            "criterions": [
                {
                    "exact_snippets": "Breast feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "pregnant women",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "1. Persistent toxicities (Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia",
            "criterions": [
                {
                    "exact_snippets": "Persistent toxicities ... CTCAE grade 2",
                    "criterion": "persistent toxicities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "CTCAE grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "caused by previous cancer therapy",
                    "criterion": "cause of toxicities",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "previous cancer therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding alopecia",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}