{
    "info": {
        "nct_id": "NCT05233982",
        "official_title": "MITO 35a: A Multicenter, Prospective, Single Arm Trial of Olaparib Maintenance Therapy in Newly Diagnosed BRCA Wildtype Advanced Ovarian, Fallopian Tube and Primitive Peritoneal Cancer",
        "inclusion_criteria": "1. Signed informed consent obtained prior to initiation of any study-specific procedures.\n2. Female aged≥18 years old on day of signing informed consent.\n3. Patients with histologically diagnosed advanced stage III-IV according International Federation of Gynaecology and Obstetrics (FIGO), high grade serous or endometrioid, epithelial ovarian cancer (including primary peritoneal or fallopian tube cancer).\n4. Patients with a complete or partial response to first line platinum-based treatment not including Bevacizumab.\n5. Documented absence of somatic and germline mutations of BRCA 1 /2.\n6. Patients must have a life expectancy ≥ 16 weeks.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1, (See Appendix A).\n8. Availability of sufficient formalin-fixed paraffin-embedded (FFPE) tumor tissue from the primary surgery (chemotherapy - naïve patients) for translational analysis. A quality control analysis of samples will be performed before patient's enrollment.\n9. Patients must be enrolled within 8 weeks of the first day of the last dose of chemotherapy.\n10. Patients must be able to take oral medications.\n11. Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on Day 1 Cycle 1.\n\n    Postmenopausal is defined as:\n    * Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments;\n    * Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post-menopausal range for women under 50;\n    * radiation-induced oophorectomy with last menses >1 year ago;\n    * chemotherapy-induced menopause with >1 year interval since last menses;\n    * surgical sterilisation (bilateral oophorectomy or hysterectomy).\n12. Women Women of childbearing potential and their partners, who are sexually active, must agree to the use of one highly effective forms of contraception and their partners must use a male condom (as described in Appendix D). This should be started from the signing of the informed consent and continue throughout the period of taking study treatment and for at least 1 month after last dose of study drug\n13. Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:\n\n    Haemoglobin ≥ 10.0 g/dL with no blood transfusion in the past 28 days; Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; Platelet count ≥ 100 x 109/L; Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be ≤ 5x ULN\n\n    Patients must have creatinine clearance estimated of ≥51 mL/min using the Cockcroft-Gault equation or based on a 24-hour urine test:\n    * Estimated creatinine clearance = (140-age [years]) x weight (kg) (x F) a\n    * serum creatinine (mg/dL) x 72 a where F=0.85 for females\n14. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Patients have received Bevacizumab in concomitance with first line platinum-based therapy.\n2. Clear cell, mucinous and mixed mullerian tumors/carcinosarcoma, non-epithelial tumors or ovarian tumors with low malignant potential (ie. borderline tumors) are not allowed.\n3. Received chemotherapy within 14 days to first dose to study drug and / or persistent toxicities (>Common Terminology Criteria for Adverse Event (CTCAE) version 5.0 grade 2) caused by previous cancer therapy, excluding alopecia, peripheral neuropathy and related effects of prior chemotherapy that are unlikely to be exacerbated by treatment with study drug.\n4. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).\n5. Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable).\n6. Breast feeding women.\n7. Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML.\n8. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection [Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, New York Heart Association (NYHA) grade II or greater congestive heart failure, uncontrolled hypertension, severe peripheral vascular disease, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric illness ]\n9. Patients with active second malignancy.\n10. Other malignancy unless curatively treated with no evidence of disease for ≥5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma.\n11. Any prior treatment for ovarian cancer, other than first line platinum-based therapy, including any maintenance treatment between completion of the platinum regimen and initiation of study drug in this study.\n12. Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.\n13. Concurrent treatment with other investigational agents.\n14. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.\n15. Any positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus, eg. Hepatitis B surface antigen (HBsAg, Australia antigen) positive, or Hepatitis C antibody (anti-HCV) positive (except if HCV-RNA negative).\n16. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).\n17. Patients with symptomatic uncontrolled brain metastases. A TC/RMN scan of brain is required at baseline. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment.\n18. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.\n19. Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (eg., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation < 470 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome.\n20. Evidence of any other medical conditions, physical examination or laboratory findings that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment related complications;\n21. Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.\n22. Concomitant use of known strong (e.g. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.\n23. Patients with a known hypersensitivity to olaparib or any of the excipients of the product;\n24. Presence of any other condition that may increase the risk associated with study participation or may interfere with the interpretation of study results, and in the opinion of the investigator, would make the",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Signed informed consent obtained prior to initiation of any study-specific procedures.",
            "criterions": [
                {
                    "exact_snippets": "Signed informed consent obtained",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "signed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Female aged≥18 years old on day of signing informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "aged≥18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients with histologically diagnosed advanced stage III-IV according International Federation of Gynaecology and Obstetrics (FIGO), high grade serous or endometrioid, epithelial ovarian cancer (including primary peritoneal or fallopian tube cancer).",
            "criterions": [
                {
                    "exact_snippets": "histologically diagnosed",
                    "criterion": "diagnosis method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "histological"
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced stage III-IV according International Federation of Gynaecology and Obstetrics (FIGO)",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "FIGO stage"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "FIGO stage"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "high grade serous or endometrioid",
                    "criterion": "cancer grade and type",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": "high"
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "serous",
                                "endometrioid"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "epithelial ovarian cancer (including primary peritoneal or fallopian tube cancer)",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "epithelial ovarian cancer",
                                "primary peritoneal cancer",
                                "fallopian tube cancer"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients with a complete or partial response to first line platinum-based treatment not including Bevacizumab.",
            "criterions": [
                {
                    "exact_snippets": "complete or partial response to first line platinum-based treatment",
                    "criterion": "response to first line platinum-based treatment",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": [
                                "complete",
                                "partial"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "not including Bevacizumab",
                    "criterion": "Bevacizumab treatment",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Documented absence of somatic and germline mutations of BRCA 1 /2.",
            "criterions": [
                {
                    "exact_snippets": "absence of somatic and germline mutations of BRCA 1 /2",
                    "criterion": "BRCA 1/2 mutations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patients must have a life expectancy ≥ 16 weeks.",
            "criterions": [
                {
                    "exact_snippets": "life expectancy ≥ 16 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 16,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1, (See Appendix A).",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 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": "8. Availability of sufficient formalin-fixed paraffin-embedded (FFPE) tumor tissue from the primary surgery (chemotherapy - naïve patients) for translational analysis. A quality control analysis of samples will be performed before patient's enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Availability of sufficient formalin-fixed paraffin-embedded (FFPE) tumor tissue from the primary surgery",
                    "criterion": "FFPE tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": "sufficient"
                        }
                    ]
                },
                {
                    "exact_snippets": "chemotherapy - naïve patients",
                    "criterion": "chemotherapy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "naïve"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patients must be enrolled within 8 weeks of the first day of the last dose of chemotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be enrolled within 8 weeks of the first day of the last dose of chemotherapy.",
                    "criterion": "enrollment timing",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 8,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Patients must be able to take oral medications.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be able to take oral medications.",
                    "criterion": "ability to take oral medications",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on Day 1 Cycle 1.",
            "criterions": [
                {
                    "exact_snippets": "Postmenopausal or evidence of non-childbearing status",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "postmenopausal",
                                "non-childbearing"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on Day 1 Cycle 1",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 28 days of study treatment and confirmed prior to treatment on Day 1 Cycle 1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Postmenopausal is defined as:",
            "criterions": [
                {
                    "exact_snippets": "Postmenopausal is defined as:",
                    "criterion": "postmenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "postmenopausal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments;",
            "criterions": [
                {
                    "exact_snippets": "Amenorrheic for 1 year or more",
                    "criterion": "amenorrhea",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "following cessation of exogenous hormonal treatments",
                    "criterion": "cessation of exogenous hormonal treatments",
                    "requirements": [
                        {
                            "requirement_type": "temporal relation",
                            "expected_value": "following"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post-menopausal range for women under 50;",
            "criterions": [
                {
                    "exact_snippets": "Luteinizing hormone (LH) ... levels in the post-menopausal range",
                    "criterion": "Luteinizing hormone (LH) levels",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "post-menopausal"
                        }
                    ]
                },
                {
                    "exact_snippets": "Follicle stimulating hormone (FSH) levels in the post-menopausal range",
                    "criterion": "Follicle stimulating hormone (FSH) levels",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "post-menopausal"
                        }
                    ]
                },
                {
                    "exact_snippets": "women under 50",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* radiation-induced oophorectomy with last menses >1 year ago;",
            "criterions": [
                {
                    "exact_snippets": "radiation-induced oophorectomy",
                    "criterion": "oophorectomy",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "radiation-induced"
                        }
                    ]
                },
                {
                    "exact_snippets": "last menses >1 year ago",
                    "criterion": "last menses",
                    "requirements": [
                        {
                            "requirement_type": "time since last occurrence",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* chemotherapy-induced menopause with >1 year interval since last menses;",
            "criterions": [
                {
                    "exact_snippets": "chemotherapy-induced menopause",
                    "criterion": "menopause",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "chemotherapy-induced"
                        }
                    ]
                },
                {
                    "exact_snippets": ">1 year interval since last menses",
                    "criterion": "interval since last menses",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* surgical sterilisation (bilateral oophorectomy or hysterectomy).",
            "criterions": [
                {
                    "exact_snippets": "surgical sterilisation (bilateral oophorectomy or hysterectomy)",
                    "criterion": "surgical sterilisation",
                    "requirements": [
                        {
                            "requirement_type": "methods",
                            "expected_value": [
                                "bilateral oophorectomy",
                                "hysterectomy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Women Women of childbearing potential and their partners, who are sexually active, must agree to the use of one highly effective forms of contraception and their partners must use a male condom (as described in Appendix D). This should be started from the signing of the informed consent and continue throughout the period of taking study treatment and for at least 1 month after last dose of study drug",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential",
                    "criterion": "women of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sexually active",
                    "criterion": "sexual activity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "agree to the use of one highly effective forms of contraception",
                    "criterion": "use of contraception",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "partners must use a male condom",
                    "criterion": "use of male condom",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:",
            "criterions": [
                {
                    "exact_snippets": "Patients must have normal organ and bone marrow function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "functionality",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients must have normal organ and bone marrow function",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "functionality",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "measured within 28 days prior to administration of study treatment",
                    "criterion": "measurement timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 28 days prior to administration of study treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Haemoglobin ≥ 10.0 g/dL with no blood transfusion in the past 28 days; Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; Platelet count ≥ 100 x 109/L; Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be ≤ 5x ULN",
            "criterions": [
                {
                    "exact_snippets": "Haemoglobin ≥ 10.0 g/dL",
                    "criterion": "haemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no blood transfusion in the past 28 days",
                    "criterion": "blood transfusion",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) ≥ 1.5 x 109/L",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 109/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelet count ≥ 100 x 109/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 109/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x institutional upper limit of normal (ULN)"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Aspartate aminotransferase (AST) ... / Alanine aminotransferase (ALT) ... ≤ 2.5 x institutional upper limit of normal",
                    "criterion": "AST/ALT levels",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x institutional upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unless liver metastases are present ... ≤ 5x ULN",
                    "criterion": "AST/ALT levels with liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Patients must have creatinine clearance estimated of ≥51 mL/min using the Cockcroft-Gault equation or based on a 24-hour urine test:",
            "criterions": [
                {
                    "exact_snippets": "creatinine clearance estimated of ≥51 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "estimation method",
                            "expected_value": [
                                "Cockcroft-Gault equation",
                                "24-hour urine test"
                            ]
                        },
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 51,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Estimated creatinine clearance = (140-age [years]) x weight (kg) (x F) a",
            "criterions": [
                {
                    "exact_snippets": "Estimated creatinine clearance = (140-age [years]) x weight (kg) (x F)",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "calculation",
                            "expected_value": "(140-age [years]) x weight (kg) (x F)"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* serum creatinine (mg/dL) x 72 a where F=0.85 for females",
            "criterions": [
                {
                    "exact_snippets": "serum creatinine (mg/dL)",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "unit",
                            "expected_value": "mg/dL"
                        }
                    ]
                },
                {
                    "exact_snippets": "F=0.85 for females",
                    "criterion": "F value for females",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.",
            "criterions": [
                {
                    "exact_snippets": "Willingness and ability to comply with scheduled visits",
                    "criterion": "compliance with scheduled visits",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willingness and ability to comply with ... treatment plan",
                    "criterion": "compliance with treatment plan",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willingness and ability to comply with ... laboratory tests",
                    "criterion": "compliance with laboratory tests",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willingness and ability to comply with ... other trial procedures",
                    "criterion": "compliance with other trial procedures",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "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 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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Patients have received Bevacizumab in concomitance with first line platinum-based therapy.",
            "criterions": [
                {
                    "exact_snippets": "Patients have received Bevacizumab",
                    "criterion": "Bevacizumab treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "first line platinum-based therapy",
                    "criterion": "platinum-based therapy",
                    "requirements": [
                        {
                            "requirement_type": "line of therapy",
                            "expected_value": "first line"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Clear cell, mucinous and mixed mullerian tumors/carcinosarcoma, non-epithelial tumors or ovarian tumors with low malignant potential (ie. borderline tumors) are not allowed.",
            "criterions": [
                {
                    "exact_snippets": "Clear cell, mucinous and mixed mullerian tumors/carcinosarcoma ... are not allowed.",
                    "criterion": "clear cell, mucinous and mixed mullerian tumors/carcinosarcoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "non-epithelial tumors ... are not allowed.",
                    "criterion": "non-epithelial tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "ovarian tumors with low malignant potential (ie. borderline tumors) are not allowed.",
                    "criterion": "ovarian tumors with low malignant potential (ie. borderline tumors)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Received chemotherapy within 14 days to first dose to study drug and / or persistent toxicities (>Common Terminology Criteria for Adverse Event (CTCAE) version 5.0 grade 2) caused by previous cancer therapy, excluding alopecia, peripheral neuropathy and related effects of prior chemotherapy that are unlikely to be exacerbated by treatment with study drug.",
            "criterions": [
                {
                    "exact_snippets": "Received chemotherapy within 14 days to first dose to study drug",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "persistent toxicities (>Common Terminology Criteria for Adverse Event (CTCAE) version 5.0 grade 2) caused by previous cancer therapy",
                    "criterion": "persistent toxicities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "CTCAE grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding alopecia, peripheral neuropathy and related effects of prior chemotherapy that are unlikely to be exacerbated by treatment with study drug",
                    "criterion": "exclusion of specific toxicities",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "alopecia",
                                "peripheral neuropathy",
                                "related effects of prior chemotherapy unlikely to be exacerbated"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. 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": "5. Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable).",
            "criterions": [
                {
                    "exact_snippets": "Whole blood transfusions in the last 120 days prior to entry to the study",
                    "criterion": "whole blood transfusions",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 120,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "packed red blood cells and platelet transfusions are acceptable",
                    "criterion": "packed red blood cells and platelet transfusions",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Breast feeding women.",
            "criterions": [
                {
                    "exact_snippets": "Breast feeding women",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. 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": "8. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection [Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, New York Heart Association (NYHA) grade II or greater congestive heart failure, uncontrolled hypertension, severe peripheral vascular disease, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric illness ]",
            "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": "active"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled ventricular arrhythmia",
                    "criterion": "ventricular arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "recent (within 3 months) myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "New York Heart Association (NYHA) grade II or greater congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "NYHA grade",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "severe peripheral vascular disease",
                    "criterion": "peripheral vascular disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled major seizure disorder",
                    "criterion": "major seizure disorder",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable spinal cord compression",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "superior vena cava syndrome",
                    "criterion": "superior vena cava syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan",
                    "criterion": "interstitial bilateral lung disease",
                    "requirements": [
                        {
                            "requirement_type": "extent",
                            "expected_value": "extensive"
                        },
                        {
                            "requirement_type": "detection method",
                            "expected_value": "High Resolution Computed Tomography (HRCT) scan"
                        }
                    ]
                },
                {
                    "exact_snippets": "any psychiatric illness",
                    "criterion": "psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patients with active second malignancy.",
            "criterions": [
                {
                    "exact_snippets": "Patients with active second malignancy",
                    "criterion": "second malignancy",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Other malignancy unless curatively treated with no evidence of disease for ≥5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma.",
            "criterions": [
                {
                    "exact_snippets": "Other malignancy unless curatively treated with no evidence of disease for ≥5 years",
                    "criterion": "other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "curatively treated"
                        },
                        {
                            "requirement_type": "evidence of disease",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated non-melanoma skin cancer",
                    "criterion": "non-melanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "curatively treated in situ cancer of the cervix",
                    "criterion": "in situ cancer of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "curatively treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "ductal carcinoma in situ (DCIS)",
                    "criterion": "ductal carcinoma in situ (DCIS)",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "curatively treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "Stage 1, grade 1 endometrial carcinoma",
                    "criterion": "endometrial carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "Stage 1"
                        },
                        {
                            "requirement_type": "grade",
                            "expected_value": "grade 1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Any prior treatment for ovarian cancer, other than first line platinum-based therapy, including any maintenance treatment between completion of the platinum regimen and initiation of study drug in this study.",
            "criterions": [
                {
                    "exact_snippets": "Any prior treatment for ovarian cancer, other than first line platinum-based therapy",
                    "criterion": "prior treatment for ovarian cancer",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "other than first line platinum-based therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "including any maintenance treatment between completion of the platinum regimen and initiation of study drug",
                    "criterion": "maintenance treatment",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "between completion of the platinum regimen and initiation of study drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.",
            "criterions": [
                {
                    "exact_snippets": "Major surgery within 2 weeks of starting study treatment",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "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": "status",
                            "expected_value": "recovered"
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Concurrent treatment with other investigational agents.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent treatment with other investigational agents.",
                    "criterion": "concurrent treatment with investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. 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 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",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Any positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus, eg. Hepatitis B surface antigen (HBsAg, Australia antigen) positive, or Hepatitis C antibody (anti-HCV) positive (except if HCV-RNA negative).",
            "criterions": [
                {
                    "exact_snippets": "Any positive test result for hepatitis B virus",
                    "criterion": "hepatitis B virus",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Any positive test result for ... hepatitis C virus",
                    "criterion": "hepatitis C virus",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatitis B surface antigen (HBsAg, Australia antigen) positive",
                    "criterion": "Hepatitis B surface antigen (HBsAg, Australia antigen)",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatitis C antibody (anti-HCV) positive",
                    "criterion": "Hepatitis C antibody (anti-HCV)",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "HCV-RNA negative",
                    "criterion": "HCV-RNA",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. 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": "17. Patients with symptomatic uncontrolled brain metastases. A TC/RMN scan of brain is required at baseline. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment.",
            "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
                        }
                    ]
                },
                {
                    "exact_snippets": "A TC/RMN scan of brain is required at baseline",
                    "criterion": "brain scan",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": "TC/RMN scan at baseline"
                        }
                    ]
                },
                {
                    "exact_snippets": "The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment",
                    "criterion": "corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "dose stability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "start time",
                            "expected_value": "at least 4 weeks prior to treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.",
            "criterions": [
                {
                    "exact_snippets": "spinal cord compression",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "definitive treatment received"
                        },
                        {
                            "requirement_type": "disease stability",
                            "expected_value": "clinically stable for 28 days"
                        }
                    ]
                }
            ]
        },
        {
            "line": "19. Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (eg., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation < 470 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome.",
            "criterions": [
                {
                    "exact_snippets": "Resting ECG indicating uncontrolled, potentially reversible cardiac conditions",
                    "criterion": "uncontrolled, potentially reversible cardiac conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable ischemia",
                    "criterion": "unstable ischemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled symptomatic arrhythmia",
                    "criterion": "uncontrolled symptomatic arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "QTcF prolongation < 470 ms",
                    "criterion": "QTcF prolongation",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 470,
                                "unit": "ms"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "electrolyte disturbances",
                    "criterion": "electrolyte disturbances",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "congenital long QT syndrome",
                    "criterion": "congenital long QT syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "20. Evidence of any other medical conditions, physical examination or laboratory findings that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment related complications;",
            "criterions": [
                {
                    "exact_snippets": "Evidence of any other medical conditions",
                    "criterion": "other medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "physical examination ... that may interfere with the planned treatment",
                    "criterion": "physical examination findings",
                    "requirements": [
                        {
                            "requirement_type": "interference with treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "laboratory findings that may interfere with the planned treatment",
                    "criterion": "laboratory findings",
                    "requirements": [
                        {
                            "requirement_type": "interference with treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "physical examination ... that may ... affect patient compliance",
                    "criterion": "physical examination findings",
                    "requirements": [
                        {
                            "requirement_type": "affect patient compliance",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "laboratory findings that may ... affect patient compliance",
                    "criterion": "laboratory findings",
                    "requirements": [
                        {
                            "requirement_type": "affect patient compliance",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "physical examination ... that may ... place the patient at high risk from treatment related complications",
                    "criterion": "physical examination findings",
                    "requirements": [
                        {
                            "requirement_type": "risk from treatment complications",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "laboratory findings that may ... place the patient at high risk from treatment related complications",
                    "criterion": "laboratory findings",
                    "requirements": [
                        {
                            "requirement_type": "risk from treatment complications",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "21. Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir)",
                    "criterion": "concomitant use of strong CYP3A inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Concomitant use of ... moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil)",
                    "criterion": "concomitant use of moderate CYP3A inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "The required washout period prior to starting olaparib is 2 weeks.",
                    "criterion": "washout period prior to starting olaparib",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "22. Concomitant use of known strong (e.g. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.",
            "criterions": [
                {
                    "exact_snippets": "Concomitant use of known strong ... CYP3A inducers",
                    "criterion": "concomitant use of strong CYP3A inducers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Concomitant use of known ... moderate CYP3A inducers",
                    "criterion": "concomitant use of moderate CYP3A inducers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital",
                    "criterion": "washout period for enzalutamide or phenobarbital",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 5,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "The required washout period prior to starting olaparib is ... 3 weeks for other agents",
                    "criterion": "washout period for other agents",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "23. 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": "24. Presence of any other condition that may increase the risk associated with study participation or may interfere with the interpretation of study results, and in the opinion of the investigator, would make the",
            "criterions": [
                {
                    "exact_snippets": "Presence of any other condition that may increase the risk associated with study participation",
                    "criterion": "other condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "risk",
                            "expected_value": "increase"
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of any other condition that ... may interfere with the interpretation of study results",
                    "criterion": "other condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "interference",
                            "expected_value": "interpretation of study results"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}