{
    "info": {
        "nct_id": "NCT04042831",
        "official_title": "A Phase II Study of Olaparib in Patients With Advanced Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations",
        "inclusion_criteria": "* Age >= 18 years\n* Histological or cytological documentation of metastatic adenocarcinoma of the biliary tract\n* Patients with previously identified genetic aberrations that are associated with homologous recombinant repair pathway will be eligible [e.g. somatic mutations in ATM, ATR, CHEK2, BRCA 1/2, RAD51, BRIP1, PALB2, PTEN, FANC, NBN, EMSY, MRE11, ARID1A] or germline mutations in the above genes. Clinical Laboratory Improvement Act (CLIA)-certified assays including commercial tests (Foundation Medicine, Caris, Tempus) will be allowed\n* Measurable disease\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2. (Form is available on the Academic and Community Cancer Research United [ACCRU] website)\n* Life expectancy of >= 16 weeks per estimation of investigator\n* Absolute neutrophil count (ANC) >= 1500/mm^3 (obtained =< 7 days prior to registration)\n* Platelet count >= 75,000/mm^3 (obtained =< 7 days prior to registration)\n* Hemoglobin >= 9.0 g/dL with no blood transfusion in the past 28 days (obtained =< 7 days prior to registration)\n* Total bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 7 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer) (obtained =< 7 days prior to registration)\n* Serum creatinine =< 1.5 x ULN (obtained =< 7 days prior to registration)\n* Institutional normalized ratio (INR)/activated partial thromboplastin time (aPTT) =< 1.5 x ULN (obtained =< 7 days prior to registration)\n\n  * Exception: Patients who are therapeutically treated with anticoagulant agents will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of care\n* Alkaline phosphatase limit =< 2.5 x ULN (=< 5 x ULN for patients with liver involvement of their cancer) (obtained =< 7 days prior to registration)\n* Creatinine clearance estimated of >= 51 mL/min using the Cockcroft-Gault equation (obtained =< 7 days prior to registration)\n* Negative serum pregnancy test done =< 28 days prior to registration and confirmed prior to treatment on day 1, for women of childbearing potential, postmenopausal women or women of childbearing potential with evidence of non-childbearing status.\n\n  * Postmenopausal is defined as:\n\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 sterilization (bilateral oophorectomy or hysterectomy)\n* Provide informed written consent\n* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n* Willing to provide blood and tissue for correlative purposes\n* Hepatitis B virus surface antigen (HBsAg), anti-hepatitis B virus core antigen (anti-HBc) and hepatitis B virus surface antigen (anti-HBs)\n* Patients with chronic HBV receiving any systemic anticancer therapy should receive antiviral prophylactic therapy through and for minimum 12 months following anticancer therapy\n* Patients with past HBV undergoing other systemic anticancer therapies not clearly associated with a high risk of HBV reactivation should be monitored with HBsAg and alanine aminotransferase during cancer treatment (suggest every other cycle)\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Platinum refractory disease which was defined as:\n\n  * Evidence disease progression on platinum based chemotherapy regimen or\n  * Evidence of disease progression =< 6 months of completion of platinum based adjuvant chemotherapy regimen\n* Patient has received prior systemic anti-cancer therapy, tumor embolization or radiotherapy =< 28 days prior to registration\n* Major surgical procedure, open biopsy, or significant traumatic injury =< 28 days prior to registration\n\n  * NOTE: Patients must have recovered from any effects of any major surgery\n* Congestive heart failure - New York Heart Association (NYHA) >= class II\n* Resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (eg. unstable ischemia, uncontrolled symptomatic arrhythmia, corrected QT interval by Fridericia's correction formula [QTcF] prolongation > 500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome. Cardiac arrhythmias requiring anti-arrhythmic therapy.\n\n  * NOTE: Pacemaker, beta blockers or digoxin are permitted\n* Uncontrolled hypertension - grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. (despite optimal medical management)\n* History of or current pheochromocytoma\n* Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism =< 6 months prior to registration\n* Ongoing infection > grade 2 National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0\n* Seizure disorder requiring medication\n* Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study =< 28 days of registration and is clinically stable with respect to the tumor at the time of registration. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days prior to registration\n\n  * NOTE: The patient can receive a stable dose of corticosteroids before and during the study as long as these were started =< 28 days prior to registration\n* History of organ allograft (including corneal transplant) or allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)\n* Evidence or history of bleeding diathesis or any hemorrhage or bleeding event > CTCAE v5.0 grade 3, =< 28 days prior to registration\n* Non-healing wound, ulcer, or bone fracture\n* Renal failure requiring hemo-or peritoneal dialysis\n* Dehydration CTCAE v5.0 grade >= 2\n* Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results\n* Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation\n* Interstitial lung disease with ongoing signs and symptoms at the time of informed consent\n* Persistent proteinuria of CTCAE v5.0 grade 3 or higher (>= 3.5 g/24 hours [hrs])\n* Unable to swallow orally administered medications\n* Any malabsorption condition and/or patients with gastrointestinal disorders likely to interfere with absorption of the study medication\n* Unresolved toxicity greater than CTCAE v5.0 grade 2 attributed to any prior therapy/procedure excluding alopecia and oxaliplatin induced neurotoxicity =< grade 2\n* Albumin levels < 2.5 g/dl\n* Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown.\n\n  * Pregnant women\n  * Nursing women\n  * Men or women of childbearing potential who are unwilling to employ adequate contraception\n  * NOTE: Women of childbearing potential and their partners, who are sexually active, must agree to the use of TWO highly effective forms of contraception in combination. This should be started from the time of registration and continue throughout the period of taking study treatment and for at least 1 month after last dose of study drug(s), or they must totally/truly abstain from any form of sexual intercourse.\n  * Male patients must use a condom during treatment and for 3 months after the last dose of olaparib when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential. Male patients should not donate sperm throughout the period of taking olaparib and for 3 months following the last dose of olaparib\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens. 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, 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 disorder that prohibits obtaining informed consent\n* Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) serologically positive and currently receiving antiretroviral therapy.\n\n  * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm\n* Previous and/or intercurrent cancers. With the exception of: curatively-treated cancers with no recurrence in >= 5 years or early cancers treated with curative intent, including but not limited to cervical carcinoma in situ, superficial, noninvasive bladder cancer, basal cell carcinoma, squamous cell carcinoma in situ, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma, or endoscopically resected gastrointestinal cancers limited in mucosal layer\n\n  * NOTE: All cancer treatments for cancers that were distinct in a primary site other than biliary tract cancer must be completed >= 3 years prior to registration\n* Pleural effusion or ascites that causes respiratory compromise (>= CTCAE v5.0 grade 2 dyspnea)\n* Previous enrollment in the present study\n* Prior exposure to any PARP inhibitor including olaparib\n* Known hypersensitivity reaction to olaparib or any of the excipients of the product\n* Myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of myelodysplastic syndrome/acute myeloid leukemia (MDS/AML)\n* Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil).\n\n  * NOTE: The required washout period prior to registration is 2 weeks\n* Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil).\n\n  * NOTE: The required washout period prior to registration is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents\n* Patient taking medications or herbal products including grapefruits, grapefruit hybrids, pomelos, star fruits, Seville oranges, pomegranates, or the juice from any of these. Note: Patients must discontinue the drug/product >= 7 days prior to registration\n* Patient taking medications with a known risk to prolong the QTc interval and/or cause Torsades de Pointes. Note: Patients must be discontinued >= 7 days of registration. Treating physicians may wish to replace the drug(s) that do not carry this risk with safe alternative(s)\n* Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable outside of 28 days prior to treatment)\n* Involvement in the planning and/or conduct of the study\n* 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",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Age >= 18 years",
            "criterions": [
                {
                    "exact_snippets": "Age >= 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histological or cytological documentation of metastatic adenocarcinoma of the biliary tract",
            "criterions": [
                {
                    "exact_snippets": "Histological or cytological documentation",
                    "criterion": "documentation",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "histological",
                                "cytological"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic adenocarcinoma of the biliary tract",
                    "criterion": "adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "biliary tract"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": "metastatic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with previously identified genetic aberrations that are associated with homologous recombinant repair pathway will be eligible [e.g. somatic mutations in ATM, ATR, CHEK2, BRCA 1/2, RAD51, BRIP1, PALB2, PTEN, FANC, NBN, EMSY, MRE11, ARID1A] or germline mutations in the above genes. Clinical Laboratory Improvement Act (CLIA)-certified assays including commercial tests (Foundation Medicine, Caris, Tempus) will be allowed",
            "criterions": [
                {
                    "exact_snippets": "previously identified genetic aberrations ... associated with homologous recombinant repair pathway",
                    "criterion": "genetic aberrations",
                    "requirements": [
                        {
                            "requirement_type": "association",
                            "expected_value": "homologous recombinant repair pathway"
                        }
                    ]
                },
                {
                    "exact_snippets": "somatic mutations in ATM, ATR, CHEK2, BRCA 1/2, RAD51, BRIP1, PALB2, PTEN, FANC, NBN, EMSY, MRE11, ARID1A",
                    "criterion": "somatic mutations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "ATM",
                                "ATR",
                                "CHEK2",
                                "BRCA 1/2",
                                "RAD51",
                                "BRIP1",
                                "PALB2",
                                "PTEN",
                                "FANC",
                                "NBN",
                                "EMSY",
                                "MRE11",
                                "ARID1A"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "germline mutations in the above genes",
                    "criterion": "germline mutations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "ATM",
                                "ATR",
                                "CHEK2",
                                "BRCA 1/2",
                                "RAD51",
                                "BRIP1",
                                "PALB2",
                                "PTEN",
                                "FANC",
                                "NBN",
                                "EMSY",
                                "MRE11",
                                "ARID1A"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinical Laboratory Improvement Act (CLIA)-certified assays including commercial tests (Foundation Medicine, Caris, Tempus)",
                    "criterion": "CLIA-certified assays",
                    "requirements": [
                        {
                            "requirement_type": "certification",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "Foundation Medicine",
                                "Caris",
                                "Tempus"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2. (Form is available on the Academic and Community Cancer Research United [ACCRU] website)",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2.",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of >= 16 weeks per estimation of investigator",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of >= 16 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 16,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count (ANC) >= 1500/mm^3 (obtained =< 7 days prior to registration)",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) >= 1500/mm^3",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count >= 75,000/mm^3 (obtained =< 7 days prior to registration)",
            "criterions": [
                {
                    "exact_snippets": "Platelet count >= 75,000/mm^3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 75000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin >= 9.0 g/dL with no blood transfusion in the past 28 days (obtained =< 7 days prior to registration)",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin >= 9.0 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no blood transfusion in the past 28 days",
                    "criterion": "blood transfusion",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "obtained =< 7 days prior to registration",
                    "criterion": "test timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 7 days prior to registration)",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin =< 1.5 x upper limit of normal (ULN)",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer) (obtained =< 7 days prior to registration)",
            "criterions": [
                {
                    "exact_snippets": "Alanine aminotransferase (ALT) ... =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer)",
                    "criterion": "Alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Alanine aminotransferase (ALT) ... =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer)",
                    "criterion": "Alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate aminotransferase (AST) =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer)",
                    "criterion": "aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate aminotransferase (AST) =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer)",
                    "criterion": "aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "obtained =< 7 days prior to registration",
                    "criterion": "test timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 7,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine =< 1.5 x ULN (obtained =< 7 days prior to registration)",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine =< 1.5 x ULN",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Institutional normalized ratio (INR)/activated partial thromboplastin time (aPTT) =< 1.5 x ULN (obtained =< 7 days prior to registration)",
            "criterions": [
                {
                    "exact_snippets": "Institutional normalized ratio (INR) ... =< 1.5 x ULN",
                    "criterion": "Institutional normalized ratio (INR)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "activated partial thromboplastin time (aPTT) =< 1.5 x ULN",
                    "criterion": "activated partial thromboplastin time (aPTT)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "obtained =< 7 days prior to registration",
                    "criterion": "time of test",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 7,
                                "unit": "days prior to registration"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Exception: Patients who are therapeutically treated with anticoagulant agents will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of care",
            "criterions": [
                {
                    "exact_snippets": "therapeutically treated with anticoagulant agents",
                    "criterion": "anticoagulant treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no prior evidence of underlying abnormality in coagulation parameters",
                    "criterion": "abnormality in coagulation parameters",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "INR/PTT is stable",
                    "criterion": "INR/PTT stability",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Alkaline phosphatase limit =< 2.5 x ULN (=< 5 x ULN for patients with liver involvement of their cancer) (obtained =< 7 days prior to registration)",
            "criterions": [
                {
                    "exact_snippets": "Alkaline phosphatase limit =< 2.5 x ULN",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "limit",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Alkaline phosphatase limit ... (=< 5 x ULN for patients with liver involvement of their cancer)",
                    "criterion": "alkaline phosphatase with liver involvement",
                    "requirements": [
                        {
                            "requirement_type": "limit",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "obtained =< 7 days prior to registration",
                    "criterion": "alkaline phosphatase test timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 7,
                                "unit": "days prior to registration"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine clearance estimated of >= 51 mL/min using the Cockcroft-Gault equation (obtained =< 7 days prior to registration)",
            "criterions": [
                {
                    "exact_snippets": "Creatinine clearance estimated of >= 51 mL/min using the Cockcroft-Gault equation",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "estimation method",
                            "expected_value": "Cockcroft-Gault equation"
                        },
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 51,
                                "unit": "mL/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "obtained =< 7 days prior to registration",
                    "criterion": "timeframe for creatinine clearance measurement",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Negative serum pregnancy test done =< 28 days prior to registration and confirmed prior to treatment on day 1, for women of childbearing potential, postmenopausal women or women of childbearing potential with evidence of non-childbearing status.",
            "criterions": [
                {
                    "exact_snippets": "Negative serum pregnancy test ... for women of childbearing potential",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "Negative serum pregnancy test ... =< 28 days prior to registration",
                    "criterion": "serum pregnancy test timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Negative serum pregnancy test ... confirmed prior to treatment on day 1",
                    "criterion": "serum pregnancy test confirmation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "prior to treatment on day 1"
                        }
                    ]
                },
                {
                    "exact_snippets": "for women of childbearing potential",
                    "criterion": "women of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "postmenopausal women",
                    "criterion": "postmenopausal women",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "women of childbearing potential with evidence of non-childbearing status",
                    "criterion": "women of childbearing potential with evidence of non-childbearing status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Postmenopausal is defined as:",
            "criterions": [
                {
                    "exact_snippets": "Postmenopausal",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "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": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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 sterilization (bilateral oophorectomy or hysterectomy)",
            "criterions": [
                {
                    "exact_snippets": "Surgical sterilization (bilateral oophorectomy or hysterectomy)",
                    "criterion": "surgical sterilization",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": [
                                "bilateral oophorectomy",
                                "hysterectomy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Provide informed written consent",
            "criterions": [
                {
                    "exact_snippets": "Provide informed written consent",
                    "criterion": "informed written consent",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)",
            "criterions": [
                {
                    "exact_snippets": "Willing to return to enrolling institution for follow-up",
                    "criterion": "willingness to return for follow-up",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willing to provide blood and tissue for correlative purposes",
            "criterions": [
                {
                    "exact_snippets": "Willing to provide blood",
                    "criterion": "blood donation",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willing to provide ... tissue for correlative purposes",
                    "criterion": "tissue donation",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hepatitis B virus surface antigen (HBsAg), anti-hepatitis B virus core antigen (anti-HBc) and hepatitis B virus surface antigen (anti-HBs)",
            "criterions": [
                {
                    "exact_snippets": "Hepatitis B virus surface antigen (HBsAg)",
                    "criterion": "Hepatitis B virus surface antigen (HBsAg)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "anti-hepatitis B virus core antigen (anti-HBc)",
                    "criterion": "anti-hepatitis B virus core antigen (anti-HBc)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis B virus surface antigen (anti-HBs)",
                    "criterion": "hepatitis B virus surface antigen (anti-HBs)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with chronic HBV receiving any systemic anticancer therapy should receive antiviral prophylactic therapy through and for minimum 12 months following anticancer therapy",
            "criterions": [
                {
                    "exact_snippets": "Patients with chronic HBV",
                    "criterion": "chronic HBV",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "receiving any systemic anticancer therapy",
                    "criterion": "systemic anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with past HBV undergoing other systemic anticancer therapies not clearly associated with a high risk of HBV reactivation should be monitored with HBsAg and alanine aminotransferase during cancer treatment (suggest every other cycle)",
            "criterions": [
                {
                    "exact_snippets": "past HBV",
                    "criterion": "past HBV",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other systemic anticancer therapies not clearly associated with a high risk of HBV reactivation",
                    "criterion": "systemic anticancer therapies",
                    "requirements": [
                        {
                            "requirement_type": "risk of HBV reactivation",
                            "expected_value": "not clearly associated with high risk"
                        }
                    ]
                },
                {
                    "exact_snippets": "monitored with HBsAg",
                    "criterion": "HBsAg monitoring",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": "during cancer treatment (suggest every other cycle)"
                        }
                    ]
                },
                {
                    "exact_snippets": "monitored with ... alanine aminotransferase",
                    "criterion": "alanine aminotransferase monitoring",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": "during cancer treatment (suggest every other cycle)"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Platinum refractory disease which was defined as:",
            "criterions": [
                {
                    "exact_snippets": "Platinum refractory disease",
                    "criterion": "platinum refractory disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence disease progression on platinum based chemotherapy regimen or",
            "criterions": [
                {
                    "exact_snippets": "Evidence disease progression on platinum based chemotherapy regimen",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "platinum based chemotherapy regimen"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of disease progression =< 6 months of completion of platinum based adjuvant chemotherapy regimen",
            "criterions": [
                {
                    "exact_snippets": "Evidence of disease progression =< 6 months of completion of platinum based adjuvant chemotherapy regimen",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "time since completion of platinum based adjuvant chemotherapy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has received prior systemic anti-cancer therapy, tumor embolization or radiotherapy =< 28 days prior to registration",
            "criterions": [
                {
                    "exact_snippets": "Patient has received prior systemic anti-cancer therapy",
                    "criterion": "prior systemic anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor embolization",
                    "criterion": "tumor embolization",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major surgical procedure, open biopsy, or significant traumatic injury =< 28 days prior to registration",
            "criterions": [
                {
                    "exact_snippets": "Major surgical procedure, open biopsy, or significant traumatic injury =< 28 days prior to registration",
                    "criterion": "time since major surgical procedure, open biopsy, or significant traumatic injury",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* NOTE: Patients must have recovered from any effects of any major surgery",
            "criterions": [
                {
                    "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": "* Congestive heart failure - New York Heart Association (NYHA) >= class II",
            "criterions": [
                {
                    "exact_snippets": "Congestive heart failure - New York Heart Association (NYHA) >= class II",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "class"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (eg. unstable ischemia, uncontrolled symptomatic arrhythmia, corrected QT interval by Fridericia's correction formula [QTcF] prolongation > 500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome. Cardiac arrhythmias requiring anti-arrhythmic therapy.",
            "criterions": [
                {
                    "exact_snippets": "Resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions",
                    "criterion": "uncontrolled, potentially reversible cardiac conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Resting electrocardiogram (ECG) ... corrected QT interval by Fridericia's correction formula [QTcF] prolongation > 500 ms",
                    "criterion": "QTcF prolongation",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 500,
                                "unit": "ms"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Resting electrocardiogram (ECG) ... patients with congenital long QT syndrome",
                    "criterion": "congenital long QT syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Cardiac arrhythmias requiring anti-arrhythmic therapy",
                    "criterion": "cardiac arrhythmias requiring anti-arrhythmic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* NOTE: Pacemaker, beta blockers or digoxin are permitted",
            "criterions": [
                {
                    "exact_snippets": "Pacemaker ... are permitted",
                    "criterion": "pacemaker",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "beta blockers ... are permitted",
                    "criterion": "beta blockers",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "digoxin are permitted",
                    "criterion": "digoxin",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled hypertension - grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. (despite optimal medical management)",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled hypertension - grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "CTCAE v5.0"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of or current pheochromocytoma",
            "criterions": [
                {
                    "exact_snippets": "History of or current pheochromocytoma",
                    "criterion": "pheochromocytoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism =< 6 months prior to registration",
            "criterions": [
                {
                    "exact_snippets": "Arterial or venous thrombotic or embolic events ... =< 6 months prior to registration",
                    "criterion": "thrombotic or embolic events",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ongoing infection > grade 2 National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0",
            "criterions": [
                {
                    "exact_snippets": "Ongoing infection > grade 2 National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0",
                    "criterion": "ongoing infection",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "grade (NCI-CTCAE v5.0)"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Seizure disorder requiring medication",
            "criterions": [
                {
                    "exact_snippets": "Seizure disorder requiring medication",
                    "criterion": "seizure disorder",
                    "requirements": [
                        {
                            "requirement_type": "medication requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study =< 28 days of registration and is clinically stable with respect to the tumor at the time of registration. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days prior to registration",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic metastatic brain or meningeal tumors",
                    "criterion": "metastatic brain or meningeal tumors",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unless the patient is > 6 months from definitive therapy",
                    "criterion": "time from definitive therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since therapy",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "has a negative imaging study =< 28 days of registration",
                    "criterion": "imaging study",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "time since imaging",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "is clinically stable with respect to the tumor at the time of registration",
                    "criterion": "clinical stability with respect to the tumor",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with spinal cord compression",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unless considered to have received definitive treatment for this",
                    "criterion": "definitive treatment for spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "treatment received",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of clinically stable disease for 28 days prior to registration",
                    "criterion": "clinical stability of disease",
                    "requirements": [
                        {
                            "requirement_type": "stability duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* NOTE: The patient can receive a stable dose of corticosteroids before and during the study as long as these were started =< 28 days prior to registration",
            "criterions": [
                {
                    "exact_snippets": "The patient can receive a stable dose of corticosteroids ... as long as these were started =< 28 days prior to registration",
                    "criterion": "corticosteroid use",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "stable dose"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days prior to registration"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of organ allograft (including corneal transplant) or allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)",
            "criterions": [
                {
                    "exact_snippets": "History of organ allograft (including corneal transplant)",
                    "criterion": "organ allograft",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "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": "* Evidence or history of bleeding diathesis or any hemorrhage or bleeding event > CTCAE v5.0 grade 3, =< 28 days prior to registration",
            "criterions": [
                {
                    "exact_snippets": "Evidence or history of bleeding diathesis",
                    "criterion": "bleeding diathesis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any hemorrhage or bleeding event > CTCAE v5.0 grade 3, =< 28 days prior to registration",
                    "criterion": "hemorrhage or bleeding event",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "CTCAE v5.0 grade"
                            }
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days prior to registration"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Non-healing wound, ulcer, or bone fracture",
            "criterions": [
                {
                    "exact_snippets": "Non-healing wound",
                    "criterion": "wound",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "non-healing"
                        }
                    ]
                },
                {
                    "exact_snippets": "ulcer",
                    "criterion": "ulcer",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "non-healing"
                        }
                    ]
                },
                {
                    "exact_snippets": "bone fracture",
                    "criterion": "bone fracture",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "non-healing"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Renal failure requiring hemo-or peritoneal dialysis",
            "criterions": [
                {
                    "exact_snippets": "Renal failure requiring hemo-or peritoneal dialysis",
                    "criterion": "renal failure",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "hemodialysis",
                                "peritoneal dialysis"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Dehydration CTCAE v5.0 grade >= 2",
            "criterions": [
                {
                    "exact_snippets": "Dehydration CTCAE v5.0 grade >= 2",
                    "criterion": "dehydration",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "CTCAE v5.0 grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results",
            "criterions": [
                {
                    "exact_snippets": "Substance abuse",
                    "criterion": "substance abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "medical ... conditions that may interfere with the patient's participation in the study or evaluation of the study results",
                    "criterion": "medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "interference with study participation or evaluation",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "psychological ... conditions that may interfere with the patient's participation in the study or evaluation of the study results",
                    "criterion": "psychological conditions",
                    "requirements": [
                        {
                            "requirement_type": "interference with study participation or evaluation",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "social conditions that may interfere with the patient's participation in the study or evaluation of the study results",
                    "criterion": "social conditions",
                    "requirements": [
                        {
                            "requirement_type": "interference with study participation or evaluation",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity to any of the study drugs",
                    "criterion": "hypersensitivity to study drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... study drug classes",
                    "criterion": "hypersensitivity to study drug classes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... excipients in the formulation",
                    "criterion": "hypersensitivity to excipients in the formulation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Interstitial lung disease with ongoing signs and symptoms at the time of informed consent",
            "criterions": [
                {
                    "exact_snippets": "Interstitial lung disease with ongoing signs and symptoms",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "ongoing"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Persistent proteinuria of CTCAE v5.0 grade 3 or higher (>= 3.5 g/24 hours [hrs])",
            "criterions": [
                {
                    "exact_snippets": "Persistent proteinuria of CTCAE v5.0 grade 3 or higher (>= 3.5 g/24 hours [hrs])",
                    "criterion": "proteinuria",
                    "requirements": [
                        {
                            "requirement_type": "persistence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "CTCAE v5.0 grade"
                            }
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3.5,
                                "unit": "g/24 hours"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unable to swallow orally administered medications",
            "criterions": [
                {
                    "exact_snippets": "Unable to swallow orally administered medications",
                    "criterion": "ability to swallow orally administered medications",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any malabsorption condition and/or patients with gastrointestinal disorders likely to interfere with absorption of the study medication",
            "criterions": [
                {
                    "exact_snippets": "Any malabsorption condition",
                    "criterion": "malabsorption condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "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": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unresolved toxicity greater than CTCAE v5.0 grade 2 attributed to any prior therapy/procedure excluding alopecia and oxaliplatin induced neurotoxicity =< grade 2",
            "criterions": [
                {
                    "exact_snippets": "Unresolved toxicity greater than CTCAE v5.0 grade 2 attributed to any prior therapy/procedure",
                    "criterion": "unresolved toxicity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "CTCAE v5.0 grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding alopecia",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding ... oxaliplatin induced neurotoxicity =< grade 2",
                    "criterion": "oxaliplatin induced neurotoxicity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Albumin levels < 2.5 g/dl",
            "criterions": [
                {
                    "exact_snippets": "Albumin levels < 2.5 g/dl",
                    "criterion": "albumin levels",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "g/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown.",
            "criterions": [
                {
                    "exact_snippets": "genotoxic",
                    "criterion": "genotoxic effects",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "mutagenic",
                    "criterion": "mutagenic effects",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "teratogenic",
                    "criterion": "teratogenic effects",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant women",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Nursing women",
            "criterions": [
                {
                    "exact_snippets": "Nursing women",
                    "criterion": "nursing status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Men or women of childbearing potential who are unwilling to employ adequate contraception",
            "criterions": [
                {
                    "exact_snippets": "Men or women of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unwilling to employ adequate contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* NOTE: Women of childbearing potential and their partners, who are sexually active, must agree to the use of TWO highly effective forms of contraception in combination. This should be started from the time of registration and continue throughout the period of taking study treatment and for at least 1 month after last dose of study drug(s), or they must totally/truly abstain from any form of sexual intercourse.",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential",
                    "criterion": "women of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "use of TWO highly effective forms of contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "forms"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "must totally/truly abstain from any form of sexual intercourse",
                    "criterion": "sexual abstinence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Male patients must use a condom during treatment and for 3 months after the last dose of olaparib when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential. Male patients should not donate sperm throughout the period of taking olaparib and for 3 months following the last dose of olaparib",
            "criterions": [
                {
                    "exact_snippets": "Male patients must use a condom during treatment and for 3 months after the last dose of olaparib when having sexual intercourse with a pregnant woman or with a woman of childbearing potential.",
                    "criterion": "male patients condom use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during treatment and for 3 months after the last dose of olaparib"
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "when having sexual intercourse with a pregnant woman or with a woman of childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential.",
                    "criterion": "female partners contraception",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "if they are of childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "Male patients should not donate sperm throughout the period of taking olaparib and for 3 months following the last dose of olaparib",
                    "criterion": "male patients sperm donation",
                    "requirements": [
                        {
                            "requirement_type": "prohibition",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": "throughout the period of taking olaparib and for 3 months following the last dose of olaparib"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens. 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, 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 disorder that prohibits obtaining informed consent",
            "criterions": [
                {
                    "exact_snippets": "Co-morbid systemic illnesses or other severe concurrent disease",
                    "criterion": "co-morbid systemic illnesses",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "severe concurrent disease",
                    "criterion": "severe concurrent disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "serious, uncontrolled medical disorder",
                    "criterion": "serious, uncontrolled medical disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "non-malignant systemic disease",
                    "criterion": "non-malignant systemic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "active, uncontrolled infection",
                    "criterion": "active, uncontrolled infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled ventricular arrhythmia",
                    "criterion": "uncontrolled ventricular arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "recent (within 3 months) myocardial infarction",
                    "criterion": "recent myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled major seizure disorder",
                    "criterion": "uncontrolled major seizure disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable spinal cord compression",
                    "criterion": "unstable spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "superior vena cava syndrome",
                    "criterion": "superior vena cava syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan",
                    "criterion": "extensive interstitial bilateral lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any psychiatric disorder that prohibits obtaining informed consent",
                    "criterion": "psychiatric disorder prohibiting informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) serologically positive and currently receiving antiretroviral therapy.",
            "criterions": [
                {
                    "exact_snippets": "Immunocompromised patients",
                    "criterion": "immunocompromised status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients known to be human immunodeficiency virus (HIV) serologically positive",
                    "criterion": "HIV serological status",
                    "requirements": [
                        {
                            "requirement_type": "serological status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "currently receiving antiretroviral therapy",
                    "criterion": "antiretroviral therapy",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "receiving"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial",
            "criterions": [
                {
                    "exact_snippets": "Patients known to be HIV positive",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "without clinical evidence of an immunocompromised state",
                    "criterion": "immunocompromised state",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm",
            "criterions": [
                {
                    "exact_snippets": "Receiving any other investigational agent ... treatment for the primary neoplasm",
                    "criterion": "investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "purpose",
                            "expected_value": "treatment for the primary neoplasm"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous and/or intercurrent cancers. With the exception of: curatively-treated cancers with no recurrence in >= 5 years or early cancers treated with curative intent, including but not limited to cervical carcinoma in situ, superficial, noninvasive bladder cancer, basal cell carcinoma, squamous cell carcinoma in situ, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma, or endoscopically resected gastrointestinal cancers limited in mucosal layer",
            "criterions": [
                {
                    "exact_snippets": "Previous and/or intercurrent cancers",
                    "criterion": "previous and/or intercurrent cancers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "curatively-treated cancers with no recurrence in >= 5 years",
                    "criterion": "curatively-treated cancers",
                    "requirements": [
                        {
                            "requirement_type": "recurrence",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "early cancers treated with curative intent",
                    "criterion": "early cancers",
                    "requirements": [
                        {
                            "requirement_type": "treatment intent",
                            "expected_value": "curative"
                        }
                    ]
                },
                {
                    "exact_snippets": "cervical carcinoma in situ",
                    "criterion": "cervical carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "treatment intent",
                            "expected_value": "curative"
                        }
                    ]
                },
                {
                    "exact_snippets": "superficial, noninvasive bladder cancer",
                    "criterion": "superficial, noninvasive bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment intent",
                            "expected_value": "curative"
                        }
                    ]
                },
                {
                    "exact_snippets": "basal cell carcinoma",
                    "criterion": "basal cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "treatment intent",
                            "expected_value": "curative"
                        }
                    ]
                },
                {
                    "exact_snippets": "squamous cell carcinoma in situ",
                    "criterion": "squamous cell carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "treatment intent",
                            "expected_value": "curative"
                        }
                    ]
                },
                {
                    "exact_snippets": "ductal carcinoma in situ (DCIS)",
                    "criterion": "ductal carcinoma in situ (DCIS)",
                    "requirements": [
                        {
                            "requirement_type": "treatment intent",
                            "expected_value": "curative"
                        }
                    ]
                },
                {
                    "exact_snippets": "Stage 1, grade 1 endometrial carcinoma",
                    "criterion": "Stage 1, grade 1 endometrial carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "treatment intent",
                            "expected_value": "curative"
                        }
                    ]
                },
                {
                    "exact_snippets": "endoscopically resected gastrointestinal cancers limited in mucosal layer",
                    "criterion": "endoscopically resected gastrointestinal cancers",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "mucosal layer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* NOTE: All cancer treatments for cancers that were distinct in a primary site other than biliary tract cancer must be completed >= 3 years prior to registration",
            "criterions": [
                {
                    "exact_snippets": "cancer treatments for cancers that were distinct in a primary site other than biliary tract cancer",
                    "criterion": "cancer treatments for non-biliary tract cancers",
                    "requirements": [
                        {
                            "requirement_type": "completion time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pleural effusion or ascites that causes respiratory compromise (>= CTCAE v5.0 grade 2 dyspnea)",
            "criterions": [
                {
                    "exact_snippets": "Pleural effusion",
                    "criterion": "pleural effusion",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "causes respiratory compromise (>= CTCAE v5.0 grade 2 dyspnea)"
                        }
                    ]
                },
                {
                    "exact_snippets": "ascites",
                    "criterion": "ascites",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "causes respiratory compromise (>= CTCAE v5.0 grade 2 dyspnea)"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous enrollment in the present study",
            "criterions": [
                {
                    "exact_snippets": "Previous enrollment in the present study",
                    "criterion": "enrollment in the present study",
                    "requirements": [
                        {
                            "requirement_type": "previous",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior exposure to any PARP inhibitor including olaparib",
            "criterions": [
                {
                    "exact_snippets": "Prior exposure to any PARP inhibitor",
                    "criterion": "PARP inhibitor exposure",
                    "requirements": [
                        {
                            "requirement_type": "prior exposure",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "including olaparib",
                    "criterion": "olaparib exposure",
                    "requirements": [
                        {
                            "requirement_type": "prior exposure",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known hypersensitivity reaction to olaparib or any of the excipients of the product",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity reaction to olaparib",
                    "criterion": "hypersensitivity reaction to olaparib",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity reaction to ... any of the excipients of the product",
                    "criterion": "hypersensitivity reaction to excipients of the product",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of myelodysplastic syndrome/acute myeloid leukemia (MDS/AML)",
            "criterions": [
                {
                    "exact_snippets": "Myelodysplastic syndrome/acute myeloid leukemia",
                    "criterion": "myelodysplastic syndrome/acute myeloid leukemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "features suggestive of myelodysplastic syndrome/acute myeloid leukemia (MDS/AML)",
                    "criterion": "features suggestive of myelodysplastic syndrome/acute myeloid leukemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil).",
            "criterions": [
                {
                    "exact_snippets": "Concomitant use of known strong CYP3A inhibitors (eg. 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 (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil)",
                    "criterion": "concomitant use of moderate CYP3A inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* NOTE: The required washout period prior to registration is 2 weeks",
            "criterions": [
                {
                    "exact_snippets": "washout period ... is 2 weeks",
                    "criterion": "washout period",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil).",
            "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 known ... moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil)",
                    "criterion": "concomitant use of moderate CYP3A inducers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* NOTE: The required washout period prior to registration is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents",
            "criterions": [
                {
                    "exact_snippets": "washout period prior to registration is 5 weeks for enzalutamide",
                    "criterion": "washout period for enzalutamide",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 5,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "washout period prior to registration is 5 weeks for ... phenobarbital",
                    "criterion": "washout period for phenobarbital",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 5,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "washout period prior to registration is ... 3 weeks for other agents",
                    "criterion": "washout period for other agents",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient taking medications or herbal products including grapefruits, grapefruit hybrids, pomelos, star fruits, Seville oranges, pomegranates, or the juice from any of these. Note: Patients must discontinue the drug/product >= 7 days prior to registration",
            "criterions": [
                {
                    "exact_snippets": "Patient taking medications or herbal products including grapefruits, grapefruit hybrids, pomelos, star fruits, Seville oranges, pomegranates, or the juice from any of these.",
                    "criterion": "medications or herbal products",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients must discontinue the drug/product >= 7 days prior to registration",
                    "criterion": "discontinuation period",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient taking medications with a known risk to prolong the QTc interval and/or cause Torsades de Pointes. Note: Patients must be discontinued >= 7 days of registration. Treating physicians may wish to replace the drug(s) that do not carry this risk with safe alternative(s)",
            "criterions": [
                {
                    "exact_snippets": "Patient taking medications with a known risk to prolong the QTc interval",
                    "criterion": "medications with a known risk to prolong the QTc interval",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient taking medications ... cause Torsades de Pointes",
                    "criterion": "medications that cause Torsades de Pointes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients must be discontinued >= 7 days of registration",
                    "criterion": "discontinuation of medications",
                    "requirements": [
                        {
                            "requirement_type": "time before registration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable outside of 28 days prior to treatment)",
            "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 since last transfusion",
                            "expected_value": {
                                "operator": ">",
                                "value": 120,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "packed red blood cells and platelet transfusions are acceptable outside of 28 days prior to treatment",
                    "criterion": "packed red blood cells and platelet transfusions",
                    "requirements": [
                        {
                            "requirement_type": "time since last transfusion",
                            "expected_value": {
                                "operator": ">",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Involvement in the planning and/or conduct of the study",
            "criterions": [
                {
                    "exact_snippets": "Involvement in the planning and/or conduct of the study",
                    "criterion": "involvement in study",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": "planning and/or conduct"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 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": "patient is unlikely to comply with study procedures, restrictions and requirements",
                    "criterion": "compliance with study procedures",
                    "requirements": [
                        {
                            "requirement_type": "likelihood",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}