{
    "info": {
        "nct_id": "NCT02788773",
        "official_title": "A Phase II Study of Durvalumab (MEDI4736) With or Without Tremelimumab in Patients With Metastatic Castration Resistant Prostate Cancer",
        "inclusion_criteria": "* Patients must have histologically confirmed adenocarcinoma of the prostate that is castrate resistant.\n* Disease progression as defined as one or both of the following: PSA Progression: A rising PSA with 2 subsequent rises over a reference value (not necessarily consecutively), measured a minimum of one week apart. The PSA that confirms progression must have a value of ≥ 2 ng/ml (ug/L).\n\nOR Objective Progression:\n\n* RECIST 1.1\n* PCWG 3 Criteria for bone progression\n* Patients must be surgically or medically castrated, with testosterone levels of < 50 ng/dL (< 1.7 nM). Patients who have not undergone orchiectomy must continue (or restart if previously discontinued) LHRH therapy throughout the study.\n* All patients must have a tumour block from their primary or metastatic tumour available and consent to release the block/recently cut slides for correlative analyses and the centre/pathologist must have agreed to the submission of the specimen(s). The site of planned biopsy must not be the measurable lesion.\n* Presence of clinically and/or radiologically documented disease. All radiology studies must be performed within 28 days prior to randomization (within 35 days if negative).\n* All patients must have at least one measurable lesion as defined by RECIST 1.1 that has not been the site of the protocol mandated biopsy. The criteria for defining measurable disease are as follows: CT scan (with slice thickness of 5 mm) ≥ 10 mm --> longest diameter; Lymph nodes by CT scan ≥ 15 mm --> measured in short axis\n* Patients must be ≥ 18 years of age.\n* ECOG performance status 0 or 1.\n* Prior Therapy\n\nSystemic Therapy:\n\n0-1 prior regimen of cytotoxic chemotherapy in the CRPC setting is permitted.\n\nHormonal Therapy:\n\n* Patients must be castrate resistant.\n* Have failed/progressed on prior abiraterone and/or enzalutamide.\n* Patients must have discontinued anti-androgens for at least 4 weeks prior to study entry (at least 6 weeks for bicalutamide).\n\nOther therapy:\n\nPrior treatment with other agents, such as tyrosine kinase or other targeted agents is permissible.\n\n* Systemic corticosteroids are permitted at a dose equivalent to ≤10 mg prednisone daily and are only permitted for reasons other than prostate cancer treatment (ex: fatigue, anorexia, etc); topical applications (e.g. rash), inhaled sprays (e.g. obstructive airways diseases), eye drops or local injections (e.g. intra-articular) are permitted.\n* Bisphosphonates/denosumab are permitted for treatment of hypercalcemia, osteoporosis and skeletal-related events.\n\nImmunotherapy:\n\nPatients may not have received prior immune check point inhibitors (anti PDL1 and anti CTL-4). Vaccines and treatment with oncolytic viruses is permissible.\n\nPatients must have recovered from all reversible toxicity related to prior systemic therapy (chemotherapy and hormone) and have adequate washout as follows:\n\nLongest of one of the following:\n\n* Two weeks;\n* The longer of 30 days or 5 half-lives for investigational agents;\n* Standard cycle length of standard therapies.\n\nRadiation:\n\nPrior external beam radiation or radium-223 is permitted provided a minimum of 28 days (4 weeks) have elapsed between the last dose of radiation and the date of randomization. Exceptions may be made for low-dose non-myelosuppressive radiotherapy after consultation with CCTG. Concurrent radiotherapy is not permitted. Prior strontium-89 at any time is not permitted\n\nPrior Surgery:\n\nPrior major surgery is permitted provided that a minimum of 28 days (4 weeks) have elapsed between any major surgery and date of randomization, and that wound healing has occurred.\n\n* Laboratory Requirements (Must be done within 7 days prior to randomization):\n\nAbs Neutrophils ≥ 1.5 x 10^9/L Platelets ≥ 100 x 10^9/L Hemoglobin ≥ 90 g/L Bilirubin ≤ 1.5 x ULN AST and ALT ≤ 2.5 x ULN ≤ 5.0 ULN (if patient has liver mets) Serum Creatinine < 1.25 x ULN or Creatinine clearance ≥ 40mL/min\n\n* Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use male condom plus spermicide while on study and for 6 months after the last dose of durvalumab and tremelimumab, or for 3 months after the last dose of durvalumab alone. Female partners of a male subject must use a highly effective method of contraception throughout this period.\n* Male patients should also refrain from donating sperm during the study and for 6 months after the last dose of durvalumab and tremelimumab or for 3 months after the last dose of durvalumab alone.\n* Subjects should not donate blood while participating in this study, or for at least 90 days following the last infusion of durvalumab or tremelimumab.\n* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate. Patients who cannot give informed consent (i.e. mentally incompetent patients, or those physically incapacitated such as comatose patients) are not to be recruited into the study. Patients competent but physically unable to sign the consent form may have the document signed by their nearest relative or legal guardian. Each patient will be provided with a full explanation of the study before consent is requested.\n* Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 1 ½ hour's driving distance) placed on patients being considered for this trial. The patient's city of residence may be required to verify their geographical proximity. Investigators must assure themselves the patients registered on this trial will be available for complete documentation of the tretment, adverse events, and follow-up.\n* Patients must agree to return to their primary care facility for any adverse events which may occur through the course of the trial.\n* In accordance with CCTG policy, protocol treatment is to begin within 5 working days of patient randomization.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients with a history of other malignancies requiring concurrent anticancer therapy.\n* Patients with brain metastases are not eligible.\n* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease (e.g. colitis or Crohn's disease), diverticulitis with the exception of diverticulosis, celiac disease or other serious gastrointestinal chronic conditions associated with diarrhea), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), rheumatoid arthritis, hypophysitis, uveitis, etc., within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:\n\n  * Patients with alopecia.\n  * Patients with Grave's disease, vitiligo or psoriasis not requiring systemic treatment (within the last 2 years).\n  * Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement.\n* History of primary immunodeficiency, history of allogenic organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of randomization or a prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy or grade ≥ 3 infusion reaction.\n* Live attenuated vaccination administered within 30 days prior to randomization or within 30 days of receiving durvalumab.\n* History of hypersensitivity to durvalumab or tremelimumab or any excipient. Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab or an anti-CTLA4, including tremelimumab.\n* Patients who have experienced untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction within the previous year or cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects). Patients with a significant cardiac history, even if controlled, should have a LVEF ≥ 50%.\n* Concurrent treatment with other investigational drugs or anti-cancer therapy (except LHRH in patients not surgically castrated).\n* Patients with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol (including corticosteroid administration), or would put the patient at risk. This includes but is not limited to:\n\n  * History of significant neurologic or psychiatric disorder which would impair the ability to obtain consent or limit compliance with study requirements.\n  * Active infection requiring systemic therapy; (including any patient known to have active hepatitis B, hepatitis C or human immunodeficiency virus (HIV) or tuberculosis or any infection requiring systemic therapy).\n  * Active peptic ulcer disease or gastritis.\n  * Pneumonitis.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Patients must have histologically confirmed adenocarcinoma of the prostate that is castrate resistant.",
                "criterions": [
                    {
                        "exact_snippets": "histologically confirmed adenocarcinoma of the prostate",
                        "criterion": "adenocarcinoma of the prostate",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    },
                    {
                        "exact_snippets": "castrate resistant",
                        "criterion": "castrate resistance",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "histologically confirmed adenocarcinoma of the prostate",
                        "criterion": "adenocarcinoma of the prostate",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    },
                    {
                        "exact_snippets": "castrate resistant",
                        "criterion": "castrate resistance",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Disease progression as defined as one or both of the following: PSA Progression: A rising PSA with 2 subsequent rises over a reference value (not necessarily consecutively), measured a minimum of one week apart. The PSA that confirms progression must have a value of ≥ 2 ng/ml (ug/L).",
                "criterions": [
                    {
                        "exact_snippets": "Disease progression as defined as one or both of the following: PSA Progression",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "definition",
                            "expected_value": "PSA progression"
                        }
                    },
                    {
                        "exact_snippets": "PSA Progression: A rising PSA with 2 subsequent rises over a reference value (not necessarily consecutively), measured a minimum of one week apart.",
                        "criterion": "PSA progression",
                        "requirement": {
                            "requirement_type": "pattern",
                            "expected_value": "rising PSA with 2 subsequent rises over a reference value, measured a minimum of one week apart"
                        }
                    },
                    {
                        "exact_snippets": "The PSA that confirms progression must have a value of ≥ 2 ng/ml (ug/L).",
                        "criterion": "PSA value",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "ng/ml"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Disease progression as defined as one or both of the following: PSA Progression",
                                "criterion": "disease progression",
                                "requirement": {
                                    "requirement_type": "definition",
                                    "expected_value": "PSA progression"
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "PSA Progression: A rising PSA with 2 subsequent rises over a reference value (not necessarily consecutively), measured a minimum of one week apart.",
                                        "criterion": "PSA progression",
                                        "requirement": {
                                            "requirement_type": "pattern",
                                            "expected_value": "rising PSA with 2 subsequent rises over a reference value, measured a minimum of one week apart"
                                        }
                                    },
                                    {
                                        "exact_snippets": "The PSA that confirms progression must have a value of ≥ 2 ng/ml (ug/L).",
                                        "criterion": "PSA value",
                                        "requirement": {
                                            "requirement_type": "value",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 2,
                                                "unit": "ng/ml"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "OR Objective Progression:",
                "criterions": [
                    {
                        "exact_snippets": "Objective Progression",
                        "criterion": "objective progression",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Objective Progression",
                        "criterion": "objective progression",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* RECIST 1.1",
                "criterions": [
                    {
                        "exact_snippets": "RECIST 1.1",
                        "criterion": "RECIST version",
                        "requirement": {
                            "requirement_type": "version",
                            "expected_value": "1.1"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "RECIST 1.1",
                        "criterion": "RECIST version",
                        "requirement": {
                            "requirement_type": "version",
                            "expected_value": "1.1"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* PCWG 3 Criteria for bone progression",
                "criterions": [
                    {
                        "exact_snippets": "PCWG 3 Criteria for bone progression",
                        "criterion": "bone progression",
                        "requirement": {
                            "requirement_type": "criteria",
                            "expected_value": "PCWG 3"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "PCWG 3 Criteria for bone progression",
                        "criterion": "bone progression",
                        "requirement": {
                            "requirement_type": "criteria",
                            "expected_value": "PCWG 3"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* All patients must have a tumour block from their primary or metastatic tumour available and consent to release the block/recently cut slides for correlative analyses and the centre/pathologist must have agreed to the submission of the specimen(s). The site of planned biopsy must not be the measurable lesion.",
                "criterions": [
                    {
                        "exact_snippets": "tumour block from their primary or metastatic tumour available",
                        "criterion": "tumour block availability",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "consent to release the block/recently cut slides for correlative analyses",
                        "criterion": "consent for release of tumour block/slides",
                        "requirement": {
                            "requirement_type": "consent",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "centre/pathologist must have agreed to the submission of the specimen(s)",
                        "criterion": "agreement from centre/pathologist for specimen submission",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "site of planned biopsy must not be the measurable lesion",
                        "criterion": "site of planned biopsy",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "not the measurable lesion"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "tumour block from their primary or metastatic tumour available",
                                        "criterion": "tumour block availability",
                                        "requirement": {
                                            "requirement_type": "availability",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "consent to release the block/recently cut slides for correlative analyses",
                                        "criterion": "consent for release of tumour block/slides",
                                        "requirement": {
                                            "requirement_type": "consent",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "centre/pathologist must have agreed to the submission of the specimen(s)",
                                "criterion": "agreement from centre/pathologist for specimen submission",
                                "requirement": {
                                    "requirement_type": "agreement",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "site of planned biopsy must not be the measurable lesion",
                            "criterion": "site of planned biopsy",
                            "requirement": {
                                "requirement_type": "location",
                                "expected_value": "not the measurable lesion"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Presence of clinically and/or radiologically documented disease. All radiology studies must be performed within 28 days prior to randomization (within 35 days if negative).",
                "criterions": [
                    {
                        "exact_snippets": "Presence of clinically and/or radiologically documented disease.",
                        "criterion": "documented disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "All radiology studies must be performed within 28 days prior to randomization (within 35 days if negative).",
                        "criterion": "radiology studies timing",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Presence of clinically and/or radiologically documented disease.",
                                "criterion": "documented disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Presence of clinically and/or radiologically documented disease.",
                                        "criterion": "documented disease",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "All radiology studies must be performed within 28 days prior to randomization (within 35 days if negative).",
                                        "criterion": "radiology studies timing",
                                        "requirement": {
                                            "requirement_type": "timing",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": "<=",
                                                        "value": 28,
                                                        "unit": "days"
                                                    }
                                                ]
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "All radiology studies must be performed within 28 days prior to randomization (within 35 days if negative).",
                        "criterion": "radiology studies timing",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* All patients must have at least one measurable lesion as defined by RECIST 1.1 that has not been the site of the protocol mandated biopsy. The criteria for defining measurable disease are as follows: CT scan (with slice thickness of 5 mm) ≥ 10 mm --> longest diameter; Lymph nodes by CT scan ≥ 15 mm --> measured in short axis",
                "criterions": [
                    {
                        "exact_snippets": "at least one measurable lesion",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "lesion ... not been the site of the protocol mandated biopsy",
                        "criterion": "lesion biopsy status",
                        "requirement": {
                            "requirement_type": "biopsy status",
                            "expected_value": "not been the site of the protocol mandated biopsy"
                        }
                    },
                    {
                        "exact_snippets": "CT scan (with slice thickness of 5 mm) ≥ 10 mm --> longest diameter",
                        "criterion": "lesion size on CT scan",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Lymph nodes by CT scan ≥ 15 mm --> measured in short axis",
                        "criterion": "lymph node size on CT scan",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "mm"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "at least one measurable lesion",
                                                "criterion": "measurable lesion",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": true
                                                }
                                            },
                                            {
                                                "exact_snippets": "lesion ... not been the site of the protocol mandated biopsy",
                                                "criterion": "lesion biopsy status",
                                                "requirement": {
                                                    "requirement_type": "biopsy status",
                                                    "expected_value": "not been the site of the protocol mandated biopsy"
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "CT scan (with slice thickness of 5 mm) ≥ 10 mm --> longest diameter",
                                        "criterion": "lesion size on CT scan",
                                        "requirement": {
                                            "requirement_type": "size",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 10,
                                                "unit": "mm"
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "Lymph nodes by CT scan ≥ 15 mm --> measured in short axis",
                                "criterion": "lymph node size on CT scan",
                                "requirement": {
                                    "requirement_type": "size",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 15,
                                        "unit": "mm"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must be ≥ 18 years of age.",
                "criterions": [
                    {
                        "exact_snippets": "Patients must be ≥ 18 years of age.",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients must be ≥ 18 years of age.",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Prior Therapy",
                "criterions": [
                    {
                        "exact_snippets": "Prior Therapy",
                        "criterion": "prior therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Prior Therapy",
                        "criterion": "prior therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Systemic Therapy:",
                "criterions": [
                    {
                        "exact_snippets": "Systemic Therapy",
                        "criterion": "systemic therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Systemic Therapy",
                        "criterion": "systemic therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "0-1 prior regimen of cytotoxic chemotherapy in the CRPC setting is permitted.",
                "criterions": [
                    {
                        "exact_snippets": "0-1 prior regimen of cytotoxic chemotherapy in the CRPC setting",
                        "criterion": "prior regimen of cytotoxic chemotherapy in the CRPC setting",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "0-1 prior regimen of cytotoxic chemotherapy in the CRPC setting",
                        "criterion": "prior regimen of cytotoxic chemotherapy in the CRPC setting",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Hormonal Therapy:",
                "criterions": [
                    {
                        "exact_snippets": "Hormonal Therapy",
                        "criterion": "hormonal therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hormonal Therapy",
                        "criterion": "hormonal therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must be castrate resistant.",
                "criterions": [
                    {
                        "exact_snippets": "Patients must be castrate resistant.",
                        "criterion": "castrate resistance",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients must be castrate resistant.",
                        "criterion": "castrate resistance",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Have failed/progressed on prior abiraterone and/or enzalutamide.",
                "criterions": [
                    {
                        "exact_snippets": "failed/progressed on prior abiraterone",
                        "criterion": "prior abiraterone treatment",
                        "requirement": {
                            "requirement_type": "outcome",
                            "expected_value": [
                                "failed",
                                "progressed"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "failed/progressed on prior ... enzalutamide",
                        "criterion": "prior enzalutamide treatment",
                        "requirement": {
                            "requirement_type": "outcome",
                            "expected_value": [
                                "failed",
                                "progressed"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "failed/progressed on prior abiraterone",
                                "criterion": "prior abiraterone treatment",
                                "requirement": {
                                    "requirement_type": "outcome",
                                    "expected_value": [
                                        "failed",
                                        "progressed"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "failed/progressed on prior ... enzalutamide",
                                "criterion": "prior enzalutamide treatment",
                                "requirement": {
                                    "requirement_type": "outcome",
                                    "expected_value": [
                                        "failed",
                                        "progressed"
                                    ]
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must have discontinued anti-androgens for at least 4 weeks prior to study entry (at least 6 weeks for bicalutamide).",
                "criterions": [
                    {
                        "exact_snippets": "Patients must have discontinued anti-androgens for at least 4 weeks prior to study entry",
                        "criterion": "anti-androgen discontinuation",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "(at least 6 weeks for bicalutamide)",
                        "criterion": "bicalutamide discontinuation",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Patients must have discontinued anti-androgens for at least 4 weeks prior to study entry",
                                "criterion": "anti-androgen discontinuation",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "(at least 6 weeks for bicalutamide)",
                                "criterion": "bicalutamide discontinuation",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 6,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "(at least 6 weeks for bicalutamide)",
                        "criterion": "bicalutamide discontinuation",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Other therapy:",
                "criterions": [
                    {
                        "exact_snippets": "Other therapy",
                        "criterion": "other therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Other therapy",
                        "criterion": "other therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Prior treatment with other agents, such as tyrosine kinase or other targeted agents is permissible.",
                "criterions": [
                    {
                        "exact_snippets": "Prior treatment with other agents, such as tyrosine kinase or other targeted agents is permissible.",
                        "criterion": "prior treatment with targeted agents",
                        "requirement": {
                            "requirement_type": "permissibility",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Prior treatment with other agents, such as tyrosine kinase or other targeted agents is permissible.",
                        "criterion": "prior treatment with targeted agents",
                        "requirement": {
                            "requirement_type": "permissibility",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Systemic corticosteroids are permitted at a dose equivalent to ≤10 mg prednisone daily and are only permitted for reasons other than prostate cancer treatment (ex: fatigue, anorexia, etc); topical applications (e.g. rash), inhaled sprays (e.g. obstructive airways diseases), eye drops or local injections (e.g. intra-articular) are permitted.",
                "criterions": [
                    {
                        "exact_snippets": "Systemic corticosteroids are permitted at a dose equivalent to ≤10 mg prednisone daily",
                        "criterion": "systemic corticosteroids",
                        "requirement": {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "mg prednisone daily"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Systemic corticosteroids are permitted ... only permitted for reasons other than prostate cancer treatment",
                        "criterion": "systemic corticosteroids",
                        "requirement": {
                            "requirement_type": "reason for use",
                            "expected_value": "reasons other than prostate cancer treatment"
                        }
                    },
                    {
                        "exact_snippets": "topical applications (e.g. rash), inhaled sprays (e.g. obstructive airways diseases), eye drops or local injections (e.g. intra-articular) are permitted",
                        "criterion": "corticosteroid application methods",
                        "requirement": {
                            "requirement_type": "permitted methods",
                            "expected_value": [
                                "topical applications",
                                "inhaled sprays",
                                "eye drops",
                                "local injections"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Systemic corticosteroids are permitted at a dose equivalent to ≤10 mg prednisone daily",
                                        "criterion": "systemic corticosteroids",
                                        "requirement": {
                                            "requirement_type": "dose",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 10,
                                                "unit": "mg prednisone daily"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "Systemic corticosteroids are permitted ... only permitted for reasons other than prostate cancer treatment",
                                        "criterion": "systemic corticosteroids",
                                        "requirement": {
                                            "requirement_type": "reason for use",
                                            "expected_value": "reasons other than prostate cancer treatment"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "topical applications (e.g. rash), inhaled sprays (e.g. obstructive airways diseases), eye drops or local injections (e.g. intra-articular) are permitted",
                                "criterion": "corticosteroid application methods",
                                "requirement": {
                                    "requirement_type": "permitted methods",
                                    "expected_value": [
                                        "topical applications",
                                        "inhaled sprays",
                                        "eye drops",
                                        "local injections"
                                    ]
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Bisphosphonates/denosumab are permitted for treatment of hypercalcemia, osteoporosis and skeletal-related events.",
                "criterions": [
                    {
                        "exact_snippets": "Bisphosphonates/denosumab are permitted for treatment of hypercalcemia",
                        "criterion": "hypercalcemia",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "bisphosphonates",
                                "denosumab"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Bisphosphonates/denosumab are permitted for treatment of ... osteoporosis",
                        "criterion": "osteoporosis",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "bisphosphonates",
                                "denosumab"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Bisphosphonates/denosumab are permitted for treatment of ... skeletal-related events",
                        "criterion": "skeletal-related events",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "bisphosphonates",
                                "denosumab"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Bisphosphonates/denosumab are permitted for treatment of hypercalcemia",
                                        "criterion": "hypercalcemia",
                                        "requirement": {
                                            "requirement_type": "treatment",
                                            "expected_value": [
                                                "bisphosphonates",
                                                "denosumab"
                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "Bisphosphonates/denosumab are permitted for treatment of ... osteoporosis",
                                        "criterion": "osteoporosis",
                                        "requirement": {
                                            "requirement_type": "treatment",
                                            "expected_value": [
                                                "bisphosphonates",
                                                "denosumab"
                                            ]
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "Bisphosphonates/denosumab are permitted for treatment of ... skeletal-related events",
                                "criterion": "skeletal-related events",
                                "requirement": {
                                    "requirement_type": "treatment",
                                    "expected_value": [
                                        "bisphosphonates",
                                        "denosumab"
                                    ]
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Immunotherapy:",
                "criterions": [
                    {
                        "exact_snippets": "Immunotherapy",
                        "criterion": "immunotherapy",
                        "requirement": {
                            "requirement_type": "treatment type",
                            "expected_value": "immunotherapy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Immunotherapy",
                        "criterion": "immunotherapy",
                        "requirement": {
                            "requirement_type": "treatment type",
                            "expected_value": "immunotherapy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Patients may not have received prior immune check point inhibitors (anti PDL1 and anti CTL-4). Vaccines and treatment with oncolytic viruses is permissible.",
                "criterions": [
                    {
                        "exact_snippets": "Patients may not have received prior immune check point inhibitors (anti PDL1 and anti CTL-4)",
                        "criterion": "prior immune check point inhibitors",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Vaccines and treatment with oncolytic viruses is permissible",
                        "criterion": "vaccines and treatment with oncolytic viruses",
                        "requirement": {
                            "requirement_type": "permissibility",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "Patients may not have received prior immune check point inhibitors (anti PDL1 and anti CTL-4)",
                            "criterion": "prior immune check point inhibitors",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    },
                    {
                        "exact_snippets": "Vaccines and treatment with oncolytic viruses is permissible",
                        "criterion": "vaccines and treatment with oncolytic viruses",
                        "requirement": {
                            "requirement_type": "permissibility",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Patients must have recovered from all reversible toxicity related to prior systemic therapy (chemotherapy and hormone) and have adequate washout as follows:",
                "criterions": [
                    {
                        "exact_snippets": "recovered from all reversible toxicity related to prior systemic therapy (chemotherapy and hormone)",
                        "criterion": "recovery from reversible toxicity",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "adequate washout",
                        "criterion": "washout period",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "recovered from all reversible toxicity related to prior systemic therapy (chemotherapy and hormone)",
                        "criterion": "recovery from reversible toxicity",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "adequate washout",
                        "criterion": "washout period",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Longest of one of the following:",
                "criterions": [
                    {
                        "exact_snippets": "Longest of one of the following",
                        "criterion": "tumor measurement",
                        "requirement": {
                            "requirement_type": "measurement",
                            "expected_value": "longest"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Longest of one of the following",
                        "criterion": "tumor measurement",
                        "requirement": {
                            "requirement_type": "measurement",
                            "expected_value": "longest"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Two weeks;",
                "criterions": [
                    {
                        "exact_snippets": "Two weeks",
                        "criterion": "time since last treatment",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Two weeks",
                        "criterion": "time since last treatment",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Standard cycle length of standard therapies.",
                "criterions": [
                    {
                        "exact_snippets": "Standard cycle length of standard therapies.",
                        "criterion": "cycle length of standard therapies",
                        "requirement": {
                            "requirement_type": "standard",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Standard cycle length of standard therapies.",
                        "criterion": "cycle length of standard therapies",
                        "requirement": {
                            "requirement_type": "standard",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Radiation:",
                "criterions": [
                    {
                        "exact_snippets": "Radiation",
                        "criterion": "radiation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Radiation",
                        "criterion": "radiation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Prior external beam radiation or radium-223 is permitted provided a minimum of 28 days (4 weeks) have elapsed between the last dose of radiation and the date of randomization. Exceptions may be made for low-dose non-myelosuppressive radiotherapy after consultation with CCTG. Concurrent radiotherapy is not permitted. Prior strontium-89 at any time is not permitted",
                "criterions": [
                    {
                        "exact_snippets": "Prior external beam radiation or radium-223 is permitted provided a minimum of 28 days (4 weeks) have elapsed between the last dose of radiation and the date of randomization.",
                        "criterion": "prior external beam radiation or radium-223",
                        "requirement": {
                            "requirement_type": "elapsed time since last dose",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Exceptions may be made for low-dose non-myelosuppressive radiotherapy after consultation with CCTG.",
                        "criterion": "low-dose non-myelosuppressive radiotherapy",
                        "requirement": {
                            "requirement_type": "consultation with CCTG",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Concurrent radiotherapy is not permitted.",
                        "criterion": "concurrent radiotherapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Prior strontium-89 at any time is not permitted",
                        "criterion": "prior strontium-89",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "Prior external beam radiation or radium-223 is permitted provided a minimum of 28 days (4 weeks) have elapsed between the last dose of radiation and the date of randomization.",
                                        "criterion": "prior external beam radiation or radium-223",
                                        "requirement": {
                                            "requirement_type": "elapsed time since last dose",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 28,
                                                "unit": "days"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "Exceptions may be made for low-dose non-myelosuppressive radiotherapy after consultation with CCTG.",
                                        "criterion": "low-dose non-myelosuppressive radiotherapy",
                                        "requirement": {
                                            "requirement_type": "consultation with CCTG",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "Concurrent radiotherapy is not permitted.",
                                "criterion": "concurrent radiotherapy",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Prior strontium-89 at any time is not permitted",
                        "criterion": "prior strontium-89",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Prior Surgery:",
                "criterions": [
                    {
                        "exact_snippets": "Prior Surgery",
                        "criterion": "prior surgery",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Prior Surgery",
                        "criterion": "prior surgery",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Prior major surgery is permitted provided that a minimum of 28 days (4 weeks) have elapsed between any major surgery and date of randomization, and that wound healing has occurred.",
                "criterions": [
                    {
                        "exact_snippets": "Prior major surgery is permitted",
                        "criterion": "prior major surgery",
                        "requirement": {
                            "requirement_type": "permitted",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "a minimum of 28 days (4 weeks) have elapsed between any major surgery and date of randomization",
                        "criterion": "time elapsed since major surgery",
                        "requirement": {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "wound healing has occurred",
                        "criterion": "wound healing",
                        "requirement": {
                            "requirement_type": "occurrence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Prior major surgery is permitted",
                                "criterion": "prior major surgery",
                                "requirement": {
                                    "requirement_type": "permitted",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "a minimum of 28 days (4 weeks) have elapsed between any major surgery and date of randomization",
                                "criterion": "time elapsed since major surgery",
                                "requirement": {
                                    "requirement_type": "time elapsed",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": ">=",
                                                "value": 28,
                                                "unit": "days"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "wound healing has occurred",
                        "criterion": "wound healing",
                        "requirement": {
                            "requirement_type": "occurrence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Laboratory Requirements (Must be done within 7 days prior to randomization):",
                "criterions": [
                    {
                        "exact_snippets": "Laboratory Requirements",
                        "criterion": "laboratory tests",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days prior to randomization"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Laboratory Requirements",
                        "criterion": "laboratory tests",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days prior to randomization"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Abs Neutrophils ≥ 1.5 x 10^9/L Platelets ≥ 100 x 10^9/L Hemoglobin ≥ 90 g/L Bilirubin ≤ 1.5 x ULN AST and ALT ≤ 2.5 x ULN ≤ 5.0 ULN (if patient has liver mets) Serum Creatinine < 1.25 x ULN or Creatinine clearance ≥ 40mL/min",
                "criterions": [
                    {
                        "exact_snippets": "Abs Neutrophils ≥ 1.5 x 10^9/L",
                        "criterion": "absolute neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Platelets ≥ 100 x 10^9/L",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hemoglobin ≥ 90 g/L",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Bilirubin ≤ 1.5 x ULN",
                        "criterion": "bilirubin level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "AST and ALT ≤ 2.5 x ULN",
                        "criterion": "AST and ALT levels",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "≤ 5.0 ULN (if patient has liver mets)",
                        "criterion": "AST and ALT levels with liver metastases",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5.0,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Serum Creatinine < 1.25 x ULN",
                        "criterion": "serum creatinine level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.25,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Creatinine clearance ≥ 40mL/min",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 40,
                                "unit": "mL/min"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "and_criteria": [
                                                    {
                                                        "and_criteria": [
                                                            {
                                                                "and_criteria": [
                                                                    {
                                                                        "exact_snippets": "Abs Neutrophils ≥ 1.5 x 10^9/L",
                                                                        "criterion": "absolute neutrophil count",
                                                                        "requirement": {
                                                                            "requirement_type": "quantity",
                                                                            "expected_value": {
                                                                                "operator": ">=",
                                                                                "value": 1.5,
                                                                                "unit": "x 10^9/L"
                                                                            }
                                                                        }
                                                                    },
                                                                    {
                                                                        "exact_snippets": "Platelets ≥ 100 x 10^9/L",
                                                                        "criterion": "platelet count",
                                                                        "requirement": {
                                                                            "requirement_type": "quantity",
                                                                            "expected_value": {
                                                                                "operator": ">=",
                                                                                "value": 100,
                                                                                "unit": "x 10^9/L"
                                                                            }
                                                                        }
                                                                    }
                                                                ]
                                                            },
                                                            {
                                                                "exact_snippets": "Hemoglobin ≥ 90 g/L",
                                                                "criterion": "hemoglobin level",
                                                                "requirement": {
                                                                    "requirement_type": "quantity",
                                                                    "expected_value": {
                                                                        "operator": ">=",
                                                                        "value": 90,
                                                                        "unit": "g/L"
                                                                    }
                                                                }
                                                            }
                                                        ]
                                                    },
                                                    {
                                                        "exact_snippets": "Bilirubin ≤ 1.5 x ULN",
                                                        "criterion": "bilirubin level",
                                                        "requirement": {
                                                            "requirement_type": "quantity",
                                                            "expected_value": {
                                                                "operator": "<=",
                                                                "value": 1.5,
                                                                "unit": "x ULN"
                                                            }
                                                        }
                                                    }
                                                ]
                                            },
                                            {
                                                "condition": {
                                                    "exact_snippets": "AST and ALT ≤ 2.5 x ULN",
                                                    "criterion": "AST and ALT levels",
                                                    "requirement": {
                                                        "requirement_type": "quantity",
                                                        "expected_value": {
                                                            "operator": "<=",
                                                            "value": 2.5,
                                                            "unit": "x ULN"
                                                        }
                                                    }
                                                },
                                                "then_criteria": null,
                                                "else_criteria": {
                                                    "exact_snippets": "≤ 5.0 ULN (if patient has liver mets)",
                                                    "criterion": "AST and ALT levels with liver metastases",
                                                    "requirement": {
                                                        "requirement_type": "quantity",
                                                        "expected_value": {
                                                            "operator": "<=",
                                                            "value": 5.0,
                                                            "unit": "ULN"
                                                        }
                                                    }
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "or_criteria": [
                                            {
                                                "exact_snippets": "Serum Creatinine < 1.25 x ULN",
                                                "criterion": "serum creatinine level",
                                                "requirement": {
                                                    "requirement_type": "quantity",
                                                    "expected_value": {
                                                        "operator": "<",
                                                        "value": 1.25,
                                                        "unit": "x ULN"
                                                    }
                                                }
                                            },
                                            {
                                                "exact_snippets": "Creatinine clearance ≥ 40mL/min",
                                                "criterion": "creatinine clearance",
                                                "requirement": {
                                                    "requirement_type": "quantity",
                                                    "expected_value": {
                                                        "operator": ">=",
                                                        "value": 40,
                                                        "unit": "mL/min"
                                                    }
                                                }
                                            }
                                        ]
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Male patients should also refrain from donating sperm during the study and for 6 months after the last dose of durvalumab and tremelimumab or for 3 months after the last dose of durvalumab alone.",
                "criterions": [
                    {
                        "exact_snippets": "Male patients",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    },
                    {
                        "exact_snippets": "refrain from donating sperm during the study and for 6 months after the last dose of durvalumab and tremelimumab",
                        "criterion": "sperm donation",
                        "requirement": {
                            "requirement_type": "restriction_period",
                            "expected_value": "during the study and for 6 months after the last dose of durvalumab and tremelimumab"
                        }
                    },
                    {
                        "exact_snippets": "refrain from donating sperm ... for 3 months after the last dose of durvalumab alone",
                        "criterion": "sperm donation",
                        "requirement": {
                            "requirement_type": "restriction_period",
                            "expected_value": "for 3 months after the last dose of durvalumab alone"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Male patients",
                                "criterion": "gender",
                                "requirement": {
                                    "requirement_type": "expected_value",
                                    "expected_value": "male"
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "refrain from donating sperm during the study and for 6 months after the last dose of durvalumab and tremelimumab",
                                        "criterion": "sperm donation",
                                        "requirement": {
                                            "requirement_type": "restriction_period",
                                            "expected_value": "during the study and for 6 months after the last dose of durvalumab and tremelimumab"
                                        }
                                    },
                                    {
                                        "exact_snippets": "refrain from donating sperm ... for 3 months after the last dose of durvalumab alone",
                                        "criterion": "sperm donation",
                                        "requirement": {
                                            "requirement_type": "restriction_period",
                                            "expected_value": "for 3 months after the last dose of durvalumab alone"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Subjects should not donate blood while participating in this study, or for at least 90 days following the last infusion of durvalumab or tremelimumab.",
                "criterions": [
                    {
                        "exact_snippets": "Subjects should not donate blood while participating in this study",
                        "criterion": "blood donation",
                        "requirement": {
                            "requirement_type": "restriction",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "for at least 90 days following the last infusion of durvalumab or tremelimumab",
                        "criterion": "blood donation",
                        "requirement": {
                            "requirement_type": "restriction",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "for at least 90 days following the last infusion of durvalumab or tremelimumab",
                        "criterion": "blood donation",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Subjects should not donate blood while participating in this study",
                                "criterion": "blood donation",
                                "requirement": {
                                    "requirement_type": "restriction",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "for at least 90 days following the last infusion of durvalumab or tremelimumab",
                                "criterion": "blood donation",
                                "requirement": {
                                    "requirement_type": "restriction",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "for at least 90 days following the last infusion of durvalumab or tremelimumab",
                        "criterion": "blood donation",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must agree to return to their primary care facility for any adverse events which may occur through the course of the trial.",
                "criterions": [
                    {
                        "exact_snippets": "Patients must agree to return to their primary care facility",
                        "criterion": "agreement to return to primary care facility",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients must agree to return to their primary care facility",
                        "criterion": "agreement to return to primary care facility",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* In accordance with CCTG policy, protocol treatment is to begin within 5 working days of patient randomization.",
                "criterions": [
                    {
                        "exact_snippets": "protocol treatment is to begin within 5 working days of patient randomization",
                        "criterion": "protocol treatment initiation",
                        "requirement": {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "working days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "protocol treatment is to begin within 5 working days of patient randomization",
                        "criterion": "protocol treatment initiation",
                        "requirement": {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "working days"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must be MALE",
                "criterions": [
                    {
                        "exact_snippets": "Must be MALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be MALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 1 ½ hour's driving distance) placed on patients being considered for this trial. The patient's city of residence may be required to verify their geographical proximity. Investigators must assure themselves the patients registered on this trial will be available for complete documentation of the tretment, adverse events, and follow-up.",
                "criterions": [
                    {
                        "exact_snippets": "Patients must be accessible for treatment and follow up.",
                        "criterion": "patient accessibility",
                        "requirement": {
                            "requirement_type": "accessibility",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Patients registered on this trial must be treated and followed at the participating centre.",
                        "criterion": "treatment and follow-up location",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "participating centre"
                        }
                    },
                    {
                        "exact_snippets": "reasonable geographical limits (for example: 1 ½ hour's driving distance)",
                        "criterion": "geographical proximity",
                        "requirement": {
                            "requirement_type": "distance",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "hour's driving distance"
                            }
                        }
                    },
                    {
                        "exact_snippets": "The patient's city of residence may be required to verify their geographical proximity.",
                        "criterion": "city of residence",
                        "requirement": {
                            "requirement_type": "verification",
                            "expected_value": "required"
                        }
                    },
                    {
                        "exact_snippets": "Investigators must assure themselves the patients registered on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.",
                        "criterion": "availability for documentation",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Patients must be accessible for treatment and follow up.",
                                "criterion": "patient accessibility",
                                "requirement": {
                                    "requirement_type": "accessibility",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Patients registered on this trial must be treated and followed at the participating centre.",
                                "criterion": "treatment and follow-up location",
                                "requirement": {
                                    "requirement_type": "location",
                                    "expected_value": "participating centre"
                                }
                            },
                            {
                                "exact_snippets": "reasonable geographical limits (for example: 1 ½ hour's driving distance)",
                                "criterion": "geographical proximity",
                                "requirement": {
                                    "requirement_type": "distance",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "hour's driving distance"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "The patient's city of residence may be required to verify their geographical proximity.",
                                "criterion": "city of residence",
                                "requirement": {
                                    "requirement_type": "verification",
                                    "expected_value": "required"
                                }
                            },
                            {
                                "exact_snippets": "Investigators must assure themselves the patients registered on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.",
                                "criterion": "availability for documentation",
                                "requirement": {
                                    "requirement_type": "availability",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Patients with a history of other malignancies requiring concurrent anticancer therapy.",
                "criterions": [
                    {
                        "exact_snippets": "history of other malignancies",
                        "criterion": "history of other malignancies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "requiring concurrent anticancer therapy",
                        "criterion": "concurrent anticancer therapy",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "history of other malignancies",
                        "criterion": "history of other malignancies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "requiring concurrent anticancer therapy",
                        "criterion": "concurrent anticancer therapy",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with brain metastases are not eligible.",
                "criterions": [
                    {
                        "exact_snippets": "Patients with brain metastases are not eligible.",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients with brain metastases are not eligible.",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease (e.g. colitis or Crohn's disease), diverticulitis with the exception of diverticulosis, celiac disease or other serious gastrointestinal chronic conditions associated with diarrhea), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), rheumatoid arthritis, hypophysitis, uveitis, etc., within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:",
                "criterions": [
                    {
                        "exact_snippets": "Active or prior documented autoimmune or inflammatory disorders",
                        "criterion": "autoimmune or inflammatory disorders",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "inflammatory bowel disease (e.g. colitis or Crohn's disease)",
                        "criterion": "inflammatory bowel disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "diverticulitis with the exception of diverticulosis",
                        "criterion": "diverticulitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "celiac disease",
                        "criterion": "celiac disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "serious gastrointestinal chronic conditions associated with diarrhea",
                        "criterion": "serious gastrointestinal chronic conditions associated with diarrhea",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "systemic lupus erythematosus",
                        "criterion": "systemic lupus erythematosus",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Sarcoidosis syndrome",
                        "criterion": "Sarcoidosis syndrome",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Wegener syndrome (granulomatosis with polyangiitis)",
                        "criterion": "Wegener syndrome (granulomatosis with polyangiitis)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "rheumatoid arthritis",
                        "criterion": "rheumatoid arthritis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "hypophysitis",
                        "criterion": "hypophysitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "uveitis",
                        "criterion": "uveitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "within the past 3 years prior to the start of treatment",
                        "criterion": "time since diagnosis or activity of autoimmune or inflammatory disorders",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "Active or prior documented autoimmune or inflammatory disorders",
                                        "criterion": "autoimmune or inflammatory disorders",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "inflammatory bowel disease (e.g. colitis or Crohn's disease)",
                                        "criterion": "inflammatory bowel disease",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "diverticulitis with the exception of diverticulosis",
                                        "criterion": "diverticulitis",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "celiac disease",
                                        "criterion": "celiac disease",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "serious gastrointestinal chronic conditions associated with diarrhea",
                                        "criterion": "serious gastrointestinal chronic conditions associated with diarrhea",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "systemic lupus erythematosus",
                                        "criterion": "systemic lupus erythematosus",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "Sarcoidosis syndrome",
                                        "criterion": "Sarcoidosis syndrome",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "Wegener syndrome (granulomatosis with polyangiitis)",
                                        "criterion": "Wegener syndrome (granulomatosis with polyangiitis)",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "rheumatoid arthritis",
                                        "criterion": "rheumatoid arthritis",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "hypophysitis",
                                        "criterion": "hypophysitis",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "uveitis",
                                        "criterion": "uveitis",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "within the past 3 years prior to the start of treatment",
                                "criterion": "time since diagnosis or activity of autoimmune or inflammatory disorders",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "<=",
                                                "value": 3,
                                                "unit": "years"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with alopecia.",
                "criterions": [
                    {
                        "exact_snippets": "Patients with alopecia",
                        "criterion": "alopecia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Patients with alopecia",
                    "criterion": "alopecia",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Patients with Grave's disease, vitiligo or psoriasis not requiring systemic treatment (within the last 2 years).",
                "criterions": [
                    {
                        "exact_snippets": "Grave's disease",
                        "criterion": "Grave's disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "vitiligo",
                        "criterion": "vitiligo",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "psoriasis",
                        "criterion": "psoriasis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "not requiring systemic treatment",
                        "criterion": "systemic treatment requirement",
                        "requirement": {
                            "requirement_type": "requirement",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "within the last 2 years",
                        "criterion": "time since last systemic treatment",
                        "requirement": {
                            "requirement_type": "time",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Grave's disease",
                                        "criterion": "Grave's disease",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "not requiring systemic treatment",
                                        "criterion": "systemic treatment requirement",
                                        "requirement": {
                                            "requirement_type": "requirement",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "within the last 2 years",
                                        "criterion": "time since last systemic treatment",
                                        "requirement": {
                                            "requirement_type": "time",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": "<=",
                                                        "value": 2,
                                                        "unit": "years"
                                                    }
                                                ]
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "vitiligo",
                                        "criterion": "vitiligo",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "not requiring systemic treatment",
                                        "criterion": "systemic treatment requirement",
                                        "requirement": {
                                            "requirement_type": "requirement",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "within the last 2 years",
                                        "criterion": "time since last systemic treatment",
                                        "requirement": {
                                            "requirement_type": "time",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": "<=",
                                                        "value": 2,
                                                        "unit": "years"
                                                    }
                                                ]
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "psoriasis",
                                        "criterion": "psoriasis",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "not requiring systemic treatment",
                                        "criterion": "systemic treatment requirement",
                                        "requirement": {
                                            "requirement_type": "requirement",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "within the last 2 years",
                                        "criterion": "time since last systemic treatment",
                                        "requirement": {
                                            "requirement_type": "time",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": "<=",
                                                        "value": 2,
                                                        "unit": "years"
                                                    }
                                                ]
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement.",
                "criterions": [
                    {
                        "exact_snippets": "Patients with hypothyroidism",
                        "criterion": "hypothyroidism",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "stable on hormone replacement",
                        "criterion": "hormone replacement",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Patients with hypothyroidism",
                                    "criterion": "hypothyroidism",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "exact_snippets": "stable on hormone replacement",
                                    "criterion": "hormone replacement",
                                    "requirement": {
                                        "requirement_type": "stability",
                                        "expected_value": true
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of primary immunodeficiency, history of allogenic organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of randomization or a prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy or grade ≥ 3 infusion reaction.",
                "criterions": [
                    {
                        "exact_snippets": "History of primary immunodeficiency",
                        "criterion": "primary immunodeficiency",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "history of allogenic organ transplant that requires therapeutic immunosuppression",
                        "criterion": "allogenic organ transplant",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "history of allogenic organ transplant that requires therapeutic immunosuppression",
                        "criterion": "allogenic organ transplant",
                        "requirement": {
                            "requirement_type": "therapeutic immunosuppression",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "use of immunosuppressive agents within 28 days of randomization",
                        "criterion": "use of immunosuppressive agents",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy",
                        "criterion": "immune mediated toxicity from other immune therapy",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy",
                        "criterion": "immune mediated toxicity from other immune therapy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "grade ≥ 3 infusion reaction",
                        "criterion": "infusion reaction",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "grade"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of primary immunodeficiency",
                                "criterion": "primary immunodeficiency",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "history of allogenic organ transplant that requires therapeutic immunosuppression",
                                "criterion": "allogenic organ transplant",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "history of allogenic organ transplant that requires therapeutic immunosuppression",
                                "criterion": "allogenic organ transplant",
                                "requirement": {
                                    "requirement_type": "therapeutic immunosuppression",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "use of immunosuppressive agents within 28 days of randomization",
                                "criterion": "use of immunosuppressive agents",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy",
                                "criterion": "immune mediated toxicity from other immune therapy",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy",
                                "criterion": "immune mediated toxicity from other immune therapy",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "grade"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "grade ≥ 3 infusion reaction",
                                "criterion": "infusion reaction",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "grade"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Live attenuated vaccination administered within 30 days prior to randomization or within 30 days of receiving durvalumab.",
                "criterions": [
                    {
                        "exact_snippets": "Live attenuated vaccination administered within 30 days prior to randomization",
                        "criterion": "live attenuated vaccination",
                        "requirement": {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Live attenuated vaccination administered ... within 30 days of receiving durvalumab",
                        "criterion": "live attenuated vaccination",
                        "requirement": {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Live attenuated vaccination administered within 30 days prior to randomization",
                        "criterion": "live attenuated vaccination",
                        "requirement": {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Live attenuated vaccination administered ... within 30 days of receiving durvalumab",
                        "criterion": "live attenuated vaccination",
                        "requirement": {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of hypersensitivity to durvalumab or tremelimumab or any excipient. Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab or an anti-CTLA4, including tremelimumab.",
                "criterions": [
                    {
                        "exact_snippets": "History of hypersensitivity to durvalumab or tremelimumab or any excipient.",
                        "criterion": "hypersensitivity",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab",
                        "criterion": "previous treatment with PD1 or PD-L1 inhibitor",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Any previous treatment with ... an anti-CTLA4, including tremelimumab.",
                        "criterion": "previous treatment with anti-CTLA4",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "History of hypersensitivity to durvalumab or tremelimumab or any excipient.",
                                "criterion": "hypersensitivity",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab",
                                "criterion": "previous treatment with PD1 or PD-L1 inhibitor",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Any previous treatment with ... an anti-CTLA4, including tremelimumab.",
                        "criterion": "previous treatment with anti-CTLA4",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients who have experienced untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction within the previous year or cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects). Patients with a significant cardiac history, even if controlled, should have a LVEF ≥ 50%.",
                "criterions": [
                    {
                        "exact_snippets": "untreated and/or uncontrolled cardiovascular conditions",
                        "criterion": "cardiovascular conditions",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    },
                    {
                        "exact_snippets": "untreated and/or uncontrolled cardiovascular conditions",
                        "criterion": "cardiovascular conditions",
                        "requirement": {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    },
                    {
                        "exact_snippets": "symptomatic cardiac dysfunction",
                        "criterion": "cardiac dysfunction",
                        "requirement": {
                            "requirement_type": "symptoms",
                            "expected_value": "symptomatic"
                        }
                    },
                    {
                        "exact_snippets": "unstable angina",
                        "criterion": "angina",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    },
                    {
                        "exact_snippets": "congestive heart failure",
                        "criterion": "heart failure",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "congestive"
                        }
                    },
                    {
                        "exact_snippets": "myocardial infarction within the previous year",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    },
                    {
                        "exact_snippets": "cardiac ventricular arrhythmias requiring medication",
                        "criterion": "cardiac ventricular arrhythmias",
                        "requirement": {
                            "requirement_type": "treatment requirement",
                            "expected_value": "medication"
                        }
                    },
                    {
                        "exact_snippets": "history of 2nd or 3rd degree atrioventricular conduction defects",
                        "criterion": "atrioventricular conduction defects",
                        "requirement": {
                            "requirement_type": "degree",
                            "expected_value": [
                                "2nd",
                                "3rd"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "significant cardiac history",
                        "criterion": "cardiac history",
                        "requirement": {
                            "requirement_type": "significance",
                            "expected_value": "significant"
                        }
                    },
                    {
                        "exact_snippets": "LVEF ≥ 50%",
                        "criterion": "LVEF",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "untreated and/or uncontrolled cardiovascular conditions",
                                        "criterion": "cardiovascular conditions",
                                        "requirement": {
                                            "requirement_type": "treatment status",
                                            "expected_value": "untreated"
                                        }
                                    },
                                    {
                                        "exact_snippets": "untreated and/or uncontrolled cardiovascular conditions",
                                        "criterion": "cardiovascular conditions",
                                        "requirement": {
                                            "requirement_type": "control status",
                                            "expected_value": "uncontrolled"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "symptomatic cardiac dysfunction",
                                "criterion": "cardiac dysfunction",
                                "requirement": {
                                    "requirement_type": "symptoms",
                                    "expected_value": "symptomatic"
                                }
                            },
                            {
                                "exact_snippets": "unstable angina",
                                "criterion": "angina",
                                "requirement": {
                                    "requirement_type": "stability",
                                    "expected_value": "unstable"
                                }
                            },
                            {
                                "exact_snippets": "congestive heart failure",
                                "criterion": "heart failure",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": "congestive"
                                }
                            },
                            {
                                "exact_snippets": "myocardial infarction within the previous year",
                                "criterion": "myocardial infarction",
                                "requirement": {
                                    "requirement_type": "time since event",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "year"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "cardiac ventricular arrhythmias requiring medication",
                                "criterion": "cardiac ventricular arrhythmias",
                                "requirement": {
                                    "requirement_type": "treatment requirement",
                                    "expected_value": "medication"
                                }
                            },
                            {
                                "exact_snippets": "history of 2nd or 3rd degree atrioventricular conduction defects",
                                "criterion": "atrioventricular conduction defects",
                                "requirement": {
                                    "requirement_type": "degree",
                                    "expected_value": [
                                        "2nd",
                                        "3rd"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "condition": {
                            "exact_snippets": "significant cardiac history",
                            "criterion": "cardiac history",
                            "requirement": {
                                "requirement_type": "significance",
                                "expected_value": "significant"
                            }
                        },
                        "then_criteria": {
                            "not_criteria": {
                                "exact_snippets": "LVEF ≥ 50%",
                                "criterion": "LVEF",
                                "requirement": {
                                    "requirement_type": "value",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 50,
                                        "unit": "%"
                                    }
                                }
                            }
                        },
                        "else_criteria": null
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Concurrent treatment with other investigational drugs or anti-cancer therapy (except LHRH in patients not surgically castrated).",
                "criterions": [
                    {
                        "exact_snippets": "Concurrent treatment with other investigational drugs",
                        "criterion": "concurrent treatment with investigational drugs",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Concurrent treatment with other ... anti-cancer therapy (except LHRH in patients not surgically castrated)",
                        "criterion": "concurrent treatment with anti-cancer therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Concurrent treatment with other ... anti-cancer therapy (except LHRH in patients not surgically castrated)",
                        "criterion": "concurrent treatment with anti-cancer therapy",
                        "requirement": {
                            "requirement_type": "exception",
                            "expected_value": "LHRH in patients not surgically castrated"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Concurrent treatment with other investigational drugs",
                                "criterion": "concurrent treatment with investigational drugs",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Concurrent treatment with other ... anti-cancer therapy (except LHRH in patients not surgically castrated)",
                                        "criterion": "concurrent treatment with anti-cancer therapy",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "not_criteria": {
                                            "exact_snippets": "Concurrent treatment with other ... anti-cancer therapy (except LHRH in patients not surgically castrated)",
                                            "criterion": "concurrent treatment with anti-cancer therapy",
                                            "requirement": {
                                                "requirement_type": "exception",
                                                "expected_value": "LHRH in patients not surgically castrated"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol (including corticosteroid administration), or would put the patient at risk. This includes but is not limited to:",
                "criterions": [
                    {
                        "exact_snippets": "serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol",
                        "criterion": "serious illnesses or medical conditions",
                        "requirement": {
                            "requirement_type": "management according to protocol",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "serious illnesses or medical conditions ... would put the patient at risk",
                        "criterion": "serious illnesses or medical conditions",
                        "requirement": {
                            "requirement_type": "risk",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol",
                                "criterion": "serious illnesses or medical conditions",
                                "requirement": {
                                    "requirement_type": "management according to protocol",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "serious illnesses or medical conditions ... would put the patient at risk",
                                "criterion": "serious illnesses or medical conditions",
                                "requirement": {
                                    "requirement_type": "risk",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of significant neurologic or psychiatric disorder which would impair the ability to obtain consent or limit compliance with study requirements.",
                "criterions": [
                    {
                        "exact_snippets": "History of significant neurologic ... disorder",
                        "criterion": "neurologic disorder",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    },
                    {
                        "exact_snippets": "History of significant neurologic ... disorder",
                        "criterion": "neurologic disorder",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of significant ... psychiatric disorder",
                        "criterion": "psychiatric disorder",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    },
                    {
                        "exact_snippets": "History of significant ... psychiatric disorder",
                        "criterion": "psychiatric disorder",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "History of significant neurologic ... disorder",
                                        "criterion": "neurologic disorder",
                                        "requirement": {
                                            "requirement_type": "severity",
                                            "expected_value": "significant"
                                        }
                                    },
                                    {
                                        "exact_snippets": "History of significant neurologic ... disorder",
                                        "criterion": "neurologic disorder",
                                        "requirement": {
                                            "requirement_type": "history",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "History of significant neurologic ... disorder",
                                        "criterion": "neurologic disorder",
                                        "requirement": {
                                            "requirement_type": "impairment",
                                            "expected_value": "ability to obtain consent"
                                        }
                                    },
                                    {
                                        "exact_snippets": "History of significant neurologic ... disorder",
                                        "criterion": "neurologic disorder",
                                        "requirement": {
                                            "requirement_type": "impairment",
                                            "expected_value": "limit compliance with study requirements"
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "History of significant ... psychiatric disorder",
                                        "criterion": "psychiatric disorder",
                                        "requirement": {
                                            "requirement_type": "severity",
                                            "expected_value": "significant"
                                        }
                                    },
                                    {
                                        "exact_snippets": "History of significant ... psychiatric disorder",
                                        "criterion": "psychiatric disorder",
                                        "requirement": {
                                            "requirement_type": "history",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "History of significant ... psychiatric disorder",
                                        "criterion": "psychiatric disorder",
                                        "requirement": {
                                            "requirement_type": "impairment",
                                            "expected_value": "ability to obtain consent"
                                        }
                                    },
                                    {
                                        "exact_snippets": "History of significant ... psychiatric disorder",
                                        "criterion": "psychiatric disorder",
                                        "requirement": {
                                            "requirement_type": "impairment",
                                            "expected_value": "limit compliance with study requirements"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Active peptic ulcer disease or gastritis.",
                "criterions": [
                    {
                        "exact_snippets": "Active peptic ulcer disease",
                        "criterion": "peptic ulcer disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "gastritis",
                        "criterion": "gastritis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Active peptic ulcer disease",
                        "criterion": "peptic ulcer disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "gastritis",
                        "criterion": "gastritis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Pneumonitis.",
                "criterions": [
                    {
                        "exact_snippets": "Pneumonitis.",
                        "criterion": "pneumonitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Pneumonitis.",
                    "criterion": "pneumonitis",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Active infection requiring systemic therapy; (including any patient known to have active hepatitis B, hepatitis C or human immunodeficiency virus (HIV) or tuberculosis or any infection requiring systemic therapy).",
                "criterions": [
                    {
                        "exact_snippets": "Active infection requiring systemic therapy",
                        "criterion": "active infection",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "systemic therapy"
                        }
                    },
                    {
                        "exact_snippets": "active hepatitis B",
                        "criterion": "hepatitis B",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "active hepatitis C",
                        "criterion": "hepatitis C",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "active ... human immunodeficiency virus (HIV)",
                        "criterion": "HIV",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "active ... tuberculosis",
                        "criterion": "tuberculosis",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "any infection requiring systemic therapy",
                        "criterion": "infection",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "systemic therapy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Active infection requiring systemic therapy",
                                "criterion": "active infection",
                                "requirement": {
                                    "requirement_type": "treatment",
                                    "expected_value": "systemic therapy"
                                }
                            },
                            {
                                "exact_snippets": "any infection requiring systemic therapy",
                                "criterion": "infection",
                                "requirement": {
                                    "requirement_type": "treatment",
                                    "expected_value": "systemic therapy"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "active hepatitis B",
                        "criterion": "hepatitis B",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "active hepatitis C",
                        "criterion": "hepatitis C",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "active ... human immunodeficiency virus (HIV)",
                        "criterion": "HIV",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "active ... tuberculosis",
                        "criterion": "tuberculosis",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Patients must be surgically or medically castrated, with testosterone levels of < 50 ng/dL (< 1.7 nM). Patients who have not undergone orchiectomy must continue (or restart if previously discontinued) LHRH therapy throughout the study.",
                "criterions": [
                    {
                        "exact_snippets": "surgically or medically castrated",
                        "criterion": "castration status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "surgically castrated",
                                "medically castrated"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "testosterone levels of < 50 ng/dL (< 1.7 nM)",
                        "criterion": "testosterone levels",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "ng/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Patients who have not undergone orchiectomy must continue (or restart if previously discontinued) LHRH therapy",
                        "criterion": "LHRH therapy",
                        "requirement": {
                            "requirement_type": "continuation",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "surgically or medically castrated",
                                "criterion": "castration status",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": [
                                        "surgically castrated"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "surgically or medically castrated",
                                "criterion": "castration status",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": [
                                        "medically castrated"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "testosterone levels of < 50 ng/dL (< 1.7 nM)",
                        "criterion": "testosterone levels",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "ng/dL"
                            }
                        }
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "surgically or medically castrated",
                                "criterion": "castration status",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": [
                                        "surgically castrated"
                                    ]
                                }
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "surgically or medically castrated",
                                        "criterion": "castration status",
                                        "requirement": {
                                            "requirement_type": "status",
                                            "expected_value": [
                                                "medically castrated"
                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "Patients who have not undergone orchiectomy must continue (or restart if previously discontinued) LHRH therapy",
                                        "criterion": "LHRH therapy",
                                        "requirement": {
                                            "requirement_type": "continuation",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* ECOG performance status 0 or 1.",
                "criterions": [
                    {
                        "exact_snippets": "ECOG performance status 0 or 1.",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "ECOG performance status 0 or 1.",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "0"
                        }
                    },
                    {
                        "exact_snippets": "ECOG performance status 0 or 1.",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "1"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* The longer of 30 days or 5 half-lives for investigational agents;",
                "criterions": [
                    {
                        "exact_snippets": "30 days or 5 half-lives for investigational agents",
                        "criterion": "washout period for investigational agents",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "=",
                                        "value": 30,
                                        "unit": "days"
                                    },
                                    {
                                        "operator": "=",
                                        "value": 5,
                                        "unit": "half-lives"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "30 days or 5 half-lives for investigational agents",
                        "criterion": "washout period for investigational agents",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 30,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "30 days or 5 half-lives for investigational agents",
                        "criterion": "washout period for investigational agents",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 5,
                                        "unit": "half-lives"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use male condom plus spermicide while on study and for 6 months after the last dose of durvalumab and tremelimumab, or for 3 months after the last dose of durvalumab alone. Female partners of a male subject must use a highly effective method of contraception throughout this period.",
                "criterions": [
                    {
                        "exact_snippets": "Non-sterilized male patients",
                        "criterion": "male sterilization status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "sexually active with a female partner of childbearing potential",
                        "criterion": "sexual activity with female partner of childbearing potential",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "must use male condom plus spermicide while on study and for 6 months after the last dose of durvalumab and tremelimumab, or for 3 months after the last dose of durvalumab alone",
                        "criterion": "contraceptive use by male patients",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": [
                                "male condom",
                                "spermicide"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "must use male condom plus spermicide while on study and for 6 months after the last dose of durvalumab and tremelimumab, or for 3 months after the last dose of durvalumab alone",
                        "criterion": "contraceptive use by male patients",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "while on study and for 6 months after the last dose of durvalumab and tremelimumab, or for 3 months after the last dose of durvalumab alone"
                        }
                    },
                    {
                        "exact_snippets": "Female partners of a male subject must use a highly effective method of contraception throughout this period",
                        "criterion": "contraceptive use by female partners",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": "highly effective method of contraception"
                        }
                    },
                    {
                        "exact_snippets": "Female partners of a male subject must use a highly effective method of contraception throughout this period",
                        "criterion": "contraceptive use by female partners",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "throughout this period"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Non-sterilized male patients",
                                "criterion": "male sterilization status",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "sexually active with a female partner of childbearing potential",
                                "criterion": "sexual activity with female partner of childbearing potential",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "must use male condom plus spermicide while on study and for 6 months after the last dose of durvalumab and tremelimumab, or for 3 months after the last dose of durvalumab alone",
                                        "criterion": "contraceptive use by male patients",
                                        "requirement": {
                                            "requirement_type": "method",
                                            "expected_value": [
                                                "male condom",
                                                "spermicide"
                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "must use male condom plus spermicide while on study and for 6 months after the last dose of durvalumab and tremelimumab, or for 3 months after the last dose of durvalumab alone",
                                        "criterion": "contraceptive use by male patients",
                                        "requirement": {
                                            "requirement_type": "duration",
                                            "expected_value": "while on study and for 6 months after the last dose of durvalumab and tremelimumab"
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "must use male condom plus spermicide while on study and for 6 months after the last dose of durvalumab and tremelimumab, or for 3 months after the last dose of durvalumab alone",
                                        "criterion": "contraceptive use by male patients",
                                        "requirement": {
                                            "requirement_type": "method",
                                            "expected_value": [
                                                "male condom",
                                                "spermicide"
                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "must use male condom plus spermicide while on study and for 6 months after the last dose of durvalumab and tremelimumab, or for 3 months after the last dose of durvalumab alone",
                                        "criterion": "contraceptive use by male patients",
                                        "requirement": {
                                            "requirement_type": "duration",
                                            "expected_value": "while on study and for 3 months after the last dose of durvalumab alone"
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Female partners of a male subject must use a highly effective method of contraception throughout this period",
                                "criterion": "contraceptive use by female partners",
                                "requirement": {
                                    "requirement_type": "method",
                                    "expected_value": "highly effective method of contraception"
                                }
                            },
                            {
                                "exact_snippets": "Female partners of a male subject must use a highly effective method of contraception throughout this period",
                                "criterion": "contraceptive use by female partners",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": "throughout this period"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate. Patients who cannot give informed consent (i.e. mentally incompetent patients, or those physically incapacitated such as comatose patients) are not to be recruited into the study. Patients competent but physically unable to sign the consent form may have the document signed by their nearest relative or legal guardian. Each patient will be provided with a full explanation of the study before consent is requested.",
                "criterions": [
                    {
                        "exact_snippets": "Patient consent must be appropriately obtained",
                        "criterion": "patient consent",
                        "requirement": {
                            "requirement_type": "appropriateness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Each patient must sign a consent form prior to enrollment",
                        "criterion": "consent form signing",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "prior to enrollment"
                        }
                    },
                    {
                        "exact_snippets": "Patients who cannot give informed consent (i.e. mentally incompetent patients, or those physically incapacitated such as comatose patients) are not to be recruited",
                        "criterion": "ability to give informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Patients competent but physically unable to sign the consent form may have the document signed by their nearest relative or legal guardian",
                        "criterion": "competence to consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}