{
    "info": {
        "nct_id": "NCT02879162",
        "official_title": "A Phase II Study of Durvalumab and Tremelimumab in Patients With Advanced Rare Tumours",
        "inclusion_criteria": "* Patients must have histologically and/or cytologically confirmed cancer that is advanced / metastatic / recurrent or unresectable and for which no curative therapy exists as follows:\n\n  1. Salivary carcinoma (excluding adenoid cystic carcinoma histology)\n  2. Carcinoma of unknown primary with tumour infiltrating lymphocytes (TILs) and/or expressing PD-L1\n  3. Mucosal melanoma\n  4. Acral melanoma\n  5. Osteosarcoma\n  6. Undifferentiated pleomorphic sarcoma\n  7. Clear cell carcinoma of the ovary\n  8. Squamous cell carcinoma of the anal canal (SCCA)\n* All patients must have a tumour tissue from their primary or metastatic tumour available\n* Presence of clinically and/or radiologically documented disease. All radiology studies must be performed within 28 days prior to registration (within 35 days if negative).\n\nAll 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:\n\nCT scan (with slice thickness of 5 mm) ≥ 10 mm --> longest diameter Lymph nodes by CT scan ≥ 15 mm --> measured in short axis\n\n* Patients must be ≥ 16 years of age.\n* Patients must have an ECOG performance status of 0 or 1.\n* Previous Therapy\n\nCytotoxic Chemotherapy:\n\nPatients may have received prior chemotherapy - no limit on number of prior regimens.\n\nOther Systemic Therapy:\n\nPatients may have received other prior therapies including, angiogenesis inhibitors, PARP inhibitors or signal transduction inhibitors (tyrosine kinase inhibitors). Prior therapy with PD-1/PD-L1 or CTLA-4 inhibitors is not allowed.\n\nPatients must have recovered from all reversible toxicity related to prior chemotherapy or systemic therapy (unless grade 1, irreversible, or considered by investigator as not clinically significant) and have adequate washout as follows:\n\nLongest of one of the following:\n\n* Two weeks\n* 5 half-lives for investigational agents\n* Standard cycle length of standard therapies\n\nRadiation:\n\nPrior external beam radiation is permitted provided a minimum of 28 days (4 weeks) have elapsed between the last dose of radiation and date of registration. Exceptions may be made for low-dose, non-myelosuppressive radiotherapy after consultation with CCTG senior investigator. Concurrent radiotherapy is not permitted. Patients planned for concurrent chemotherapy-radiation are not eligible.\n\nSurgery:\n\nPrevious surgery is permitted provided that a minimum of 28 days (4 weeks) have elapsed between any major surgery and date of registration, and that wound healing has occurred.\n\n* Lab Requirements:\n\nAbsolute neutrophils ≥ 1.5 x 10^9/L Platelets ≥ 100 x 10^9/L Hemoglobin ≥ 90 g/L Bilirubin ≤ 1.5 x ULN (upper limit of normal)* AST and ALT ≤ 2.5 x ULN (if liver metastases are present, ≤ 5 x ULN) Serum creatinine < 1.25 x ULN or: Creatinine clearance ≥ 40 mLs/min\n\n* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements\n* Women/men of childbearing potential must have agreed to use a highly effective contraceptive method.\n* Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating centre.\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* In accordance with CCTG policy, protocol treatment is to begin within 2 working days of patient registration\nHealthy volunteers allowed\nMust have minimum age of 16 Years",
        "exclusion_criteria": "* Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other cancers curatively treated with no evidence of disease for ≥ 5 years.\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 registration.\n* Live attenuated vaccination administered within 30 days prior to registration.\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* Untreated symptomatic brain metastases or brain metastases in whom radiation or surgery is indicated.\n* Concurrent treatment with other investigational drugs or anti-cancer therapy.\n* Patients with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol (incl 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  * Known pneumonitis or pulmonary fibrosis with clinically significant impairment of pulmonary function.\n* Pregnant or lactating women.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients must have histologically and/or cytologically confirmed cancer that is advanced / metastatic / recurrent or unresectable and for which no curative therapy exists as follows:",
            "criterions": [
                {
                    "exact_snippets": "histologically and/or cytologically confirmed cancer",
                    "criterion": "cancer confirmation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced / metastatic / recurrent or unresectable",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "advanced",
                                "metastatic",
                                "recurrent",
                                "unresectable"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "for which no curative therapy exists",
                    "criterion": "curative therapy",
                    "requirements": [
                        {
                            "requirement_type": "existence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Salivary carcinoma (excluding adenoid cystic carcinoma histology)",
            "criterions": [
                {
                    "exact_snippets": "Salivary carcinoma (excluding adenoid cystic carcinoma histology)",
                    "criterion": "salivary carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "histology",
                            "expected_value": "not adenoid cystic carcinoma"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Carcinoma of unknown primary with tumour infiltrating lymphocytes (TILs) and/or expressing PD-L1",
            "criterions": [
                {
                    "exact_snippets": "Carcinoma of unknown primary",
                    "criterion": "carcinoma of unknown primary",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tumour infiltrating lymphocytes (TILs)",
                    "criterion": "tumour infiltrating lymphocytes (TILs)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "expressing PD-L1",
                    "criterion": "PD-L1 expression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Mucosal melanoma",
            "criterions": [
                {
                    "exact_snippets": "Mucosal melanoma",
                    "criterion": "mucosal melanoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Acral melanoma",
            "criterions": [
                {
                    "exact_snippets": "Acral melanoma",
                    "criterion": "acral melanoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Osteosarcoma",
            "criterions": [
                {
                    "exact_snippets": "Osteosarcoma",
                    "criterion": "osteosarcoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Undifferentiated pleomorphic sarcoma",
            "criterions": [
                {
                    "exact_snippets": "Undifferentiated pleomorphic sarcoma",
                    "criterion": "undifferentiated pleomorphic sarcoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Clear cell carcinoma of the ovary",
            "criterions": [
                {
                    "exact_snippets": "Clear cell carcinoma of the ovary",
                    "criterion": "clear cell carcinoma of the ovary",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Squamous cell carcinoma of the anal canal (SCCA)",
            "criterions": [
                {
                    "exact_snippets": "Squamous cell carcinoma of the anal canal (SCCA)",
                    "criterion": "squamous cell carcinoma of the anal canal",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* All patients must have a tumour tissue from their primary or metastatic tumour available",
            "criterions": [
                {
                    "exact_snippets": "tumour tissue from their primary or metastatic tumour available",
                    "criterion": "tumour tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of clinically and/or radiologically documented disease. All radiology studies must be performed within 28 days prior to registration (within 35 days if negative).",
            "criterions": [
                {
                    "exact_snippets": "Presence of clinically and/or radiologically documented disease.",
                    "criterion": "documented disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "All radiology studies must be performed within 28 days prior to registration (within 35 days if negative).",
                    "criterion": "radiology studies",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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:",
            "criterions": [
                {
                    "exact_snippets": "at least one measurable lesion",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "as defined by RECIST 1.1",
                    "criterion": "RECIST 1.1 definition",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "that has not been the site of the protocol mandated biopsy",
                    "criterion": "biopsy site",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "protocol mandated biopsy site"
                        }
                    ]
                }
            ]
        },
        {
            "line": "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": "CT scan (with slice thickness of 5 mm) ≥ 10 mm",
                    "criterion": "CT scan slice thickness",
                    "requirements": [
                        {
                            "requirement_type": "thickness",
                            "expected_value": {
                                "operator": "=",
                                "value": 5,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "CT scan (with slice thickness of 5 mm) ≥ 10 mm",
                    "criterion": "longest diameter",
                    "requirements": [
                        {
                            "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 nodes size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "mm"
                            }
                        },
                        {
                            "requirement_type": "measurement axis",
                            "expected_value": "short axis"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be ≥ 16 years of age.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be ≥ 16 years of age.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 16,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have an ECOG performance status of 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status of 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous Therapy",
            "criterions": [
                {
                    "exact_snippets": "Previous Therapy",
                    "criterion": "previous therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Cytotoxic Chemotherapy:",
            "criterions": [
                {
                    "exact_snippets": "Cytotoxic Chemotherapy",
                    "criterion": "cytotoxic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Patients may have received prior chemotherapy - no limit on number of prior regimens.",
            "criterions": [
                {
                    "exact_snippets": "Patients may have received prior chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no limit on number of prior regimens",
                    "criterion": "number of prior chemotherapy regimens",
                    "requirements": [
                        {
                            "requirement_type": "limit",
                            "expected_value": "no limit"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Other Systemic Therapy:",
            "criterions": [
                {
                    "exact_snippets": "Other Systemic Therapy",
                    "criterion": "systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Patients may have received other prior therapies including, angiogenesis inhibitors, PARP inhibitors or signal transduction inhibitors (tyrosine kinase inhibitors). Prior therapy with PD-1/PD-L1 or CTLA-4 inhibitors is not allowed.",
            "criterions": [
                {
                    "exact_snippets": "Patients may have received other prior therapies including, angiogenesis inhibitors",
                    "criterion": "prior therapy with angiogenesis inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients may have received other prior therapies including, ... PARP inhibitors",
                    "criterion": "prior therapy with PARP inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients may have received other prior therapies including, ... signal transduction inhibitors (tyrosine kinase inhibitors)",
                    "criterion": "prior therapy with signal transduction inhibitors (tyrosine kinase inhibitors)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior therapy with PD-1/PD-L1 ... is not allowed",
                    "criterion": "prior therapy with PD-1/PD-L1 inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior therapy with ... CTLA-4 inhibitors is not allowed",
                    "criterion": "prior therapy with CTLA-4 inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Patients must have recovered from all reversible toxicity related to prior chemotherapy or systemic therapy (unless grade 1, irreversible, or considered by investigator as not clinically significant) and have adequate washout as follows:",
            "criterions": [
                {
                    "exact_snippets": "recovered from all reversible toxicity related to prior chemotherapy or systemic therapy",
                    "criterion": "reversible toxicity from prior chemotherapy or systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate washout",
                    "criterion": "washout period",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Longest of one of the following:",
            "criterions": [
                {
                    "exact_snippets": "Longest of one of the following",
                    "criterion": "tumor measurement",
                    "requirements": [
                        {
                            "requirement_type": "measurement type",
                            "expected_value": "longest"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Two weeks",
            "criterions": [
                {
                    "exact_snippets": "Two weeks",
                    "criterion": "time since last treatment",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 5 half-lives for investigational agents",
            "criterions": [
                {
                    "exact_snippets": "5 half-lives for investigational agents",
                    "criterion": "half-lives for investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 5,
                                "unit": "half-lives"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Standard cycle length of standard therapies",
            "criterions": [
                {
                    "exact_snippets": "Standard cycle length of standard therapies",
                    "criterion": "cycle length of therapies",
                    "requirements": [
                        {
                            "requirement_type": "standard",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Radiation:",
            "criterions": [
                {
                    "exact_snippets": "Radiation",
                    "criterion": "radiation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Prior external beam radiation is permitted provided a minimum of 28 days (4 weeks) have elapsed between the last dose of radiation and date of registration. Exceptions may be made for low-dose, non-myelosuppressive radiotherapy after consultation with CCTG senior investigator. Concurrent radiotherapy is not permitted. Patients planned for concurrent chemotherapy-radiation are not eligible.",
            "criterions": [
                {
                    "exact_snippets": "Prior external beam radiation is permitted provided a minimum of 28 days (4 weeks) have elapsed between the last dose of radiation and date of registration.",
                    "criterion": "prior external beam radiation",
                    "requirements": [
                        {
                            "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 senior investigator.",
                    "criterion": "low-dose, non-myelosuppressive radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": "consultation with CCTG senior investigator"
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent radiotherapy is not permitted.",
                    "criterion": "concurrent radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients planned for concurrent chemotherapy-radiation are not eligible.",
                    "criterion": "concurrent chemotherapy-radiation",
                    "requirements": [
                        {
                            "requirement_type": "planned treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Surgery:",
            "criterions": [
                {
                    "exact_snippets": "Surgery",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Previous surgery is permitted provided that a minimum of 28 days (4 weeks) have elapsed between any major surgery and date of registration, and that wound healing has occurred.",
            "criterions": [
                {
                    "exact_snippets": "Previous surgery is permitted",
                    "criterion": "previous surgery",
                    "requirements": [
                        {
                            "requirement_type": "permitted",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "a minimum of 28 days (4 weeks) have elapsed between any major surgery and date of registration",
                    "criterion": "time elapsed since major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "wound healing has occurred",
                    "criterion": "wound healing",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "occurred"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Absolute neutrophils ≥ 1.5 x 10^9/L Platelets ≥ 100 x 10^9/L Hemoglobin ≥ 90 g/L Bilirubin ≤ 1.5 x ULN (upper limit of normal)* AST and ALT ≤ 2.5 x ULN (if liver metastases are present, ≤ 5 x ULN) Serum creatinine < 1.25 x ULN or: Creatinine clearance ≥ 40 mLs/min",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophils ≥ 1.5 x 10^9/L",
                    "criterion": "absolute neutrophils",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelets ≥ 100 x 10^9/L",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hemoglobin ≥ 90 g/L",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Bilirubin ≤ 1.5 x ULN (upper limit of normal)",
                    "criterion": "bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST and ALT ≤ 2.5 x ULN (if liver metastases are present, ≤ 5 x ULN)",
                    "criterion": "AST and ALT",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "x ULN"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Serum creatinine < 1.25 x ULN",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.25,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Creatinine clearance ≥ 40 mLs/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 40,
                                "unit": "mLs/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements",
            "criterions": [
                {
                    "exact_snippets": "Patient consent must be appropriately obtained",
                    "criterion": "patient consent",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in accordance with applicable local and regulatory requirements",
                    "criterion": "compliance with local and regulatory requirements",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women/men of childbearing potential must have agreed to use a highly effective contraceptive method.",
            "criterions": [
                {
                    "exact_snippets": "Women/men of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must have agreed to use a highly effective contraceptive method",
                    "criterion": "use of contraceptive method",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": "highly effective"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating centre.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be accessible for treatment",
                    "criterion": "patient accessibility",
                    "requirements": [
                        {
                            "requirement_type": "accessibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients must be accessible for ... follow up",
                    "criterion": "patient accessibility for follow-up",
                    "requirements": [
                        {
                            "requirement_type": "accessibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients registered on this trial must be treated ... at the participating centre",
                    "criterion": "treatment location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "participating centre"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients registered on this trial must be ... followed at the participating centre",
                    "criterion": "follow-up location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "participating centre"
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "restriction",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "for at least 90 days following the last infusion of durvalumab or tremelimumab",
                    "criterion": "blood donation",
                    "requirements": [
                        {
                            "requirement_type": "restriction_duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* In accordance with CCTG policy, protocol treatment is to begin within 2 working days of patient registration",
            "criterions": [
                {
                    "exact_snippets": "protocol treatment is to begin within 2 working days of patient registration",
                    "criterion": "protocol treatment initiation",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "working days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 16 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 16 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 16,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other cancers curatively treated with no evidence of disease for ≥ 5 years.",
            "criterions": [
                {
                    "exact_snippets": "history of other malignancies",
                    "criterion": "history of other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated non-melanoma skin cancer",
                    "criterion": "non-melanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "curatively treated in-situ cancer of the cervix",
                    "criterion": "in-situ cancer of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "curatively treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "other cancers curatively treated with no evidence of disease for ≥ 5 years",
                    "criterion": "other cancers",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "curatively treated"
                        },
                        {
                            "requirement_type": "disease evidence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "disease-free duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "inflammatory bowel disease (e.g. colitis or Crohn's disease)",
                    "criterion": "inflammatory bowel disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "diverticulitis with the exception of diverticulosis",
                    "criterion": "diverticulitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "celiac disease",
                    "criterion": "celiac disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "serious gastrointestinal chronic conditions associated with diarrhea",
                    "criterion": "serious gastrointestinal chronic conditions associated with diarrhea",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "systemic lupus erythematosus",
                    "criterion": "systemic lupus erythematosus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Sarcoidosis syndrome",
                    "criterion": "Sarcoidosis syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Wegener syndrome (granulomatosis with polyangiitis)",
                    "criterion": "Wegener syndrome (granulomatosis with polyangiitis)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "rheumatoid arthritis",
                    "criterion": "rheumatoid arthritis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypophysitis",
                    "criterion": "hypophysitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uveitis",
                    "criterion": "uveitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within the past 3 years prior to the start of treatment",
                    "criterion": "time since condition",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with alopecia.",
            "criterions": [
                {
                    "exact_snippets": "Patients with alopecia.",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with Grave's disease, vitiligo or psoriasis not requiring systemic treatment (within the last 2 years).",
            "criterions": [
                {
                    "exact_snippets": "Patients with Grave's disease",
                    "criterion": "Grave's disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "vitiligo",
                    "criterion": "vitiligo",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "psoriasis",
                    "criterion": "psoriasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "not requiring systemic treatment",
                    "criterion": "systemic treatment requirement",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "within the last 2 years",
                    "criterion": "time since last systemic treatment",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement.",
            "criterions": [
                {
                    "exact_snippets": "Patients with hypothyroidism",
                    "criterion": "hypothyroidism",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "stable on hormone replacement",
                    "criterion": "hormone replacement",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of primary immunodeficiency, history of allogenic organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of registration.",
            "criterions": [
                {
                    "exact_snippets": "History of primary immunodeficiency",
                    "criterion": "primary immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of allogenic organ transplant that requires therapeutic immunosuppression",
                    "criterion": "allogenic organ transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "therapeutic immunosuppression",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "use of immunosuppressive agents within 28 days of registration",
                    "criterion": "use of immunosuppressive agents",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Live attenuated vaccination administered within 30 days prior to registration.",
            "criterions": [
                {
                    "exact_snippets": "Live attenuated vaccination administered within 30 days prior to registration.",
                    "criterion": "live attenuated vaccination",
                    "requirements": [
                        {
                            "requirement_type": "administration timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days prior to registration"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "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",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Any previous treatment with ... an anti-CTLA4, including tremelimumab.",
                    "criterion": "previous treatment with anti-CTLA4",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        },
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic cardiac dysfunction",
                    "criterion": "cardiac dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "symptoms",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction within the previous year",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac ventricular arrhythmias requiring medication",
                    "criterion": "cardiac ventricular arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of 2nd or 3rd degree atrioventricular conduction defects",
                    "criterion": "atrioventricular conduction defects",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": [
                                "2nd degree",
                                "3rd degree"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "significant cardiac history, even if controlled",
                    "criterion": "significant cardiac history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "LVEF ≥ 50%",
                    "criterion": "LVEF",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Untreated symptomatic brain metastases or brain metastases in whom radiation or surgery is indicated.",
            "criterions": [
                {
                    "exact_snippets": "Untreated symptomatic brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        },
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "symptomatic"
                        }
                    ]
                },
                {
                    "exact_snippets": "brain metastases ... radiation or surgery is indicated",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment indication",
                            "expected_value": [
                                "radiation",
                                "surgery"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent treatment with other investigational drugs or anti-cancer therapy.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent treatment with other investigational drugs",
                    "criterion": "concurrent treatment with investigational drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent treatment with ... anti-cancer therapy",
                    "criterion": "concurrent treatment with anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol (incl 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",
                    "requirements": [
                        {
                            "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",
                    "requirements": [
                        {
                            "requirement_type": "risk to patient",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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 or psychiatric disorder",
                    "criterion": "neurologic or psychiatric disorder",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "impair the ability to obtain consent",
                    "criterion": "ability to obtain consent",
                    "requirements": [
                        {
                            "requirement_type": "impairment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "limit compliance with study requirements",
                    "criterion": "compliance with study requirements",
                    "requirements": [
                        {
                            "requirement_type": "limitation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active peptic ulcer disease or gastritis.",
            "criterions": [
                {
                    "exact_snippets": "Active peptic ulcer disease",
                    "criterion": "peptic ulcer disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "gastritis",
                    "criterion": "gastritis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known pneumonitis or pulmonary fibrosis with clinically significant impairment of pulmonary function.",
            "criterions": [
                {
                    "exact_snippets": "Known pneumonitis",
                    "criterion": "pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pulmonary fibrosis",
                    "criterion": "pulmonary fibrosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant impairment of pulmonary function",
                    "criterion": "pulmonary function",
                    "requirements": [
                        {
                            "requirement_type": "impairment",
                            "expected_value": "clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or lactating women.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Lab Requirements:",
            "criterions": []
        }
    ],
    "failed_exclusion": [
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "active hepatitis B",
                    "criterion": "hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "active hepatitis C",
                    "criterion": "hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "active ... human immunodeficiency virus (HIV)",
                    "criterion": "HIV",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "active ... tuberculosis",
                    "criterion": "tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "any infection requiring systemic therapy",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic therapy"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}