{
    "info": {
        "nct_id": "NCT04659382",
        "official_title": "A Prospective, Multicenter, Open-label, Phase II Study to Evaluate Efficacy and Safety of Selective Internal Radiation Therapy Plus Xelox, Bevacizumab and Atezolizumab (Immune Chekpoint Inhibitor) in Patients With Liver-dominant Metastatic Colorectal Cancer",
        "inclusion_criteria": "* Age ≥18 years\n* Histologically proven mismatch repair proficient metastatic colorectal cancer (pMMR and/or MSS)\n* Liver-dominant disease with up to 6 extrahepatic lesions (only peritoneal lesions are not allowed) if asymptomatic and without organ dysfunction.\n* Measurable disease according to RECIST 1.1\n* Patient with initially unresectable disease according to the local multidisciplinary team and eligible for radioembolization according to the radiologist's opinion\n* Tumor volume < 50 % of total liver volume\n* No prior oncologic treatment for metastatic disease (i.e. chemotherapy, radiotherapy or investigational drug). Patients may have received adjuvant chemotherapy or (neo) adjuvant radiochemotherapy to the pelvis (tumor of the rectum), but the last dose of chemotherapy/radiotherapy must be administered at least 6 months prior to entry into this study. Analgesic radiotherapy of metastasis is permitted except on hepatic lesions and must be completed at least 14 days before inclusion.\n* WHO performance status ≤ 1\n* Estimated life expectancy ≥ 3 months\n* Adequate hematological function: with neutrophils ≥ 1,500 /mm3, platelet count ≥ 100,000/mm3, hemoglobin > 9 g/dL (5,6 mmol/l)\n* Adequate hepatic function: hepatic transaminases (ASAT and ALAT) ≤ 5 x UNL, total bilirubin ≤ 2 x UNL, alkaline phosphatase ≤ 5 x UNL\n* Adequate renal function: creatinine clearance ≥ 50 ml/min according MDRD (Modification of Diet in Renal Disease)\n* Patient affiliated to a social security system Information provided to patient and signature of the informed consent form by patient and the investigator\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Active infection still requiring intravenous antibiotics on the first scheduled day of protocol treatment\n* Symptomatic or untreated central nervous system metastasis\n* Medical history of other concomitant or previous malignant disease, except adequately treated in situ carcinoma of the uterine cervix, basal or squamous cell carcinoma of the skin, or cancer in complete remission for ≥ 5 years,\n* Other malignancy in the 5 years prior to inclusion in the study, except for localized cancer in situ, basal or squamous cell skin cancer\n* Confirmed peritoneal carcinomatosis (lesions detectable on CT-scan and/or MRI)\n* Active autoimmune disease or inflammatory bowel disease\n* Bone marrow allograft or solid organ transplant history\n* History of idiopathic pulmonary fibrosis, drug-induced pneumonitis or evidence of active pneumonitis on screening chest CT-scan and any severe chronic respiratory insufficiency that the investigator believes would not allow the SIRT to be received safely\n* Positive tests for HIV or other immunodeficiency syndromes\n* Severe chronic liver failure, which in the investigator's opinion would not allow SIRT to be received safely\n* Active hepatitis B or hepatitis C.\n* Active tuberculosis\n* Patient with contraindication to angiography and selective hepatic catheterization such as bleeding diathesis or coagulopathy with serious bleeding risk that is not correctable by usual therapy of hemostatic agents.\n* Patients on anticoagulant therapy different from low-molecular-weight heparin (LMWH) cannot be included (i.e. VKA and NOACs). Relaying these anticoagulants to a LMWH before inclusion is allowed. In addition, it must be possible to stop the LMWH 24 hours before invasive procedures according to the usual recommendations (before the work-up and before the SIRT).\n* Significant presence of ascites, cirrhosis, portal hypertension, main portal venous tumor involvement or thrombosis on clinical or radiological evaluation Previous radiotherapy in the upper abdominal region (liver or liver vessels in the radiation field)\n* If primary tumor is non-resected, it must be asymptomatic\n* Long-term immunosuppressant therapy (patients requiring corticosteroid therapy are eligible if they receive a dose equivalent to no more than 10 mg of prednisone equivalent dose per day, and corticosteroid administration is permitted by a route resulting in minimal systemic exposure (cutaneous, rectal, articular, ocular or inhalation) is authorized)\n* Partial or complete DPD deficiency\n* Known hypersensitivity to any components of bevacizumab, Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies and any other contraindications to the use of investigational medicinal products, in particular patients with peripheral sensory neuropathy with functional impairment (see SmPC of oxaliplatin) or in the case of recent or concomitant treatment with brivudine (see SmPC of capecitabine)\n* QT/QTc interval > 450 msec for male and > 470 msec for female at EKC.\n* K+ < LLN, Mg²+ < LLN, Ca²+ < LLN\n* Allergy to contrast agents that do not allow radioembolization to be performed\n* Uncontrolled hypertension (blood pressure > 140 mm Hg and/or diastolic blood pressure > 90 mm Hg)\n* Clinically significant cardiovascular disease, for example cerebrovascular accidents ≤ 6 months prior to the start of study treatment, myocardial infarction ≤ 6 months prior to the start of study treatment, unstable angina, congestive heart failure of NYHA (New York Heart Association Functional Classification) grade 2 or higher, or severe cardiac arrhythmia not controlled by drug therapy or which may interfere with study treatment\n* Significant vascular disease (e.g. aortic aneurysm requiring surgery or arterial thrombosis) within 6 months prior to initiation of study treatment\n* Venous thromboembolic disease within 3 months prior to initiation of study treatment\n* Surgical procedure (including surgical biopsy, any surgical resection, or other major surgery) or significant traumatic injury within 28 days prior to start of study treatment, or planning major surgery during the study.\n* History of abdominal fistula, gastrointestinal (GI) perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to start of study treatment\n* Unhealing decaying wound, active ulcer, or untreated bone fracture\n* Proteinuria ≥ 2+ by urine dipstick unless a 24-hour urine protein < 1 g of protein is demonstrated\n* Lack of effective contraception in patients (male and/or female) at risk of reproduction, pregnant or breastfeeding women and women at risk of reproduction who have not had a pregnancy test.\n* Persons deprived of freedom or under guardianship\n* Inability to undergo medical follow-up of the study for geographical, social or psychological reasons",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Age ≥18 years",
            "criterions": [
                {
                    "exact_snippets": "Age ≥18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically proven mismatch repair proficient metastatic colorectal cancer (pMMR and/or MSS)",
            "criterions": [
                {
                    "exact_snippets": "Histologically proven mismatch repair proficient metastatic colorectal cancer",
                    "criterion": "mismatch repair proficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic colorectal cancer",
                    "criterion": "metastatic colorectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pMMR and/or MSS",
                    "criterion": "pMMR and/or MSS",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Liver-dominant disease with up to 6 extrahepatic lesions (only peritoneal lesions are not allowed) if asymptomatic and without organ dysfunction.",
            "criterions": [
                {
                    "exact_snippets": "Liver-dominant disease",
                    "criterion": "liver-dominant disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "up to 6 extrahepatic lesions",
                    "criterion": "extrahepatic lesions",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "lesions"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "only peritoneal lesions are not allowed",
                    "criterion": "peritoneal lesions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "if asymptomatic",
                    "criterion": "symptoms",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "without organ dysfunction",
                    "criterion": "organ dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease according to RECIST 1.1",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease according to RECIST 1.1",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "criteria",
                            "expected_value": "RECIST 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient with initially unresectable disease according to the local multidisciplinary team and eligible for radioembolization according to the radiologist's opinion",
            "criterions": [
                {
                    "exact_snippets": "initially unresectable disease",
                    "criterion": "disease resectability",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "initially unresectable"
                        }
                    ]
                },
                {
                    "exact_snippets": "eligible for radioembolization according to the radiologist's opinion",
                    "criterion": "radioembolization eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": "radiologist's opinion"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tumor volume < 50 % of total liver volume",
            "criterions": [
                {
                    "exact_snippets": "Tumor volume < 50 % of total liver volume",
                    "criterion": "tumor volume",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "% of total liver volume"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior oncologic treatment for metastatic disease (i.e. chemotherapy, radiotherapy or investigational drug). Patients may have received adjuvant chemotherapy or (neo) adjuvant radiochemotherapy to the pelvis (tumor of the rectum), but the last dose of chemotherapy/radiotherapy must be administered at least 6 months prior to entry into this study. Analgesic radiotherapy of metastasis is permitted except on hepatic lesions and must be completed at least 14 days before inclusion.",
            "criterions": [
                {
                    "exact_snippets": "No prior oncologic treatment for metastatic disease (i.e. chemotherapy, radiotherapy or investigational drug)",
                    "criterion": "prior oncologic treatment for metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients may have received adjuvant chemotherapy or (neo) adjuvant radiochemotherapy to the pelvis (tumor of the rectum)",
                    "criterion": "adjuvant chemotherapy or (neo) adjuvant radiochemotherapy to the pelvis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "the last dose of chemotherapy/radiotherapy must be administered at least 6 months prior to entry into this study",
                    "criterion": "time since last dose of chemotherapy/radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Analgesic radiotherapy of metastasis is permitted except on hepatic lesions",
                    "criterion": "analgesic radiotherapy of metastasis on hepatic lesions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Analgesic radiotherapy of metastasis ... must be completed at least 14 days before inclusion",
                    "criterion": "time since completion of analgesic radiotherapy of metastasis",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WHO performance status ≤ 1",
            "criterions": [
                {
                    "exact_snippets": "WHO performance status ≤ 1",
                    "criterion": "WHO performance status",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Estimated life expectancy ≥ 3 months",
            "criterions": [
                {
                    "exact_snippets": "Estimated life expectancy ≥ 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate hematological function: with neutrophils ≥ 1,500 /mm3, platelet count ≥ 100,000/mm3, hemoglobin > 9 g/dL (5,6 mmol/l)",
            "criterions": [
                {
                    "exact_snippets": "Adequate hematological function: with neutrophils ≥ 1,500 /mm3",
                    "criterion": "neutrophils",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "/mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate hematological function: ... platelet count ≥ 100,000/mm3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "/mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate hematological function: ... hemoglobin > 9 g/dL (5,6 mmol/l)",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate hepatic function: hepatic transaminases (ASAT and ALAT) ≤ 5 x UNL, total bilirubin ≤ 2 x UNL, alkaline phosphatase ≤ 5 x UNL",
            "criterions": [
                {
                    "exact_snippets": "hepatic transaminases (ASAT and ALAT) ≤ 5 x UNL",
                    "criterion": "hepatic transaminases (ASAT and ALAT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "x UNL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "total bilirubin ≤ 2 x UNL",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "x UNL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alkaline phosphatase ≤ 5 x UNL",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "x UNL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate renal function: creatinine clearance ≥ 50 ml/min according MDRD (Modification of Diet in Renal Disease)",
            "criterions": [
                {
                    "exact_snippets": "Adequate renal function: creatinine clearance ≥ 50 ml/min",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "creatinine clearance",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "ml/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient affiliated to a social security system Information provided to patient and signature of the informed consent form by patient and the investigator",
            "criterions": [
                {
                    "exact_snippets": "Patient affiliated to a social security system",
                    "criterion": "social security system affiliation",
                    "requirements": [
                        {
                            "requirement_type": "affiliation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "signature of the informed consent form by patient",
                    "criterion": "informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "signature",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Active infection still requiring intravenous antibiotics on the first scheduled day of protocol treatment",
            "criterions": [
                {
                    "exact_snippets": "Active infection still requiring intravenous antibiotics",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "intravenous antibiotics"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Symptomatic or untreated central nervous system metastasis",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic ... central nervous system metastasis",
                    "criterion": "central nervous system metastasis",
                    "requirements": [
                        {
                            "requirement_type": "symptom presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "untreated central nervous system metastasis",
                    "criterion": "central nervous system metastasis",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Medical history of other concomitant or previous malignant disease, except adequately treated in situ carcinoma of the uterine cervix, basal or squamous cell carcinoma of the skin, or cancer in complete remission for ≥ 5 years,",
            "criterions": [
                {
                    "exact_snippets": "Medical history of other concomitant or previous malignant disease",
                    "criterion": "other malignant disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated in situ carcinoma of the uterine cervix",
                    "criterion": "in situ carcinoma of the uterine cervix",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "basal or squamous cell carcinoma of the skin",
                    "criterion": "basal or squamous cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "cancer in complete remission for ≥ 5 years",
                    "criterion": "cancer remission",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other malignancy in the 5 years prior to inclusion in the study, except for localized cancer in situ, basal or squamous cell skin cancer",
            "criterions": [
                {
                    "exact_snippets": "Other malignancy in the 5 years prior to inclusion in the study",
                    "criterion": "other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except for localized cancer in situ",
                    "criterion": "localized cancer in situ",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ... basal or squamous cell skin cancer",
                    "criterion": "basal or squamous cell skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Confirmed peritoneal carcinomatosis (lesions detectable on CT-scan and/or MRI)",
            "criterions": [
                {
                    "exact_snippets": "Confirmed peritoneal carcinomatosis",
                    "criterion": "peritoneal carcinomatosis",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "lesions detectable on CT-scan and/or MRI",
                    "criterion": "lesions",
                    "requirements": [
                        {
                            "requirement_type": "detectability",
                            "expected_value": [
                                "CT-scan",
                                "MRI"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active autoimmune disease or inflammatory bowel disease",
            "criterions": [
                {
                    "exact_snippets": "Active autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "inflammatory bowel disease",
                    "criterion": "inflammatory bowel disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bone marrow allograft or solid organ transplant history",
            "criterions": [
                {
                    "exact_snippets": "Bone marrow allograft",
                    "criterion": "bone marrow allograft history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "solid organ transplant history",
                    "criterion": "solid organ transplant history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of idiopathic pulmonary fibrosis, drug-induced pneumonitis or evidence of active pneumonitis on screening chest CT-scan and any severe chronic respiratory insufficiency that the investigator believes would not allow the SIRT to be received safely",
            "criterions": [
                {
                    "exact_snippets": "History of idiopathic pulmonary fibrosis",
                    "criterion": "idiopathic pulmonary fibrosis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "drug-induced pneumonitis",
                    "criterion": "drug-induced pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of active pneumonitis on screening chest CT-scan",
                    "criterion": "active pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any severe chronic respiratory insufficiency that the investigator believes would not allow the SIRT to be received safely",
                    "criterion": "severe chronic respiratory insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "investigator's belief",
                            "expected_value": "would not allow the SIRT to be received safely"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Positive tests for HIV or other immunodeficiency syndromes",
            "criterions": [
                {
                    "exact_snippets": "Positive tests for HIV",
                    "criterion": "HIV",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Positive tests for ... other immunodeficiency syndromes",
                    "criterion": "other immunodeficiency syndromes",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe chronic liver failure, which in the investigator's opinion would not allow SIRT to be received safely",
            "criterions": [
                {
                    "exact_snippets": "Severe chronic liver failure",
                    "criterion": "chronic liver failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "in the investigator's opinion would not allow SIRT to be received safely",
                    "criterion": "SIRT safety",
                    "requirements": [
                        {
                            "requirement_type": "opinion",
                            "expected_value": "investigator's opinion"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active hepatitis B or hepatitis C.",
            "criterions": [
                {
                    "exact_snippets": "Active hepatitis B",
                    "criterion": "hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Active ... hepatitis C",
                    "criterion": "hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active tuberculosis",
            "criterions": [
                {
                    "exact_snippets": "Active tuberculosis",
                    "criterion": "tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient with contraindication to angiography and selective hepatic catheterization such as bleeding diathesis or coagulopathy with serious bleeding risk that is not correctable by usual therapy of hemostatic agents.",
            "criterions": [
                {
                    "exact_snippets": "contraindication to angiography",
                    "criterion": "contraindication to angiography",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "contraindication to ... selective hepatic catheterization",
                    "criterion": "contraindication to selective hepatic catheterization",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "bleeding diathesis",
                    "criterion": "bleeding diathesis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "coagulopathy with serious bleeding risk",
                    "criterion": "coagulopathy with serious bleeding risk",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "serious bleeding risk that is not correctable by usual therapy of hemostatic agents",
                    "criterion": "serious bleeding risk not correctable by hemostatic agents",
                    "requirements": [
                        {
                            "requirement_type": "correctability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients on anticoagulant therapy different from low-molecular-weight heparin (LMWH) cannot be included (i.e. VKA and NOACs). Relaying these anticoagulants to a LMWH before inclusion is allowed. In addition, it must be possible to stop the LMWH 24 hours before invasive procedures according to the usual recommendations (before the work-up and before the SIRT).",
            "criterions": [
                {
                    "exact_snippets": "Patients on anticoagulant therapy different from low-molecular-weight heparin (LMWH) cannot be included",
                    "criterion": "anticoagulant therapy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "low-molecular-weight heparin (LMWH)"
                        }
                    ]
                },
                {
                    "exact_snippets": "it must be possible to stop the LMWH 24 hours before invasive procedures",
                    "criterion": "ability to stop LMWH",
                    "requirements": [
                        {
                            "requirement_type": "time before procedure",
                            "expected_value": {
                                "operator": ">=",
                                "value": 24,
                                "unit": "hours"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Significant presence of ascites, cirrhosis, portal hypertension, main portal venous tumor involvement or thrombosis on clinical or radiological evaluation Previous radiotherapy in the upper abdominal region (liver or liver vessels in the radiation field)",
            "criterions": [
                {
                    "exact_snippets": "Significant presence of ascites",
                    "criterion": "ascites",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Significant presence of ... cirrhosis",
                    "criterion": "cirrhosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Significant presence of ... portal hypertension",
                    "criterion": "portal hypertension",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Significant presence of ... main portal venous tumor involvement",
                    "criterion": "main portal venous tumor involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Significant presence of ... thrombosis",
                    "criterion": "thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous radiotherapy in the upper abdominal region",
                    "criterion": "previous radiotherapy in the upper abdominal region",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "liver or liver vessels in the radiation field",
                    "criterion": "liver or liver vessels in the radiation field",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If primary tumor is non-resected, it must be asymptomatic",
            "criterions": [
                {
                    "exact_snippets": "primary tumor is non-resected",
                    "criterion": "primary tumor resection status",
                    "requirements": [
                        {
                            "requirement_type": "resection status",
                            "expected_value": "non-resected"
                        }
                    ]
                },
                {
                    "exact_snippets": "primary tumor ... must be asymptomatic",
                    "criterion": "primary tumor symptoms",
                    "requirements": [
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "asymptomatic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Long-term immunosuppressant therapy (patients requiring corticosteroid therapy are eligible if they receive a dose equivalent to no more than 10 mg of prednisone equivalent dose per day, and corticosteroid administration is permitted by a route resulting in minimal systemic exposure (cutaneous, rectal, articular, ocular or inhalation) is authorized)",
            "criterions": [
                {
                    "exact_snippets": "Long-term immunosuppressant therapy",
                    "criterion": "long-term immunosuppressant therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "patients requiring corticosteroid therapy are eligible",
                    "criterion": "corticosteroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "if they receive a dose equivalent to no more than 10 mg of prednisone equivalent dose per day",
                    "criterion": "corticosteroid dose",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "mg of prednisone equivalent per day"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "corticosteroid administration is permitted by a route resulting in minimal systemic exposure (cutaneous, rectal, articular, ocular or inhalation)",
                    "criterion": "corticosteroid administration route",
                    "requirements": [
                        {
                            "requirement_type": "route",
                            "expected_value": [
                                "cutaneous",
                                "rectal",
                                "articular",
                                "ocular",
                                "inhalation"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Partial or complete DPD deficiency",
            "criterions": [
                {
                    "exact_snippets": "Partial or complete DPD deficiency",
                    "criterion": "DPD deficiency",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "partial",
                                "complete"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known hypersensitivity to any components of bevacizumab, Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies and any other contraindications to the use of investigational medicinal products, in particular patients with peripheral sensory neuropathy with functional impairment (see SmPC of oxaliplatin) or in the case of recent or concomitant treatment with brivudine (see SmPC of capecitabine)",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity to any components of bevacizumab",
                    "criterion": "hypersensitivity to bevacizumab",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known hypersensitivity to ... Chinese Hamster Ovary cell products",
                    "criterion": "hypersensitivity to Chinese Hamster Ovary cell products",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known hypersensitivity to ... other recombinant human or humanized antibodies",
                    "criterion": "hypersensitivity to recombinant human or humanized antibodies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any other contraindications to the use of investigational medicinal products",
                    "criterion": "contraindications to investigational medicinal products",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with peripheral sensory neuropathy with functional impairment",
                    "criterion": "peripheral sensory neuropathy with functional impairment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "recent or concomitant treatment with brivudine",
                    "criterion": "treatment with brivudine",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": "recent or concomitant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* QT/QTc interval > 450 msec for male and > 470 msec for female at EKC.",
            "criterions": [
                {
                    "exact_snippets": "QT/QTc interval > 450 msec for male",
                    "criterion": "QT/QTc interval for male",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 450,
                                "unit": "msec"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "QT/QTc interval ... > 470 msec for female",
                    "criterion": "QT/QTc interval for female",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 470,
                                "unit": "msec"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* K+ < LLN, Mg²+ < LLN, Ca²+ < LLN",
            "criterions": [
                {
                    "exact_snippets": "K+ < LLN",
                    "criterion": "potassium level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 0,
                                "unit": "LLN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Mg²+ < LLN",
                    "criterion": "magnesium level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 0,
                                "unit": "LLN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Ca²+ < LLN",
                    "criterion": "calcium level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 0,
                                "unit": "LLN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Allergy to contrast agents that do not allow radioembolization to be performed",
            "criterions": [
                {
                    "exact_snippets": "Allergy to contrast agents",
                    "criterion": "allergy to contrast agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "do not allow radioembolization to be performed",
                    "criterion": "radioembolization",
                    "requirements": [
                        {
                            "requirement_type": "feasibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled hypertension (blood pressure > 140 mm Hg and/or diastolic blood pressure > 90 mm Hg)",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled hypertension (blood pressure > 140 mm Hg ...",
                    "criterion": "blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "systolic",
                            "expected_value": {
                                "operator": ">",
                                "value": 140,
                                "unit": "mm Hg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled hypertension (... diastolic blood pressure > 90 mm Hg)",
                    "criterion": "diastolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "diastolic",
                            "expected_value": {
                                "operator": ">",
                                "value": 90,
                                "unit": "mm Hg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant cardiovascular disease, for example cerebrovascular accidents ≤ 6 months prior to the start of study treatment, myocardial infarction ≤ 6 months prior to the start of study treatment, unstable angina, congestive heart failure of NYHA (New York Heart Association Functional Classification) grade 2 or higher, or severe cardiac arrhythmia not controlled by drug therapy or which may interfere with study treatment",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant cardiovascular disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "cerebrovascular accidents ≤ 6 months prior to the start of study treatment",
                    "criterion": "cerebrovascular accidents",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction ≤ 6 months prior to the start of study treatment",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure of NYHA (New York Heart Association Functional Classification) grade 2 or higher",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "NYHA grade",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "severe cardiac arrhythmia not controlled by drug therapy or which may interfere with study treatment",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control by drug therapy",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "interference with study treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Significant vascular disease (e.g. aortic aneurysm requiring surgery or arterial thrombosis) within 6 months prior to initiation of study treatment",
            "criterions": [
                {
                    "exact_snippets": "Significant vascular disease (e.g. aortic aneurysm requiring surgery or arterial thrombosis)",
                    "criterion": "vascular disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 6 months prior to initiation of study treatment",
                    "criterion": "vascular disease",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Venous thromboembolic disease within 3 months prior to initiation of study treatment",
            "criterions": [
                {
                    "exact_snippets": "Venous thromboembolic disease within 3 months prior to initiation of study treatment",
                    "criterion": "venous thromboembolic disease",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Surgical procedure (including surgical biopsy, any surgical resection, or other major surgery) or significant traumatic injury within 28 days prior to start of study treatment, or planning major surgery during the study.",
            "criterions": [
                {
                    "exact_snippets": "Surgical procedure (including surgical biopsy, any surgical resection, or other major surgery) ... within 28 days prior to start of study treatment",
                    "criterion": "recent surgical procedure or injury",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "planning major surgery during the study",
                    "criterion": "planned major surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of abdominal fistula, gastrointestinal (GI) perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to start of study treatment",
            "criterions": [
                {
                    "exact_snippets": "History of abdominal fistula",
                    "criterion": "abdominal fistula",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "gastrointestinal (GI) perforation",
                    "criterion": "gastrointestinal perforation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "intra-abdominal abscess",
                    "criterion": "intra-abdominal abscess",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "active GI bleeding",
                    "criterion": "active GI bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unhealing decaying wound, active ulcer, or untreated bone fracture",
            "criterions": [
                {
                    "exact_snippets": "Unhealing decaying wound",
                    "criterion": "unhealing decaying wound",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active ulcer",
                    "criterion": "active ulcer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "untreated bone fracture",
                    "criterion": "untreated bone fracture",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Proteinuria ≥ 2+ by urine dipstick unless a 24-hour urine protein < 1 g of protein is demonstrated",
            "criterions": [
                {
                    "exact_snippets": "Proteinuria ≥ 2+ by urine dipstick",
                    "criterion": "proteinuria",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "+"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unless a 24-hour urine protein < 1 g of protein is demonstrated",
                    "criterion": "24-hour urine protein",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "g"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lack of effective contraception in patients (male and/or female) at risk of reproduction, pregnant or breastfeeding women and women at risk of reproduction who have not had a pregnancy test.",
            "criterions": [
                {
                    "exact_snippets": "Lack of effective contraception in patients (male and/or female) at risk of reproduction",
                    "criterion": "effective contraception",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "pregnant or breastfeeding women",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pregnant or breastfeeding women",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "women at risk of reproduction who have not had a pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Persons deprived of freedom or under guardianship",
            "criterions": [
                {
                    "exact_snippets": "Persons deprived of freedom",
                    "criterion": "freedom status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "deprived"
                        }
                    ]
                },
                {
                    "exact_snippets": "under guardianship",
                    "criterion": "guardianship status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "under guardianship"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability to undergo medical follow-up of the study for geographical, social or psychological reasons",
            "criterions": [
                {
                    "exact_snippets": "Inability to undergo medical follow-up ... geographical",
                    "criterion": "geographical reasons",
                    "requirements": [
                        {
                            "requirement_type": "ability to undergo follow-up",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Inability to undergo medical follow-up ... social",
                    "criterion": "social reasons",
                    "requirements": [
                        {
                            "requirement_type": "ability to undergo follow-up",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Inability to undergo medical follow-up ... psychological",
                    "criterion": "psychological reasons",
                    "requirements": [
                        {
                            "requirement_type": "ability to undergo follow-up",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}