{
    "info": {
        "nct_id": "NCT01334073",
        "official_title": "Phase I Study of the Combination of Axitinib (AX) Plus Everolimus (EV) in Patients With Malignant Advanced Solid Tumors",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion criteria\n\n* Histologically proven advanced adult solid tumors, with the exception of Hodgkin and non Hodgkin lymphoma. Patients with hepatocellular carcinomas (HCC) may be enrolled without histological documentation if they meet the consensus non-invasive diagnostic criteria.\n* Failure or contra-indication of all standard therapies, except for the patients with advanced renal cell carcinoma, enrolled at the recommended dose who will be naïve of previous lines of therapy while metastatic.\n* Age > 18 years\n* ECOG Performance status (PS) 0-1\n* Life expectancy > 3 months\n* Measurable/evaluable disease according to RECIST CRITERIA version 1.0\n* Acceptable biological values: Hemoglobin > 10g /dL; neutrophils > 1.5 x 109/L; platelets > 100 x 109/L, AST and ALT < 2.5 x the upper normal limits (UNL), or < 5 x UNL in case of liver metastases, GGT < 3 x the upper normal limits (UNL), PAL < 2.5 x the upper normal limits (UNL), or < 5 x UNL in case of liver metastases, serum bilirubin < 1.5 x ULN, creatinine clearance (Cockroft & Gault formula) > 60 mL/min.\n* 24 hours proteinuria ≤ 1 g/24 h\n* Albumin > 30 g/l\n* Amylase and lipase ≤ 1.5 UNL\n* Electrolytes (calcium, sodium, potassium, chlore, magnesium, phosphate) in the normal range. Supplementation could be possible before study entry.\n* Total cholesterol ≤ 2.5 UNL\n* Triglycerides ≤ 2.5 UNL\n* BP < 140/90\n* Washout period from last anticancer therapy, including radiation and surgery > 3 weeks and recovery of toxicities to NCI-CTC grade < 1.\n* Written informed Consent.\n* Use of effective contraceptive method (Intrauterine device, oral combined contraceptive) for women of child-bearing age or whose partner is included in the trial.\n* Patient with french social security.\n* Additional inclusion criteria before the association axitinib plus everolimus period\n* No toxicity with NCI-CTC grade > 2 at the end of axitinib alone period just before starting axitinib and everolimus (cycle 1)\n* BP < 140/ 90\n\nExclusion criteria\n\n* Brain metastasis\n* Severe underlying cardiovascular disease, even medically controlled, such as angina pectoris, myocardial infarction, cardiac insufficiency, cardiac failure, cerebral strokes, lower limb ischemic disease, thromboembolic disease, and any patient, who, in the investigator's opinion is at high risk for arterial or venous thromboembolism.\n* Hepatitis B or C carrier or at a chronic state\n* Uncontrolled hypertension, or diabetes mellitus despite medical treatment.\n* Inability to swallow pills\n* Unresolved pneumopathy, no need for antibiotherapy\n* Any medical or social condition, which; in the investigator's opinion, would jeopardize patient's safety, patient's compliance to the protocol, or the interpretation of study results. These conditions include (but are not limited to): severe infection, cardiac failure, chronic gastrointestinal disease compromising oral drug absorption, psychiatric illnesses, foreseeable poor treatment compliance with oral medications, patients living far away from the investigational centers, etc...\n* Hypersensitivity to Axitinib or Everolimus\n* Participation to another clinical trial, or use of an unapproved medication within 4 weeks prior to study treatment initiation.\n* Pregnant or lactating women."
    },
    "inclusion_lines": [
        {
            "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": [],
    "miscellaneous_lines": [
        {
            "line": "* Histologically proven advanced adult solid tumors, with the exception of Hodgkin and non Hodgkin lymphoma. Patients with hepatocellular carcinomas (HCC) may be enrolled without histological documentation if they meet the consensus non-invasive diagnostic criteria.",
            "criterions": [
                {
                    "exact_snippets": "Histologically proven advanced adult solid tumors",
                    "criterion": "advanced adult solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "histological proof",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "exception of Hodgkin and non Hodgkin lymphoma",
                    "criterion": "Hodgkin and non Hodgkin lymphoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with hepatocellular carcinomas (HCC) may be enrolled without histological documentation if they meet the consensus non-invasive diagnostic criteria",
                    "criterion": "hepatocellular carcinomas (HCC)",
                    "requirements": [
                        {
                            "requirement_type": "histological documentation",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "non-invasive diagnostic criteria",
                            "expected_value": "consensus"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Failure or contra-indication of all standard therapies, except for the patients with advanced renal cell carcinoma, enrolled at the recommended dose who will be naïve of previous lines of therapy while metastatic.",
            "criterions": [
                {
                    "exact_snippets": "Failure or contra-indication of all standard therapies",
                    "criterion": "standard therapies",
                    "requirements": [
                        {
                            "requirement_type": "failure or contra-indication",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with advanced renal cell carcinoma",
                    "criterion": "advanced renal cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients ... enrolled at the recommended dose",
                    "criterion": "enrollment at the recommended dose",
                    "requirements": [
                        {
                            "requirement_type": "enrollment",
                            "expected_value": "recommended dose"
                        }
                    ]
                },
                {
                    "exact_snippets": "patients ... who will be naïve of previous lines of therapy while metastatic",
                    "criterion": "previous lines of therapy while metastatic",
                    "requirements": [
                        {
                            "requirement_type": "naïvety",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age > 18 years",
            "criterions": [
                {
                    "exact_snippets": "Age > 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG Performance status (PS) 0-1",
            "criterions": [
                {
                    "exact_snippets": "ECOG Performance status (PS) 0-1",
                    "criterion": "ECOG Performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy > 3 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy > 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable/evaluable disease according to RECIST CRITERIA version 1.0",
            "criterions": [
                {
                    "exact_snippets": "Measurable/evaluable disease according to RECIST CRITERIA version 1.0",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": "according to RECIST CRITERIA version 1.0"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Acceptable biological values: Hemoglobin > 10g /dL; neutrophils > 1.5 x 109/L; platelets > 100 x 109/L, AST and ALT < 2.5 x the upper normal limits (UNL), or < 5 x UNL in case of liver metastases, GGT < 3 x the upper normal limits (UNL), PAL < 2.5 x the upper normal limits (UNL), or < 5 x UNL in case of liver metastases, serum bilirubin < 1.5 x ULN, creatinine clearance (Cockroft & Gault formula) > 60 mL/min.",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin > 10g /dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "neutrophils > 1.5 x 109/L",
                    "criterion": "neutrophils",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelets > 100 x 109/L",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 100,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST and ALT < 2.5 x the upper normal limits (UNL), or < 5 x UNL in case of liver metastases",
                    "criterion": "AST and ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 2.5,
                                        "unit": "x UNL"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 5,
                                        "unit": "x UNL"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "GGT < 3 x the upper normal limits (UNL)",
                    "criterion": "GGT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "x UNL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PAL < 2.5 x the upper normal limits (UNL), or < 5 x UNL in case of liver metastases",
                    "criterion": "PAL",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 2.5,
                                        "unit": "x UNL"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 5,
                                        "unit": "x UNL"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum bilirubin < 1.5 x ULN",
                    "criterion": "serum bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance (Cockroft & Gault formula) > 60 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 24 hours proteinuria ≤ 1 g/24 h",
            "criterions": [
                {
                    "exact_snippets": "24 hours proteinuria ≤ 1 g/24 h",
                    "criterion": "24 hours proteinuria",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "g/24 h"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Albumin > 30 g/l",
            "criterions": [
                {
                    "exact_snippets": "Albumin > 30 g/l",
                    "criterion": "albumin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "g/l"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Amylase and lipase ≤ 1.5 UNL",
            "criterions": [
                {
                    "exact_snippets": "Amylase ... ≤ 1.5 UNL",
                    "criterion": "amylase level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "UNL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "lipase ≤ 1.5 UNL",
                    "criterion": "lipase level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "UNL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Electrolytes (calcium, sodium, potassium, chlore, magnesium, phosphate) in the normal range. Supplementation could be possible before study entry.",
            "criterions": [
                {
                    "exact_snippets": "Electrolytes (calcium, sodium, potassium, chlore, magnesium, phosphate) in the normal range.",
                    "criterion": "electrolytes",
                    "requirements": [
                        {
                            "requirement_type": "normal range",
                            "expected_value": [
                                "calcium",
                                "sodium",
                                "potassium",
                                "chlore",
                                "magnesium",
                                "phosphate"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total cholesterol ≤ 2.5 UNL",
            "criterions": [
                {
                    "exact_snippets": "Total cholesterol ≤ 2.5 UNL",
                    "criterion": "total cholesterol",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "UNL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Triglycerides ≤ 2.5 UNL",
            "criterions": [
                {
                    "exact_snippets": "Triglycerides ≤ 2.5 UNL",
                    "criterion": "triglycerides",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "UNL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* BP < 140/90",
            "criterions": [
                {
                    "exact_snippets": "BP < 140/90",
                    "criterion": "blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 140,
                                        "unit": "mmHg"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 90,
                                        "unit": "mmHg"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Washout period from last anticancer therapy, including radiation and surgery > 3 weeks and recovery of toxicities to NCI-CTC grade < 1.",
            "criterions": [
                {
                    "exact_snippets": "Washout period from last anticancer therapy, including radiation and surgery > 3 weeks",
                    "criterion": "washout period from last anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "recovery of toxicities to NCI-CTC grade < 1",
                    "criterion": "recovery of toxicities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "NCI-CTC grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Written informed Consent.",
            "criterions": [
                {
                    "exact_snippets": "Written informed Consent.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of effective contraceptive method (Intrauterine device, oral combined contraceptive) for women of child-bearing age or whose partner is included in the trial.",
            "criterions": [
                {
                    "exact_snippets": "Use of effective contraceptive method ... for women of child-bearing age",
                    "criterion": "contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "women of child-bearing age",
                    "criterion": "child-bearing age",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "whose partner is included in the trial",
                    "criterion": "partner inclusion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient with french social security.",
            "criterions": [
                {
                    "exact_snippets": "french social security",
                    "criterion": "social security",
                    "requirements": [
                        {
                            "requirement_type": "country",
                            "expected_value": "France"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Additional inclusion criteria before the association axitinib plus everolimus period",
            "criterions": [
                {
                    "exact_snippets": "association axitinib plus everolimus period",
                    "criterion": "association axitinib plus everolimus period",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No toxicity with NCI-CTC grade > 2 at the end of axitinib alone period just before starting axitinib and everolimus (cycle 1)",
            "criterions": [
                {
                    "exact_snippets": "No toxicity with NCI-CTC grade > 2",
                    "criterion": "toxicity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "NCI-CTC grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* BP < 140/ 90",
            "criterions": [
                {
                    "exact_snippets": "BP < 140/ 90",
                    "criterion": "blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "systolic",
                            "expected_value": {
                                "operator": "<",
                                "value": 140,
                                "unit": "mmHg"
                            }
                        },
                        {
                            "requirement_type": "diastolic",
                            "expected_value": {
                                "operator": "<",
                                "value": 90,
                                "unit": "mmHg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Brain metastasis",
            "criterions": [
                {
                    "exact_snippets": "Brain metastasis",
                    "criterion": "brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe underlying cardiovascular disease, even medically controlled, such as angina pectoris, myocardial infarction, cardiac insufficiency, cardiac failure, cerebral strokes, lower limb ischemic disease, thromboembolic disease, and any patient, who, in the investigator's opinion is at high risk for arterial or venous thromboembolism.",
            "criterions": [
                {
                    "exact_snippets": "Severe underlying cardiovascular disease",
                    "criterion": "underlying cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "angina pectoris",
                    "criterion": "angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac insufficiency",
                    "criterion": "cardiac insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac failure",
                    "criterion": "cardiac failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cerebral strokes",
                    "criterion": "cerebral strokes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "lower limb ischemic disease",
                    "criterion": "lower limb ischemic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "thromboembolic disease",
                    "criterion": "thromboembolic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "high risk for arterial or venous thromboembolism",
                    "criterion": "risk for arterial or venous thromboembolism",
                    "requirements": [
                        {
                            "requirement_type": "risk level",
                            "expected_value": "high"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hepatitis B or C carrier or at a chronic state",
            "criterions": [
                {
                    "exact_snippets": "Hepatitis B or C carrier",
                    "criterion": "Hepatitis B or C carrier",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatitis B or C ... at a chronic state",
                    "criterion": "Hepatitis B or C chronic state",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled hypertension, or diabetes mellitus despite medical treatment.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "diabetes mellitus despite medical treatment",
                    "criterion": "diabetes mellitus",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability to swallow pills",
            "criterions": [
                {
                    "exact_snippets": "Inability to swallow pills",
                    "criterion": "ability to swallow pills",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unresolved pneumopathy, no need for antibiotherapy",
            "criterions": [
                {
                    "exact_snippets": "Unresolved pneumopathy",
                    "criterion": "pneumopathy",
                    "requirements": [
                        {
                            "requirement_type": "resolution",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no need for antibiotherapy",
                    "criterion": "antibiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any medical or social condition, which; in the investigator's opinion, would jeopardize patient's safety, patient's compliance to the protocol, or the interpretation of study results. These conditions include (but are not limited to): severe infection, cardiac failure, chronic gastrointestinal disease compromising oral drug absorption, psychiatric illnesses, foreseeable poor treatment compliance with oral medications, patients living far away from the investigational centers, etc...",
            "criterions": [
                {
                    "exact_snippets": "severe infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac failure",
                    "criterion": "cardiac failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic gastrointestinal disease compromising oral drug absorption",
                    "criterion": "gastrointestinal disease",
                    "requirements": [
                        {
                            "requirement_type": "chronicity",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "effect on drug absorption",
                            "expected_value": "compromising"
                        }
                    ]
                },
                {
                    "exact_snippets": "psychiatric illnesses",
                    "criterion": "psychiatric illnesses",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "foreseeable poor treatment compliance with oral medications",
                    "criterion": "treatment compliance",
                    "requirements": [
                        {
                            "requirement_type": "foreseeable compliance",
                            "expected_value": "poor"
                        }
                    ]
                },
                {
                    "exact_snippets": "patients living far away from the investigational centers",
                    "criterion": "distance from investigational centers",
                    "requirements": [
                        {
                            "requirement_type": "distance",
                            "expected_value": "far away"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hypersensitivity to Axitinib or Everolimus",
            "criterions": [
                {
                    "exact_snippets": "Hypersensitivity to Axitinib",
                    "criterion": "hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "substance",
                            "expected_value": "Axitinib"
                        }
                    ]
                },
                {
                    "exact_snippets": "Hypersensitivity to ... Everolimus",
                    "criterion": "hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "substance",
                            "expected_value": "Everolimus"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participation to another clinical trial, or use of an unapproved medication within 4 weeks prior to study treatment initiation.",
            "criterions": [
                {
                    "exact_snippets": "Participation to another clinical trial",
                    "criterion": "participation in another clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "use of an unapproved medication within 4 weeks prior to study treatment initiation",
                    "criterion": "use of an unapproved medication",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or lactating women.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Inclusion criteria",
            "criterions": []
        },
        {
            "line": "Exclusion criteria",
            "criterions": []
        }
    ]
}