{
    "info": {
        "nct_id": "NCT01706120",
        "official_title": "A MULTICENTER STUDY IN PATIENTS WITH STAGE III-IV EPITHELIAL OVARIAN CANCER TREATED WITH CARBOPLATIN/PACLITAXEL WITH BEVACIZUMAB: CLINICAL AND BIOLOGICAL PROGNOSTIC FACTORS",
        "inclusion_criteria": "* Female patients ≥18 years of age.\n* Patients with histologically confirmed epithelial ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, including mixed Mullerian Tumours Or Recurrent early stage epithelial ovarian or fallopian tube carcinoma treated with surgery alone.\n* FIGO stage IIIB & C or IV\n* ECOG Performance Status of 0-2.\n* Life expectancy of at least 12 weeks.\n* Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the study requirements.\n* Availability of tumour samples for molecular analyses\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "Cancer related\n\n* Ovarian tumours with low malignant potential (i.e. borderline tumours)\n* Previous systemic anti-cancer therapy for advanced ovarian cancer.\n* History or evidence of brain metastases or spinal cord compression.\n* History or evidence of synchronous primary endometrial carcinoma, unless all of the following criteria related to the endometrial carcinoma are met:\n\n  * stage ≤Ia\n  * no more than superficial myometrial invasion\n  * no lymphovascular invasion\n  * not poorly differentiated (grade 3 or papillary serous or clear cell carcinoma).\n* Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.\n\nOther-treatment related\n\n* Any prior radiotherapy to the pelvis or abdomen.\n* Surgery (including open biopsy) within 4 weeks prior to the first bevacizumab dose or planned (In this case the patient can be enrolled but the administration of bevacizumab should be omitted at first cycle).\n* Current or recent (within 10 days prior to the first study drug dose) use of full-dose oral or parenteral anticoagulant or thrombolytic agent for therapeutic purposes (except for central venous access patency, in which case international normalized ratio [INR] must be maintained below 1.5). Post operative prophylaxis with low molecular weight heparin sc is allowed.\n* Current or recent (within 30 days of first study dosing) treatment with another investigational drug.\n\nLaboratory related\n\n* Inadequate bone marrow function: ANC: <1.5 x 109/l, or platelet count <100 x 109/l or Haemoglobin <9 g/dl. Patients may be transfused to maintain haemoglobin values ≥9 g/dl.\n* Inadequate coagulation parameters:\n\n  * activated partial thromboplastin time (APTT) >1.5 xULN or\n  * INR >1.5\n* Inadequate liver function, defined as:\n\n  * serum (total) bilirubin >1.5 x the upper limit of normal (ULN) for the institution\n  * AST/SGOT or ALT/SGPT >2.5 x ULN.\n* Inadequate renal function, defined as serum creatinine >2.0 mg/dl or >177 micromol/l\n* Proteinuria >1g in a 24-hour urine collection (to be performed only among patients who showed a ≥3+ at urine dipstick).\n\nPatient related\n\n* Pregnant or lactating patients.\n* History or evidence of thrombotic or hemorrhagic disorders; including cerebrovascular accident (CVA) / stroke or transient ischemic attack (TIA) or sub-arachnoid haemorrhage within ≤6 months prior to the first study treatment).\n* Uncontrolled hypertension (sustained systolic >150 mm Hg and/or diastolic >100 mm Hg despite antihypertensive therapy) or clinically significant (i.e. active) cardiovascular disease, including:\n\n  * myocardial infarction or unstable angina within ≤6 months prior to the first study treatment\n  * New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF)\n  * serious cardiac arrhythmia requiring medication (with the exception of atrial fibrillation or paroxysmal supraventricular tachycardia)\n  * peripheral vascular disease ≥grade 3 (i.e. symptomatic and interfering with activities of daily living requiring repair or revision).\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the first study treatment.\n* Non-healing wound, ulcer or bone fracture. Patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require three weekly wound examinations.\n* Evidence of any other medical conditions (such as psychiatric illness, peptic ulcer, etc.), physical examination or laboratory findings that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complications.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Female patients ≥18 years of age.",
            "criterions": [
                {
                    "exact_snippets": "Female patients",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected gender",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "≥18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with histologically confirmed epithelial ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, including mixed Mullerian Tumours Or Recurrent early stage epithelial ovarian or fallopian tube carcinoma treated with surgery alone.",
            "criterions": [
                {
                    "exact_snippets": "histologically confirmed epithelial ovarian carcinoma",
                    "criterion": "epithelial ovarian carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically confirmed ... fallopian tube carcinoma",
                    "criterion": "fallopian tube carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically confirmed ... primary peritoneal carcinoma",
                    "criterion": "primary peritoneal carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "mixed Mullerian Tumours",
                    "criterion": "mixed Mullerian Tumours",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Recurrent early stage epithelial ovarian ... carcinoma",
                    "criterion": "recurrent early stage epithelial ovarian carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "surgery alone"
                        }
                    ]
                },
                {
                    "exact_snippets": "Recurrent early stage ... fallopian tube carcinoma",
                    "criterion": "recurrent early stage fallopian tube carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "surgery alone"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* FIGO stage IIIB & C or IV",
            "criterions": [
                {
                    "exact_snippets": "FIGO stage IIIB & C or IV",
                    "criterion": "FIGO stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "IIIB",
                                "C",
                                "IV"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG Performance Status of 0-2.",
            "criterions": [
                {
                    "exact_snippets": "ECOG Performance Status of 0-2",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of at least 12 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of at least 12 weeks.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the study requirements.",
            "criterions": [
                {
                    "exact_snippets": "Signed informed consent obtained",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Availability of tumour samples for molecular analyses",
            "criterions": [
                {
                    "exact_snippets": "Availability of tumour samples",
                    "criterion": "tumour samples",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "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 be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "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": "Cancer related",
            "criterions": [
                {
                    "exact_snippets": "Cancer related",
                    "criterion": "cancer",
                    "requirements": [
                        {
                            "requirement_type": "related",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ovarian tumours with low malignant potential (i.e. borderline tumours)",
            "criterions": [
                {
                    "exact_snippets": "Ovarian tumours with low malignant potential (i.e. borderline tumours)",
                    "criterion": "ovarian tumours",
                    "requirements": [
                        {
                            "requirement_type": "malignant potential",
                            "expected_value": "low"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous systemic anti-cancer therapy for advanced ovarian cancer.",
            "criterions": [
                {
                    "exact_snippets": "Previous systemic anti-cancer therapy for advanced ovarian cancer.",
                    "criterion": "systemic anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced ovarian cancer.",
                    "criterion": "ovarian cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History or evidence of brain metastases or spinal cord compression.",
            "criterions": [
                {
                    "exact_snippets": "History or evidence of brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History or evidence of ... spinal cord compression",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History or evidence of synchronous primary endometrial carcinoma, unless all of the following criteria related to the endometrial carcinoma are met:",
            "criterions": [
                {
                    "exact_snippets": "History or evidence of synchronous primary endometrial carcinoma",
                    "criterion": "synchronous primary endometrial carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* stage ≤Ia",
            "criterions": [
                {
                    "exact_snippets": "stage ≤Ia",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "a"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* no more than superficial myometrial invasion",
            "criterions": [
                {
                    "exact_snippets": "superficial myometrial invasion",
                    "criterion": "myometrial invasion",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "superficial"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* no lymphovascular invasion",
            "criterions": [
                {
                    "exact_snippets": "no lymphovascular invasion",
                    "criterion": "lymphovascular invasion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* not poorly differentiated (grade 3 or papillary serous or clear cell carcinoma).",
            "criterions": [
                {
                    "exact_snippets": "not poorly differentiated (grade 3",
                    "criterion": "tumor differentiation",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": "!=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "not ... papillary serous",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "not papillary serous"
                        }
                    ]
                },
                {
                    "exact_snippets": "not ... clear cell carcinoma",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "not clear cell carcinoma"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.",
            "criterions": [
                {
                    "exact_snippets": "Other malignancy within the last 5 years",
                    "criterion": "other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated carcinoma in situ of the cervix",
                    "criterion": "carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "squamous carcinoma of the skin",
                    "criterion": "squamous carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately controlled limited basal cell skin cancer",
                    "criterion": "basal cell skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Other-treatment related",
            "criterions": [
                {
                    "exact_snippets": "Other-treatment related",
                    "criterion": "other treatment",
                    "requirements": [
                        {
                            "requirement_type": "relatedness",
                            "expected_value": "related"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any prior radiotherapy to the pelvis or abdomen.",
            "criterions": [
                {
                    "exact_snippets": "prior radiotherapy to the pelvis",
                    "criterion": "prior radiotherapy to the pelvis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior radiotherapy to the ... abdomen",
                    "criterion": "prior radiotherapy to the abdomen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Surgery (including open biopsy) within 4 weeks prior to the first bevacizumab dose or planned (In this case the patient can be enrolled but the administration of bevacizumab should be omitted at first cycle).",
            "criterions": [
                {
                    "exact_snippets": "Surgery (including open biopsy) within 4 weeks prior to the first bevacizumab dose",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "planned",
                    "criterion": "planned surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current or recent (within 10 days prior to the first study drug dose) use of full-dose oral or parenteral anticoagulant or thrombolytic agent for therapeutic purposes (except for central venous access patency, in which case international normalized ratio [INR] must be maintained below 1.5). Post operative prophylaxis with low molecular weight heparin sc is allowed.",
            "criterions": [
                {
                    "exact_snippets": "Current or recent (within 10 days prior to the first study drug dose) use of full-dose oral or parenteral anticoagulant or thrombolytic agent for therapeutic purposes",
                    "criterion": "use of anticoagulant or thrombolytic agent",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "current or recent (within 10 days prior to the first study drug dose)"
                        },
                        {
                            "requirement_type": "dose",
                            "expected_value": "full-dose"
                        },
                        {
                            "requirement_type": "route",
                            "expected_value": [
                                "oral",
                                "parenteral"
                            ]
                        },
                        {
                            "requirement_type": "purpose",
                            "expected_value": "therapeutic"
                        }
                    ]
                },
                {
                    "exact_snippets": "central venous access patency, in which case international normalized ratio [INR] must be maintained below 1.5",
                    "criterion": "INR for central venous access patency",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Post operative prophylaxis with low molecular weight heparin sc is allowed",
                    "criterion": "post operative prophylaxis with low molecular weight heparin",
                    "requirements": [
                        {
                            "requirement_type": "route",
                            "expected_value": "sc"
                        },
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current or recent (within 30 days of first study dosing) treatment with another investigational drug.",
            "criterions": [
                {
                    "exact_snippets": "Current or recent (within 30 days of first study dosing) treatment with another investigational drug.",
                    "criterion": "treatment with another investigational drug",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 30,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Laboratory related",
            "criterions": [
                {
                    "exact_snippets": "Laboratory related",
                    "criterion": "laboratory tests",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "related"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inadequate bone marrow function: ANC: <1.5 x 109/l, or platelet count <100 x 109/l or Haemoglobin <9 g/dl. Patients may be transfused to maintain haemoglobin values ≥9 g/dl.",
            "criterions": [
                {
                    "exact_snippets": "Inadequate bone marrow function: ANC: <1.5 x 109/l",
                    "criterion": "ANC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x 10^9/l"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Inadequate bone marrow function: ... platelet count <100 x 109/l",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 100,
                                "unit": "x 10^9/l"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Inadequate bone marrow function: ... Haemoglobin <9 g/dl",
                    "criterion": "Haemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 9,
                                "unit": "g/dl"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients may be transfused to maintain haemoglobin values ≥9 g/dl",
                    "criterion": "haemoglobin maintenance",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inadequate coagulation parameters:",
            "criterions": [
                {
                    "exact_snippets": "Inadequate coagulation parameters",
                    "criterion": "coagulation parameters",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* activated partial thromboplastin time (APTT) >1.5 xULN or",
            "criterions": [
                {
                    "exact_snippets": "activated partial thromboplastin time (APTT) >1.5 xULN",
                    "criterion": "activated partial thromboplastin time (APTT)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "xULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* INR >1.5",
            "criterions": [
                {
                    "exact_snippets": "INR >1.5",
                    "criterion": "INR",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inadequate liver function, defined as:",
            "criterions": [
                {
                    "exact_snippets": "Inadequate liver function",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* serum (total) bilirubin >1.5 x the upper limit of normal (ULN) for the institution",
            "criterions": [
                {
                    "exact_snippets": "serum (total) bilirubin >1.5 x the upper limit of normal (ULN)",
                    "criterion": "serum (total) bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST/SGOT or ALT/SGPT >2.5 x ULN.",
            "criterions": [
                {
                    "exact_snippets": "AST/SGOT ... >2.5 x ULN",
                    "criterion": "AST/SGOT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT/SGPT >2.5 x ULN",
                    "criterion": "ALT/SGPT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inadequate renal function, defined as serum creatinine >2.0 mg/dl or >177 micromol/l",
            "criterions": [
                {
                    "exact_snippets": "Inadequate renal function, defined as serum creatinine >2.0 mg/dl",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.0,
                                "unit": "mg/dl"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Inadequate renal function, defined as serum creatinine ... >177 micromol/l",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 177,
                                "unit": "micromol/l"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Proteinuria >1g in a 24-hour urine collection (to be performed only among patients who showed a ≥3+ at urine dipstick).",
            "criterions": [
                {
                    "exact_snippets": "Proteinuria >1g in a 24-hour urine collection",
                    "criterion": "proteinuria",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "g"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "≥3+ at urine dipstick",
                    "criterion": "urine dipstick result",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": ">=3+"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or lactating patients.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History or evidence of thrombotic or hemorrhagic disorders; including cerebrovascular accident (CVA) / stroke or transient ischemic attack (TIA) or sub-arachnoid haemorrhage within ≤6 months prior to the first study treatment).",
            "criterions": [
                {
                    "exact_snippets": "History or evidence of thrombotic or hemorrhagic disorders",
                    "criterion": "thrombotic or hemorrhagic disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "cerebrovascular accident (CVA) / stroke ... within ≤6 months prior to the first study treatment",
                    "criterion": "cerebrovascular accident (CVA) / stroke",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "transient ischemic attack (TIA) ... within ≤6 months prior to the first study treatment",
                    "criterion": "transient ischemic attack (TIA)",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "sub-arachnoid haemorrhage within ≤6 months prior to the first study treatment",
                    "criterion": "sub-arachnoid haemorrhage",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled hypertension (sustained systolic >150 mm Hg and/or diastolic >100 mm Hg despite antihypertensive therapy) or clinically significant (i.e. active) cardiovascular disease, including:",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled hypertension (sustained systolic >150 mm Hg and/or diastolic >100 mm Hg despite antihypertensive therapy)",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "systolic blood pressure",
                            "expected_value": {
                                "operator": ">",
                                "value": 150,
                                "unit": "mm Hg"
                            }
                        },
                        {
                            "requirement_type": "diastolic blood pressure",
                            "expected_value": {
                                "operator": ">",
                                "value": 100,
                                "unit": "mm Hg"
                            }
                        },
                        {
                            "requirement_type": "antihypertensive therapy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant (i.e. active) cardiovascular disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* myocardial infarction or unstable angina within ≤6 months prior to the first study treatment",
            "criterions": [
                {
                    "exact_snippets": "myocardial infarction ... within ≤6 months prior to the first study treatment",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina within ≤6 months prior to the first study treatment",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF)",
            "criterions": [
                {
                    "exact_snippets": "New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF)",
                    "criterion": "congestive heart failure (CHF)",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "NYHA grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* serious cardiac arrhythmia requiring medication (with the exception of atrial fibrillation or paroxysmal supraventricular tachycardia)",
            "criterions": [
                {
                    "exact_snippets": "serious cardiac arrhythmia requiring medication",
                    "criterion": "serious cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "requiring medication"
                        }
                    ]
                },
                {
                    "exact_snippets": "(with the exception of atrial fibrillation or paroxysmal supraventricular tachycardia)",
                    "criterion": "atrial fibrillation or paroxysmal supraventricular tachycardia",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* peripheral vascular disease ≥grade 3 (i.e. symptomatic and interfering with activities of daily living requiring repair or revision).",
            "criterions": [
                {
                    "exact_snippets": "peripheral vascular disease ≥grade 3",
                    "criterion": "peripheral vascular disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic and interfering with activities of daily living",
                    "criterion": "peripheral vascular disease",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "interference with activities of daily living",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring repair or revision",
                    "criterion": "peripheral vascular disease",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": [
                                "repair",
                                "revision"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the first study treatment.",
            "criterions": [
                {
                    "exact_snippets": "History of abdominal fistula",
                    "criterion": "abdominal fistula",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... gastrointestinal perforation",
                    "criterion": "gastrointestinal perforation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... intra-abdominal abscess",
                    "criterion": "intra-abdominal abscess",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Non-healing wound, ulcer or bone fracture. Patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require three weekly wound examinations.",
            "criterions": [
                {
                    "exact_snippets": "Non-healing wound",
                    "criterion": "wound healing status",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "non-healing"
                        }
                    ]
                },
                {
                    "exact_snippets": "ulcer",
                    "criterion": "ulcer presence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "bone fracture",
                    "criterion": "bone fracture presence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "granulating incisions healing by secondary intention",
                    "criterion": "incision healing status",
                    "requirements": [
                        {
                            "requirement_type": "healing method",
                            "expected_value": "secondary intention"
                        }
                    ]
                },
                {
                    "exact_snippets": "no evidence of fascial dehiscence",
                    "criterion": "fascial dehiscence",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no evidence of...infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of any other medical conditions (such as psychiatric illness, peptic ulcer, etc.), physical examination or laboratory findings that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complications.",
            "criterions": [
                {
                    "exact_snippets": "Evidence of any other medical conditions (such as psychiatric illness, peptic ulcer, etc.)",
                    "criterion": "other medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "physical examination or laboratory findings that may interfere with the planned treatment",
                    "criterion": "physical examination or laboratory findings",
                    "requirements": [
                        {
                            "requirement_type": "interference with planned treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "physical examination or laboratory findings ... affect patient compliance",
                    "criterion": "physical examination or laboratory findings",
                    "requirements": [
                        {
                            "requirement_type": "affect on patient compliance",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "physical examination or laboratory findings ... place the patient at high risk from treatment-related complications",
                    "criterion": "physical examination or laboratory findings",
                    "requirements": [
                        {
                            "requirement_type": "risk from treatment-related complications",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "Patient related",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}