{
    "info": {
        "nct_id": "NCT00861120",
        "official_title": "Panitumumab and Pegylated Liposomal Doxorubicin for Platinum-Resistant Epithelial Ovarian Cancer With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-type",
        "inclusion_criteria": "* Histologically confirmed epithelial primary ovarian, primary fallopian or primary peritoneal cancer. Stage I-IV.\n\n  * A: First line treatment with a platinum containing regimen with either progression or no response during 1.line chemotherapy, or relapse within 6 months after end of 1. line chemotherapy, OR\n  * B: Patients receiving second line with a platinum containing regimen with either progression or no response during second line chemotherapy, or relapse within 6 months after end of second line chemotherapy\n* Maximum two prior lines of chemotherapy (both platinum-based)\n* Age ≥ 18 years.\n* Performance status 0-2.\n* Measurable disease by CA125 GCIG criteria\n* KRAS wild type\n* Adequate bone marrow function, liver function, renal function and coagulation parameters (within 7 days prior to randomization):\n\n  * WBC ≥ 3.0 x 109/l or neutrophils (ANC)≥ 1.5 x 109/l\n  * Platelet count ≥ 100 x 109/l\n  * Hemoglobin ≥ 9.7 g/dl (6 mmol/L)\n  * Serum bilirubin ≤ 1.5 x UNL\n  * Serum transaminases ≤ 2.5 x UNL in absence of liver metastases, or ≤ 5xUNL in presence of liver metastases\n  * Serum creatinine ≤ 1.5 x UNL\n  * Magnesium ≥ lower limit of normal\n  * Calcium ≥ lower limit of normal\n* Written informed consent\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Prior treatment with chemotherapy or biological targeted treatment except 1. line chemotherapy with platinum or combination platinum/taxane (bevacizumab allowed as part of the 1. line treatment).\n* Patients who have received (or are planning to receive) treatment with any other investigational agent, or who have participated in another clinical trial within 28 days prior to entering this trial.\n* Pregnant or breast-feeding or planning to become pregnant within 6 months after end of treatment. For fertile women a negative pregnancy test at screening is mandatory.\n* Fertile patients not willing to use acceptable and safe methods of contraception during and for 6 months following treatment\n* Other present or previous malignancy except curatively treated cervical cancer, non-melanotic skin cancer or other cancer with minimal risk of relapse.\n* CNS metastasis\n* History of any chronic medical or psychiatric condition or laboratory abnormality that are not medically controlled or in the opinion of the Investigator may increase the risks associated with study drug administration. (e.g. diabetes, cardiac diseases, hypertension).\n* Clinically significant cardiovascular disease ≤ 1 year before enrollment/randomization, including:\n\n  * Myocardial infarction or unstable angina within 6 months of randomization.\n  * New York Heart Association (NYHA) ≥ Grade 2 congestive heart failure. Even if medically controlled.\n  * Poorly controlled cardiac arrhythmia despite Medication (patients with rate-controlled atrial fibrillation are eligible)\n* Uncontrolled hypercalcemia (calcium level outside the upper limit of normal; antihypercalcemic treatment is allowed).\n* Allergy to the ingredients of the study medication or to Staphylococcus Protein A\n* History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically confirmed epithelial primary ovarian, primary fallopian or primary peritoneal cancer. Stage I-IV.",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed epithelial primary ovarian, primary fallopian or primary peritoneal cancer.",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "epithelial primary ovarian",
                                "primary fallopian",
                                "primary peritoneal"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Stage I-IV.",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "Stage"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "Stage"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A: First line treatment with a platinum containing regimen with either progression or no response during 1.line chemotherapy, or relapse within 6 months after end of 1. line chemotherapy, OR",
            "criterions": [
                {
                    "exact_snippets": "First line treatment with a platinum containing regimen",
                    "criterion": "first line treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "platinum containing regimen"
                        }
                    ]
                },
                {
                    "exact_snippets": "progression or no response during 1.line chemotherapy",
                    "criterion": "response to first line chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": [
                                "progression",
                                "no response"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "relapse within 6 months after end of 1. line chemotherapy",
                    "criterion": "relapse after first line chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* B: Patients receiving second line with a platinum containing regimen with either progression or no response during second line chemotherapy, or relapse within 6 months after end of second line chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Patients receiving second line with a platinum containing regimen",
                    "criterion": "second line platinum containing regimen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "progression or no response during second line chemotherapy",
                    "criterion": "response to second line chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": [
                                "progression",
                                "no response"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "relapse within 6 months after end of second line chemotherapy",
                    "criterion": "relapse after second line chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Maximum two prior lines of chemotherapy (both platinum-based)",
            "criterions": [
                {
                    "exact_snippets": "Maximum two prior lines of chemotherapy",
                    "criterion": "prior lines of chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "lines"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "both platinum-based",
                    "criterion": "prior chemotherapy type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "platinum-based"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age ≥ 18 years.",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Performance status 0-2.",
            "criterions": [
                {
                    "exact_snippets": "Performance status 0-2",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease by CA125 GCIG criteria",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease by CA125 GCIG criteria",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "criteria",
                            "expected_value": "CA125 GCIG"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* KRAS wild type",
            "criterions": [
                {
                    "exact_snippets": "KRAS wild type",
                    "criterion": "KRAS",
                    "requirements": [
                        {
                            "requirement_type": "mutation status",
                            "expected_value": "wild type"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WBC ≥ 3.0 x 109/l or neutrophils (ANC)≥ 1.5 x 109/l",
            "criterions": [
                {
                    "exact_snippets": "WBC ≥ 3.0 x 109/l",
                    "criterion": "WBC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3.0,
                                "unit": "x 109/l"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "neutrophils (ANC)≥ 1.5 x 109/l",
                    "criterion": "neutrophils (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 109/l"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count ≥ 100 x 109/l",
            "criterions": [
                {
                    "exact_snippets": "Platelet count ≥ 100 x 109/l",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 109/l"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin ≥ 9.7 g/dl (6 mmol/L)",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin ≥ 9.7 g/dl (6 mmol/L)",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9.7,
                                "unit": "g/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum bilirubin ≤ 1.5 x UNL",
            "criterions": [
                {
                    "exact_snippets": "Serum bilirubin ≤ 1.5 x UNL",
                    "criterion": "serum bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x UNL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum transaminases ≤ 2.5 x UNL in absence of liver metastases, or ≤ 5xUNL in presence of liver metastases",
            "criterions": [
                {
                    "exact_snippets": "Serum transaminases ≤ 2.5 x UNL in absence of liver metastases",
                    "criterion": "serum transaminases",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "x UNL"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "absence of liver metastases"
                        }
                    ]
                },
                {
                    "exact_snippets": "Serum transaminases ... ≤ 5xUNL in presence of liver metastases",
                    "criterion": "serum transaminases",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "x UNL"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "presence of liver metastases"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine ≤ 1.5 x UNL",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine ≤ 1.5 x UNL",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x UNL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Magnesium ≥ lower limit of normal",
            "criterions": [
                {
                    "exact_snippets": "Magnesium ≥ lower limit of normal",
                    "criterion": "magnesium level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">=",
                                "value": 0,
                                "unit": "lower limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Calcium ≥ lower limit of normal",
            "criterions": [
                {
                    "exact_snippets": "Calcium ≥ lower limit of normal",
                    "criterion": "calcium level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">=",
                                "value": 0,
                                "unit": "lower limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "form",
                            "expected_value": "written"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Prior treatment with chemotherapy or biological targeted treatment except 1. line chemotherapy with platinum or combination platinum/taxane (bevacizumab allowed as part of the 1. line treatment).",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with chemotherapy",
                    "criterion": "prior chemotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "biological targeted treatment",
                    "criterion": "prior biological targeted treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "1. line chemotherapy with platinum",
                    "criterion": "1st line chemotherapy with platinum",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "combination platinum/taxane",
                    "criterion": "combination platinum/taxane treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "bevacizumab allowed as part of the 1. line treatment",
                    "criterion": "bevacizumab as part of 1st line treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have received (or are planning to receive) treatment with any other investigational agent, or who have participated in another clinical trial within 28 days prior to entering this trial.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have received (or are planning to receive) treatment with any other investigational agent",
                    "criterion": "treatment with investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "who have participated in another clinical trial within 28 days prior to entering this trial",
                    "criterion": "participation in another clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "time since participation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or breast-feeding or planning to become pregnant within 6 months after end of treatment. For fertile women a negative pregnancy test at screening is mandatory.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding",
                    "criterion": "breastfeeding status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "planning to become pregnant within 6 months after end of treatment",
                    "criterion": "pregnancy planning",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "not within 6 months after end of treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "fertile women ... negative pregnancy test at screening is mandatory",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fertile patients not willing to use acceptable and safe methods of contraception during and for 6 months following treatment",
            "criterions": [
                {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    ]
                },
                {
                    "exact_snippets": "not willing to use acceptable and safe methods of contraception",
                    "criterion": "contraception willingness",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "during and for 6 months following treatment",
                    "criterion": "contraception duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during and for 6 months following treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other present or previous malignancy except curatively treated cervical cancer, non-melanotic skin cancer or other cancer with minimal risk of relapse.",
            "criterions": [
                {
                    "exact_snippets": "Other present or previous malignancy",
                    "criterion": "other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except curatively treated cervical cancer",
                    "criterion": "curatively treated cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... non-melanotic skin cancer",
                    "criterion": "non-melanotic skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... other cancer with minimal risk of relapse",
                    "criterion": "other cancer with minimal risk of relapse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* CNS metastasis",
            "criterions": [
                {
                    "exact_snippets": "CNS metastasis",
                    "criterion": "CNS metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of any chronic medical or psychiatric condition or laboratory abnormality that are not medically controlled or in the opinion of the Investigator may increase the risks associated with study drug administration. (e.g. diabetes, cardiac diseases, hypertension).",
            "criterions": [
                {
                    "exact_snippets": "History of any chronic medical or psychiatric condition",
                    "criterion": "chronic medical or psychiatric condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "laboratory abnormality",
                    "criterion": "laboratory abnormality",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "not medically controlled",
                    "criterion": "medical control",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "not controlled"
                        }
                    ]
                },
                {
                    "exact_snippets": "in the opinion of the Investigator may increase the risks associated with study drug administration",
                    "criterion": "investigator's opinion on risk",
                    "requirements": [
                        {
                            "requirement_type": "risk assessment",
                            "expected_value": "may increase risks"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant cardiovascular disease ≤ 1 year before enrollment/randomization, including:",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant cardiovascular disease ≤ 1 year before enrollment/randomization",
                    "criterion": "clinically significant cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "time since diagnosis",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Myocardial infarction or unstable angina within 6 months of randomization.",
            "criterions": [
                {
                    "exact_snippets": "Myocardial infarction ... within 6 months of randomization.",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina within 6 months of randomization.",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* New York Heart Association (NYHA) ≥ Grade 2 congestive heart failure. Even if medically controlled.",
            "criterions": [
                {
                    "exact_snippets": "New York Heart Association (NYHA) ≥ Grade 2 congestive heart failure",
                    "criterion": "New York Heart Association (NYHA) grade",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Poorly controlled cardiac arrhythmia despite Medication (patients with rate-controlled atrial fibrillation are eligible)",
            "criterions": [
                {
                    "exact_snippets": "Poorly controlled cardiac arrhythmia despite Medication",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "rate-controlled atrial fibrillation",
                    "criterion": "atrial fibrillation",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled hypercalcemia (calcium level outside the upper limit of normal; antihypercalcemic treatment is allowed).",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled hypercalcemia (calcium level outside the upper limit of normal",
                    "criterion": "calcium level",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "range",
                            "expected_value": "outside the upper limit of normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Allergy to the ingredients of the study medication or to Staphylococcus Protein A",
            "criterions": [
                {
                    "exact_snippets": "Allergy to the ingredients of the study medication",
                    "criterion": "allergy to study medication ingredients",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Allergy ... to Staphylococcus Protein A",
                    "criterion": "allergy to Staphylococcus Protein A",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.",
            "criterions": [
                {
                    "exact_snippets": "History of interstitial pneumonitis",
                    "criterion": "interstitial pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... pulmonary fibrosis",
                    "criterion": "pulmonary fibrosis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of interstitial lung disease on baseline chest CT scan",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "evidence on baseline chest CT scan",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Adequate bone marrow function, liver function, renal function and coagulation parameters (within 7 days prior to randomization):",
            "criterions": [
                {
                    "exact_snippets": "Adequate bone marrow function",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "adequate"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... liver function",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "adequate"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "adequate"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... coagulation parameters",
                    "criterion": "coagulation parameters",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "adequate"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}