{
    "info": {
        "nct_id": "NCT00023972",
        "official_title": "A Randomized, Open-Label, Multicenter Phase III Study Comparing the Efficacy and Safety of a Combination of Intravenous DX-8951f (Exatecan Mesylate) Plus Gemcitabine to Gemcitabine Alone in Patients With Locally Advanced or Metastatic Cancer of the Exocrine Pancreas Who Have Not Received Prior Chemotherapy",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed epithelial cancer of the exocrine pancreas\n\n  * Locally advanced (unresectable) or metastatic disease\n* No islet cell tumor, lymphoma, or sarcoma of the pancreas\n* No known brain metastases\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* Karnofsky 60-100%\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Absolute neutrophil count at least 1,500/mm3\n* Platelet count at least 100,000/mm3\n\nHepatic:\n\n* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\n* AST no greater than 5 times ULN\n* Albumin at least 2.8 g/dL\n\nRenal:\n\n* Creatinine no greater than 1.5 times ULN\n\nCardiovascular:\n\n* No active congestive heart failure\n* No uncontrolled angina\n* No myocardial infarction\n\nOther:\n\n* No serious infection or life-threatening illness unrelated to tumor\n* No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix\n* No overt psychosis or incompetency that would preclude study\n* No history of a positive serology for HIV\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No prior systemic anticancer immunotherapy for pancreatic cancer\n* No concurrent anticancer immunotherapy or other biologic therapy\n\nChemotherapy:\n\n* No prior systemic anticancer chemotherapy for pancreatic cancer\n* Prior fluorouracil as a radiosensitizer allowed\n* No prior gemcitabine as a radiosensitizer\n* No other concurrent anticancer chemotherapy\n\nEndocrine therapy:\n\n* Concurrent megestrol for appetite stimulation allowed\n\nRadiotherapy:\n\n* At least 28 days since prior radiotherapy and recovered\n* No prior radiotherapy to more than 25% of estimated bone marrow reserve\n* No concurrent anticancer radiotherapy\n\nSurgery:\n\n* At least 28 days since prior major surgery and recovered\n* No concurrent surgery for cancer\n\nOther:\n\n* No prior investigational or other systemic anticancer therapy for pancreatic cancer\n* No other concurrent investigational drugs"
    },
    "inclusion_lines": [
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "DISEASE CHARACTERISTICS:",
            "criterions": [
                {
                    "exact_snippets": "DISEASE CHARACTERISTICS",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically or cytologically confirmed epithelial cancer of the exocrine pancreas",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed epithelial cancer of the exocrine pancreas",
                    "criterion": "epithelial cancer of the exocrine pancreas",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Locally advanced (unresectable) or metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "Locally advanced (unresectable)",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "locally advanced"
                        },
                        {
                            "requirement_type": "resectability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "metastatic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No islet cell tumor, lymphoma, or sarcoma of the pancreas",
            "criterions": [
                {
                    "exact_snippets": "No islet cell tumor",
                    "criterion": "islet cell tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... lymphoma ... of the pancreas",
                    "criterion": "pancreatic lymphoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... sarcoma of the pancreas",
                    "criterion": "pancreatic sarcoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No known brain metastases",
            "criterions": [
                {
                    "exact_snippets": "No known brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Age:",
            "criterions": [
                {
                    "exact_snippets": "Age:",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 18 and over",
            "criterions": [
                {
                    "exact_snippets": "18 and over",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Performance status:",
            "criterions": [
                {
                    "exact_snippets": "Performance status:",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Karnofsky 60-100%",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky 60-100%",
                    "criterion": "Karnofsky performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 60,
                                        "unit": "%"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 100,
                                        "unit": "%"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Life expectancy:",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hematopoietic:",
            "criterions": [
                {
                    "exact_snippets": "Hematopoietic:",
                    "criterion": "hematopoietic system",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count at least 1,500/mm3",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count at least 1,500/mm3",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count at least 100,000/mm3",
            "criterions": [
                {
                    "exact_snippets": "Platelet count at least 100,000/mm3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hepatic:",
            "criterions": [
                {
                    "exact_snippets": "Hepatic:",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin no greater than 1.5 times upper limit of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin no greater than 1.5 times upper limit of normal (ULN)",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST no greater than 5 times ULN",
            "criterions": [
                {
                    "exact_snippets": "AST no greater than 5 times ULN",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Albumin at least 2.8 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Albumin at least 2.8 g/dL",
                    "criterion": "albumin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2.8,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Renal:",
            "criterions": [
                {
                    "exact_snippets": "Renal:",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine no greater than 1.5 times ULN",
            "criterions": [
                {
                    "exact_snippets": "Creatinine no greater than 1.5 times ULN",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Cardiovascular:",
            "criterions": [
                {
                    "exact_snippets": "Cardiovascular:",
                    "criterion": "cardiovascular",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No active congestive heart failure",
            "criterions": [
                {
                    "exact_snippets": "No active congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No uncontrolled angina",
            "criterions": [
                {
                    "exact_snippets": "No uncontrolled angina",
                    "criterion": "uncontrolled angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No myocardial infarction",
            "criterions": [
                {
                    "exact_snippets": "No myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No serious infection or life-threatening illness unrelated to tumor",
            "criterions": [
                {
                    "exact_snippets": "No serious infection",
                    "criterion": "serious infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... life-threatening illness unrelated to tumor",
                    "criterion": "life-threatening illness unrelated to tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix",
            "criterions": [
                {
                    "exact_snippets": "No other malignancy within the past 2 years",
                    "criterion": "other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time since last occurrence",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except nonmelanoma skin cancer",
                    "criterion": "nonmelanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... carcinoma in situ of the cervix",
                    "criterion": "carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No overt psychosis or incompetency that would preclude study",
            "criterions": [
                {
                    "exact_snippets": "No overt psychosis",
                    "criterion": "psychosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "incompetency that would preclude study",
                    "criterion": "incompetency",
                    "requirements": [
                        {
                            "requirement_type": "impact on study participation",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of a positive serology for HIV",
            "criterions": [
                {
                    "exact_snippets": "No history of a positive serology for HIV",
                    "criterion": "HIV serology",
                    "requirements": [
                        {
                            "requirement_type": "history of positive result",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Negative pregnancy test",
            "criterions": [
                {
                    "exact_snippets": "Negative pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fertile patients must use contraception",
            "criterions": [
                {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    ]
                },
                {
                    "exact_snippets": "must use contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY:",
            "criterions": [
                {
                    "exact_snippets": "PRIOR CONCURRENT THERAPY",
                    "criterion": "prior concurrent therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Biologic therapy:",
            "criterions": [
                {
                    "exact_snippets": "Biologic therapy",
                    "criterion": "biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior systemic anticancer immunotherapy for pancreatic cancer",
            "criterions": [
                {
                    "exact_snippets": "No prior systemic anticancer immunotherapy for pancreatic cancer",
                    "criterion": "prior systemic anticancer immunotherapy for pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent anticancer immunotherapy or other biologic therapy",
            "criterions": [
                {
                    "exact_snippets": "No concurrent anticancer immunotherapy",
                    "criterion": "anticancer immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No concurrent ... other biologic therapy",
                    "criterion": "biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Chemotherapy:",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior systemic anticancer chemotherapy for pancreatic cancer",
            "criterions": [
                {
                    "exact_snippets": "No prior systemic anticancer chemotherapy for pancreatic cancer",
                    "criterion": "prior systemic anticancer chemotherapy for pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior fluorouracil as a radiosensitizer allowed",
            "criterions": [
                {
                    "exact_snippets": "Prior fluorouracil as a radiosensitizer allowed",
                    "criterion": "prior fluorouracil use",
                    "requirements": [
                        {
                            "requirement_type": "use as",
                            "expected_value": "radiosensitizer"
                        },
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior gemcitabine as a radiosensitizer",
            "criterions": [
                {
                    "exact_snippets": "No prior gemcitabine as a radiosensitizer",
                    "criterion": "prior gemcitabine as a radiosensitizer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent anticancer chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent anticancer chemotherapy",
                    "criterion": "concurrent anticancer chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Endocrine therapy:",
            "criterions": [
                {
                    "exact_snippets": "Endocrine therapy",
                    "criterion": "endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent megestrol for appetite stimulation allowed",
            "criterions": [
                {
                    "exact_snippets": "Concurrent megestrol for appetite stimulation allowed",
                    "criterion": "concurrent megestrol",
                    "requirements": [
                        {
                            "requirement_type": "purpose",
                            "expected_value": "appetite stimulation"
                        },
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Radiotherapy:",
            "criterions": [
                {
                    "exact_snippets": "Radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 28 days since prior radiotherapy and recovered",
            "criterions": [
                {
                    "exact_snippets": "At least 28 days since prior radiotherapy",
                    "criterion": "time since prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "recovered",
                    "criterion": "recovery from prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "recovered"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior radiotherapy to more than 25% of estimated bone marrow reserve",
            "criterions": [
                {
                    "exact_snippets": "No prior radiotherapy to more than 25% of estimated bone marrow reserve",
                    "criterion": "prior radiotherapy to bone marrow reserve",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 25,
                                "unit": "% of estimated bone marrow reserve"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent anticancer radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "No concurrent anticancer radiotherapy",
                    "criterion": "anticancer radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Surgery:",
            "criterions": [
                {
                    "exact_snippets": "Surgery",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 28 days since prior major surgery and recovered",
            "criterions": [
                {
                    "exact_snippets": "At least 28 days since prior major surgery",
                    "criterion": "time since prior major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "recovered",
                    "criterion": "recovery from prior major surgery",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent surgery for cancer",
            "criterions": [
                {
                    "exact_snippets": "No concurrent surgery for cancer",
                    "criterion": "concurrent surgery for cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior investigational or other systemic anticancer therapy for pancreatic cancer",
            "criterions": [
                {
                    "exact_snippets": "No prior investigational or other systemic anticancer therapy for pancreatic cancer",
                    "criterion": "prior investigational or other systemic anticancer therapy for pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent investigational drugs",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent investigational drugs",
                    "criterion": "concurrent investigational drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "Other:",
            "criterions": [
                {
                    "exact_snippets": "Tissue from tumor must be available",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Tissue from tumor ... > 2 cm in diameter.",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Not pregnant or nursing",
            "criterions": [
                {
                    "exact_snippets": "Not pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not ... nursing",
                    "criterion": "nursing status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Other:",
            "criterions": []
        }
    ]
}