{
    "info": {
        "nct_id": "NCT00343720",
        "official_title": "A Randomized, Open-Label, Multicenter Study of Alimta® (Pemetrexed) Plus VELCADE® (Bortezomib) or Alimta Alone or VELCADE Alone in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Prior Antineoplastic Therapy",
        "inclusion_criteria": "* Men or women, 18 years of age or older\n* Non-small cell lung cancer (NSCLC) has been histologically or cytologically confirmed\n* Has relapsed or refractory locally advanced (Stage IIIb) or metastatic (Stage IV) NSCLC\n* Failed one prior line of systemic antineoplastic therapy for Stage IIIb/IV NSCLC (one additional prior line allowed if given as neoadjuvant, or adjuvant therapy to tumor resection)\n* Subject must have documented progressive disease (PD) since previous systemic antineoplastic therapy\n* Has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria\n* Has an ECOG performance status score of 0 or 1\n* Has a life expectancy greater than 3 months\n* Female subjects must be postmenopausal (for at least 6 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and have a negative serum or urine β-human chorionic gonadotropin (hCG) pregnancy test at screening.\n* Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to and able to comply with the protocol requirements and participate in the study before any study-related procedure not part of normal medical care is conducted.\n* In countries where health authorities have approved the pharmacogenomic and protein testing, subjects (or their legally acceptable representatives) must have signed an informed consent for testing indicating that they agree to participate in the genetic part and protein testing part of the study; participation in the genetic and protein testing component is mandatory for testing, but optional for future research.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Has peripheral neuropathy of Grade 2 or greater intensity, as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE Version 3.0)\n* Previous treatment with VELCADE or Alimta\n* Has received 2 or more prior lines of antineoplastic therapies for Stage IIIb/IV NSCLC\n* Any prior systemic antineoplastic therapy for NSCLC (i.e., prior chemotherapy, radiation therapy, prior monoclonal antibodies or any investigational drug or any major surgery) within 4 weeks before randomization\n* Has had significant weight loss (documented equal to or greater than 10% body weight in the 6 weeks before randomization)\n* Inadequate organ function at the screening visit as defined by the following laboratory values:\n\n  * Platelet count equal to or less than 100 × 10^9/L\n  * Hemoglobin equal to or less than 8.0 g/dL (80 g/L)\n  * Absolute neutrophil count (ANC) equal to or less than 1.5 × 10^9/L\n  * AST equal to or greater than 3 times the upper limit of the normal range (ULN) or greater than 5 times the ULN for subjects with liver metastases\n  * ALT equal to or greater than 3 times ULN\n  * Calculated creatinine clearance equal to or greater than 45 mL/min\n  * Total bilirubin equal to or greater than 1.5 times ULN\n* Myocardial infarction within 6 months before randomization or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities\n* Central nervous system metastasis or brain metastases that have not been completely resected or completely eliminated by radiation therapy and/or chemotherapy, or clinical or radiographic evidence that they have recurred. Subjects with a history of brain metastases are required to have had a brain computed tomography (CT) or magnetic resonance imaging (MRI) scan conducted within 1 month of enrollment to verify the continuing absence of brain metastases.\n* Uncontrolled pleural effusion (defined as more than 2 pleuracentesis within 4 weeks of the randomization)\n* Active systemic infection requiring treatment\n* Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) for a 5-day period (8-day period for long-acting agents, such as piroxicam)\n* Unable or unwilling to take corticosteroids\n* Other malignancy within the past 5 years. Exceptions for the following if treated and not active:\n\n  * basal cell or nonmetastatic squamous cell carcinoma of the skin;\n  * cervical carcinoma in situ; or\n  * International Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervix\n* History of allergic reaction attributable to compounds containing boron or mannitol\n* Is pregnant or breast-feeding\n* Currently enrolled in another clinical research study or has received an investigational agent for any reason within 4 weeks before randomization",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Men or women, 18 years of age or older",
                "criterions": [
                    {
                        "exact_snippets": "Men or women",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "18 years of age or older",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Men or women",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "18 years of age or older",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Non-small cell lung cancer (NSCLC) has been histologically or cytologically confirmed",
                "criterions": [
                    {
                        "exact_snippets": "Non-small cell lung cancer (NSCLC) has been histologically or cytologically confirmed",
                        "criterion": "non-small cell lung cancer (NSCLC)",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Non-small cell lung cancer (NSCLC) has been histologically or cytologically confirmed",
                        "criterion": "non-small cell lung cancer (NSCLC)",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has relapsed or refractory locally advanced (Stage IIIb) or metastatic (Stage IV) NSCLC",
                "criterions": [
                    {
                        "exact_snippets": "relapsed or refractory",
                        "criterion": "disease status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "relapsed",
                                "refractory"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "locally advanced (Stage IIIb)",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "Stage IIIb"
                        }
                    },
                    {
                        "exact_snippets": "metastatic (Stage IV)",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "Stage IV"
                        }
                    },
                    {
                        "exact_snippets": "NSCLC",
                        "criterion": "cancer type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "NSCLC"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "locally advanced (Stage IIIb)",
                                        "criterion": "cancer stage",
                                        "requirement": {
                                            "requirement_type": "stage",
                                            "expected_value": "Stage IIIb"
                                        }
                                    },
                                    {
                                        "exact_snippets": "metastatic (Stage IV)",
                                        "criterion": "cancer stage",
                                        "requirement": {
                                            "requirement_type": "stage",
                                            "expected_value": "Stage IV"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "NSCLC",
                                "criterion": "cancer type",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": "NSCLC"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "relapsed or refractory",
                        "criterion": "disease status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "relapsed",
                                "refractory"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Failed one prior line of systemic antineoplastic therapy for Stage IIIb/IV NSCLC (one additional prior line allowed if given as neoadjuvant, or adjuvant therapy to tumor resection)",
                "criterions": [
                    {
                        "exact_snippets": "Failed one prior line of systemic antineoplastic therapy",
                        "criterion": "prior systemic antineoplastic therapy",
                        "requirement": {
                            "requirement_type": "failure",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Failed one prior line of systemic antineoplastic therapy",
                        "criterion": "prior systemic antineoplastic therapy",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "line"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Stage IIIb/IV NSCLC",
                        "criterion": "NSCLC stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "IIIb",
                                "IV"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "one additional prior line allowed if given as neoadjuvant, or adjuvant therapy to tumor resection",
                        "criterion": "additional prior line of therapy",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "allowed if given as neoadjuvant, or adjuvant therapy to tumor resection"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Failed one prior line of systemic antineoplastic therapy",
                                "criterion": "prior systemic antineoplastic therapy",
                                "requirement": {
                                    "requirement_type": "failure",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Failed one prior line of systemic antineoplastic therapy",
                                "criterion": "prior systemic antineoplastic therapy",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": "=",
                                        "value": 1,
                                        "unit": "line"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Stage IIIb/IV NSCLC",
                        "criterion": "NSCLC stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "IIIb",
                                "IV"
                            ]
                        }
                    },
                    {
                        "condition": {
                            "exact_snippets": "one additional prior line allowed if given as neoadjuvant, or adjuvant therapy to tumor resection",
                            "criterion": "additional prior line of therapy",
                            "requirement": {
                                "requirement_type": "condition",
                                "expected_value": "allowed if given as neoadjuvant, or adjuvant therapy to tumor resection"
                            }
                        },
                        "then_criteria": null,
                        "else_criteria": null
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Subject must have documented progressive disease (PD) since previous systemic antineoplastic therapy",
                "criterions": [
                    {
                        "exact_snippets": "documented progressive disease (PD) since previous systemic antineoplastic therapy",
                        "criterion": "progressive disease",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "documented progressive disease (PD) since previous systemic antineoplastic therapy",
                        "criterion": "progressive disease",
                        "requirement": {
                            "requirement_type": "progression_since",
                            "expected_value": "previous systemic antineoplastic therapy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "documented progressive disease (PD) since previous systemic antineoplastic therapy",
                        "criterion": "progressive disease",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "documented progressive disease (PD) since previous systemic antineoplastic therapy",
                        "criterion": "progressive disease",
                        "requirement": {
                            "requirement_type": "progression_since",
                            "expected_value": "previous systemic antineoplastic therapy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria",
                "criterions": [
                    {
                        "exact_snippets": "Has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has a life expectancy greater than 3 months",
                "criterions": [
                    {
                        "exact_snippets": "life expectancy greater than 3 months",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "life expectancy greater than 3 months",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Female subjects must be postmenopausal (for at least 6 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and have a negative serum or urine β-human chorionic gonadotropin (hCG) pregnancy test at screening.",
                "criterions": [
                    {
                        "exact_snippets": "Female subjects",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "postmenopausal (for at least 6 months)",
                        "criterion": "menopausal status",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "surgically sterile",
                        "criterion": "surgical sterility",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "abstinent",
                        "criterion": "sexual activity",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "abstinent"
                        }
                    },
                    {
                        "exact_snippets": "sexually active, be practicing an effective method of birth control",
                        "criterion": "birth control method",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "effective method of birth control"
                        }
                    },
                    {
                        "exact_snippets": "negative serum or urine β-human chorionic gonadotropin (hCG) pregnancy test at screening",
                        "criterion": "pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Female subjects",
                                "criterion": "gender",
                                "requirement": {
                                    "requirement_type": "expected_value",
                                    "expected_value": "female"
                                }
                            },
                            {
                                "exact_snippets": "negative serum or urine β-human chorionic gonadotropin (hCG) pregnancy test at screening",
                                "criterion": "pregnancy test",
                                "requirement": {
                                    "requirement_type": "result",
                                    "expected_value": "negative"
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "postmenopausal (for at least 6 months)",
                                "criterion": "menopausal status",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "surgically sterile",
                                "criterion": "surgical sterility",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "abstinent",
                                "criterion": "sexual activity",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": "abstinent"
                                }
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "sexually active, be practicing an effective method of birth control",
                                        "criterion": "birth control method",
                                        "requirement": {
                                            "requirement_type": "status",
                                            "expected_value": "effective method of birth control"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to and able to comply with the protocol requirements and participate in the study before any study-related procedure not part of normal medical care is conducted.",
                "criterions": [
                    {
                        "exact_snippets": "Subjects (or their legally acceptable representatives) must have signed an informed consent document",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "indicating that they understand the purpose of and procedures required for the study",
                        "criterion": "understanding of study purpose and procedures",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willing to and able to comply with the protocol requirements",
                        "criterion": "compliance with protocol requirements",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "participate in the study",
                        "criterion": "participation in the study",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Subjects (or their legally acceptable representatives) must have signed an informed consent document",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "indicating that they understand the purpose of and procedures required for the study",
                        "criterion": "understanding of study purpose and procedures",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willing to and able to comply with the protocol requirements",
                        "criterion": "compliance with protocol requirements",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "participate in the study",
                        "criterion": "participation in the study",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* In countries where health authorities have approved the pharmacogenomic and protein testing, subjects (or their legally acceptable representatives) must have signed an informed consent for testing indicating that they agree to participate in the genetic part and protein testing part of the study; participation in the genetic and protein testing component is mandatory for testing, but optional for future research.",
                "criterions": [
                    {
                        "exact_snippets": "countries where health authorities have approved the pharmacogenomic and protein testing",
                        "criterion": "country approval for pharmacogenomic and protein testing",
                        "requirement": {
                            "requirement_type": "approval",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "subjects (or their legally acceptable representatives) must have signed an informed consent for testing",
                        "criterion": "informed consent for testing",
                        "requirement": {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "participation in the genetic and protein testing component is mandatory for testing",
                        "criterion": "participation in genetic and protein testing",
                        "requirement": {
                            "requirement_type": "mandatory",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "countries where health authorities have approved the pharmacogenomic and protein testing",
                    "criterion": "country approval for pharmacogenomic and protein testing",
                    "requirement": {
                        "requirement_type": "approval",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "subjects (or their legally acceptable representatives) must have signed an informed consent for testing",
                            "criterion": "informed consent for testing",
                            "requirement": {
                                "requirement_type": "signed",
                                "expected_value": true
                            }
                        },
                        {
                            "exact_snippets": "participation in the genetic and protein testing component is mandatory for testing",
                            "criterion": "participation in genetic and protein testing",
                            "requirement": {
                                "requirement_type": "mandatory",
                                "expected_value": true
                            }
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Has peripheral neuropathy of Grade 2 or greater intensity, as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE Version 3.0)",
                "criterions": [
                    {
                        "exact_snippets": "peripheral neuropathy of Grade 2 or greater intensity",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "peripheral neuropathy of Grade 2 or greater intensity",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Previous treatment with VELCADE or Alimta",
                "criterions": [
                    {
                        "exact_snippets": "Previous treatment with VELCADE",
                        "criterion": "previous treatment with VELCADE",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Previous treatment with ... Alimta",
                        "criterion": "previous treatment with Alimta",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Previous treatment with VELCADE",
                        "criterion": "previous treatment with VELCADE",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Previous treatment with ... Alimta",
                        "criterion": "previous treatment with Alimta",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has received 2 or more prior lines of antineoplastic therapies for Stage IIIb/IV NSCLC",
                "criterions": [
                    {
                        "exact_snippets": "2 or more prior lines of antineoplastic therapies",
                        "criterion": "prior lines of antineoplastic therapies",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "lines"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Stage IIIb/IV NSCLC",
                        "criterion": "NSCLC stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "IIIb",
                                "IV"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "2 or more prior lines of antineoplastic therapies",
                                "criterion": "prior lines of antineoplastic therapies",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "lines"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Stage IIIb/IV NSCLC",
                                "criterion": "NSCLC stage",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": [
                                        "IIIb",
                                        "IV"
                                    ]
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any prior systemic antineoplastic therapy for NSCLC (i.e., prior chemotherapy, radiation therapy, prior monoclonal antibodies or any investigational drug or any major surgery) within 4 weeks before randomization",
                "criterions": [
                    {
                        "exact_snippets": "Any prior systemic antineoplastic therapy for NSCLC",
                        "criterion": "prior systemic antineoplastic therapy for NSCLC",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "prior chemotherapy ... within 4 weeks before randomization",
                        "criterion": "prior chemotherapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "radiation therapy ... within 4 weeks before randomization",
                        "criterion": "radiation therapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "prior monoclonal antibodies ... within 4 weeks before randomization",
                        "criterion": "prior monoclonal antibodies",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "any investigational drug ... within 4 weeks before randomization",
                        "criterion": "investigational drug",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "any major surgery ... within 4 weeks before randomization",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "Any prior systemic antineoplastic therapy for NSCLC",
                            "criterion": "prior systemic antineoplastic therapy for NSCLC",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "prior chemotherapy ... within 4 weeks before randomization",
                                "criterion": "prior chemotherapy",
                                "requirement": {
                                    "requirement_type": "time since last treatment",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "radiation therapy ... within 4 weeks before randomization",
                                "criterion": "radiation therapy",
                                "requirement": {
                                    "requirement_type": "time since last treatment",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "prior monoclonal antibodies ... within 4 weeks before randomization",
                                "criterion": "prior monoclonal antibodies",
                                "requirement": {
                                    "requirement_type": "time since last treatment",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "any investigational drug ... within 4 weeks before randomization",
                                "criterion": "investigational drug",
                                "requirement": {
                                    "requirement_type": "time since last treatment",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "any major surgery ... within 4 weeks before randomization",
                                "criterion": "major surgery",
                                "requirement": {
                                    "requirement_type": "time since last treatment",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has had significant weight loss (documented equal to or greater than 10% body weight in the 6 weeks before randomization)",
                "criterions": [
                    {
                        "exact_snippets": "significant weight loss (documented equal to or greater than 10% body weight in the 6 weeks before randomization)",
                        "criterion": "weight loss",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "% body weight"
                            }
                        }
                    },
                    {
                        "exact_snippets": "significant weight loss (documented equal to or greater than 10% body weight in the 6 weeks before randomization)",
                        "criterion": "weight loss",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "6 weeks before randomization"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "significant weight loss (documented equal to or greater than 10% body weight in the 6 weeks before randomization)",
                                "criterion": "weight loss",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 10,
                                        "unit": "% body weight"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "significant weight loss (documented equal to or greater than 10% body weight in the 6 weeks before randomization)",
                                "criterion": "weight loss",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": "6 weeks before randomization"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Inadequate organ function at the screening visit as defined by the following laboratory values:",
                "criterions": [
                    {
                        "exact_snippets": "Inadequate organ function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Inadequate organ function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Platelet count equal to or less than 100 × 10^9/L",
                "criterions": [
                    {
                        "exact_snippets": "Platelet count equal to or less than 100 × 10^9/L",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 100,
                                "unit": "× 10^9/L"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Platelet count equal to or less than 100 × 10^9/L",
                    "criterion": "platelet count",
                    "requirement": {
                        "requirement_type": "quantity",
                        "expected_value": {
                            "operator": "<=",
                            "value": 100,
                            "unit": "× 10^9/L"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Hemoglobin equal to or less than 8.0 g/dL (80 g/L)",
                "criterions": [
                    {
                        "exact_snippets": "Hemoglobin equal to or less than 8.0 g/dL (80 g/L)",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 8.0,
                                        "unit": "g/dL"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hemoglobin equal to or less than 8.0 g/dL (80 g/L)",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 8.0,
                                        "unit": "g/dL"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Absolute neutrophil count (ANC) equal to or less than 1.5 × 10^9/L",
                "criterions": [
                    {
                        "exact_snippets": "Absolute neutrophil count (ANC) equal to or less than 1.5 × 10^9/L",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "× 10^9/L"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Absolute neutrophil count (ANC) equal to or less than 1.5 × 10^9/L",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "× 10^9/L"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* AST equal to or greater than 3 times the upper limit of the normal range (ULN) or greater than 5 times the ULN for subjects with liver metastases",
                "criterions": [
                    {
                        "exact_snippets": "AST equal to or greater than 3 times the upper limit of the normal range (ULN)",
                        "criterion": "AST level",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "times ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "AST ... greater than 5 times the ULN for subjects with liver metastases",
                        "criterion": "AST level with liver metastases",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "times ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "AST equal to or greater than 3 times the upper limit of the normal range (ULN)",
                                "criterion": "AST level",
                                "requirement": {
                                    "requirement_type": "comparison",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "times ULN"
                                    }
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "AST ... greater than 5 times the ULN for subjects with liver metastases",
                                    "criterion": "AST level with liver metastases",
                                    "requirement": {
                                        "requirement_type": "comparison",
                                        "expected_value": {
                                            "operator": ">",
                                            "value": 5,
                                            "unit": "times ULN"
                                        }
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "AST ... greater than 5 times the ULN for subjects with liver metastases",
                                "criterion": "AST level with liver metastases",
                                "requirement": {
                                    "requirement_type": "comparison",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 5,
                                        "unit": "times ULN"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* ALT equal to or greater than 3 times ULN",
                "criterions": [
                    {
                        "exact_snippets": "ALT equal to or greater than 3 times ULN",
                        "criterion": "ALT",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "times ULN"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "ALT equal to or greater than 3 times ULN",
                    "criterion": "ALT",
                    "requirement": {
                        "requirement_type": "level",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 3,
                                    "unit": "times ULN"
                                }
                            ]
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Calculated creatinine clearance equal to or greater than 45 mL/min",
                "criterions": [
                    {
                        "exact_snippets": "Calculated creatinine clearance equal to or greater than 45 mL/min",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 45,
                                        "unit": "mL/min"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Calculated creatinine clearance equal to or greater than 45 mL/min",
                    "criterion": "creatinine clearance",
                    "requirement": {
                        "requirement_type": "value",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 45,
                                    "unit": "mL/min"
                                }
                            ]
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Total bilirubin equal to or greater than 1.5 times ULN",
                "criterions": [
                    {
                        "exact_snippets": "Total bilirubin equal to or greater than 1.5 times ULN",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1.5,
                                        "unit": "times ULN"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Total bilirubin equal to or greater than 1.5 times ULN",
                    "criterion": "total bilirubin",
                    "requirement": {
                        "requirement_type": "level",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 1.5,
                                    "unit": "times ULN"
                                }
                            ]
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Myocardial infarction within 6 months before randomization or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities",
                "criterions": [
                    {
                        "exact_snippets": "Myocardial infarction within 6 months before randomization",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "New York Heart Association (NYHA) Class III or IV heart failure",
                        "criterion": "heart failure",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": [
                                "NYHA Class III",
                                "NYHA Class IV"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled angina",
                        "criterion": "angina",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    },
                    {
                        "exact_snippets": "severe uncontrolled arrhythmias",
                        "criterion": "arrhythmias",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "severe uncontrolled arrhythmias",
                        "criterion": "arrhythmias",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    },
                    {
                        "exact_snippets": "electrocardiographic evidence of acute ischemia",
                        "criterion": "acute ischemia",
                        "requirement": {
                            "requirement_type": "evidence",
                            "expected_value": "electrocardiographic"
                        }
                    },
                    {
                        "exact_snippets": "active conduction system abnormalities",
                        "criterion": "conduction system abnormalities",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Myocardial infarction within 6 months before randomization",
                                "criterion": "myocardial infarction",
                                "requirement": {
                                    "requirement_type": "time since event",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "New York Heart Association (NYHA) Class III or IV heart failure",
                                "criterion": "heart failure",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": [
                                        "NYHA Class III",
                                        "NYHA Class IV"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "uncontrolled angina",
                                "criterion": "angina",
                                "requirement": {
                                    "requirement_type": "control",
                                    "expected_value": "uncontrolled"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "severe uncontrolled arrhythmias",
                                "criterion": "arrhythmias",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "severe"
                                }
                            },
                            {
                                "exact_snippets": "severe uncontrolled arrhythmias",
                                "criterion": "arrhythmias",
                                "requirement": {
                                    "requirement_type": "control",
                                    "expected_value": "uncontrolled"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "electrocardiographic evidence of acute ischemia",
                                "criterion": "acute ischemia",
                                "requirement": {
                                    "requirement_type": "evidence",
                                    "expected_value": "electrocardiographic"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "active conduction system abnormalities",
                                "criterion": "conduction system abnormalities",
                                "requirement": {
                                    "requirement_type": "activity",
                                    "expected_value": "active"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Central nervous system metastasis or brain metastases that have not been completely resected or completely eliminated by radiation therapy and/or chemotherapy, or clinical or radiographic evidence that they have recurred. Subjects with a history of brain metastases are required to have had a brain computed tomography (CT) or magnetic resonance imaging (MRI) scan conducted within 1 month of enrollment to verify the continuing absence of brain metastases.",
                "criterions": [
                    {
                        "exact_snippets": "Central nervous system metastasis or brain metastases that have not been completely resected or completely eliminated by radiation therapy and/or chemotherapy",
                        "criterion": "central nervous system metastasis or brain metastases",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "completely resected or completely eliminated by radiation therapy and/or chemotherapy"
                        }
                    },
                    {
                        "exact_snippets": "clinical or radiographic evidence that they have recurred",
                        "criterion": "central nervous system metastasis or brain metastases",
                        "requirement": {
                            "requirement_type": "recurrence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Subjects with a history of brain metastases are required to have had a brain computed tomography (CT) or magnetic resonance imaging (MRI) scan conducted within 1 month of enrollment",
                        "criterion": "brain computed tomography (CT) or magnetic resonance imaging (MRI) scan",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    },
                    {
                        "exact_snippets": "to verify the continuing absence of brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "not_criteria": {
                                    "and_criteria": [
                                        {
                                            "exact_snippets": "Central nervous system metastasis or brain metastases that have not been completely resected or completely eliminated by radiation therapy and/or chemotherapy",
                                            "criterion": "central nervous system metastasis or brain metastases",
                                            "requirement": {
                                                "requirement_type": "treatment status",
                                                "expected_value": "completely resected or completely eliminated by radiation therapy and/or chemotherapy"
                                            }
                                        },
                                        {
                                            "exact_snippets": "clinical or radiographic evidence that they have recurred",
                                            "criterion": "central nervous system metastasis or brain metastases",
                                            "requirement": {
                                                "requirement_type": "recurrence",
                                                "expected_value": false
                                            }
                                        }
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "not_criteria": {
                                    "and_criteria": [
                                        {
                                            "exact_snippets": "Subjects with a history of brain metastases are required to have had a brain computed tomography (CT) or magnetic resonance imaging (MRI) scan conducted within 1 month of enrollment",
                                            "criterion": "brain computed tomography (CT) or magnetic resonance imaging (MRI) scan",
                                            "requirement": {
                                                "requirement_type": "timing",
                                                "expected_value": {
                                                    "operator": "<=",
                                                    "value": 1,
                                                    "unit": "month"
                                                }
                                            }
                                        },
                                        {
                                            "exact_snippets": "to verify the continuing absence of brain metastases",
                                            "criterion": "brain metastases",
                                            "requirement": {
                                                "requirement_type": "presence",
                                                "expected_value": false
                                            }
                                        }
                                    ]
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Uncontrolled pleural effusion (defined as more than 2 pleuracentesis within 4 weeks of the randomization)",
                "criterions": [
                    {
                        "exact_snippets": "Uncontrolled pleural effusion (defined as more than 2 pleuracentesis within 4 weeks of the randomization)",
                        "criterion": "pleural effusion",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled pleural effusion (defined as more than 2 pleuracentesis within 4 weeks of the randomization)",
                        "criterion": "pleural effusion",
                        "requirement": {
                            "requirement_type": "definition",
                            "expected_value": "more than 2 pleuracentesis within 4 weeks of the randomization"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Uncontrolled pleural effusion (defined as more than 2 pleuracentesis within 4 weeks of the randomization)",
                        "criterion": "pleural effusion",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled pleural effusion (defined as more than 2 pleuracentesis within 4 weeks of the randomization)",
                        "criterion": "pleural effusion",
                        "requirement": {
                            "requirement_type": "definition",
                            "expected_value": "more than 2 pleuracentesis within 4 weeks of the randomization"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Active systemic infection requiring treatment",
                "criterions": [
                    {
                        "exact_snippets": "Active systemic infection requiring treatment",
                        "criterion": "systemic infection",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "Active systemic infection requiring treatment",
                        "criterion": "systemic infection",
                        "requirement": {
                            "requirement_type": "treatment requirement",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Active systemic infection requiring treatment",
                        "criterion": "systemic infection",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "Active systemic infection requiring treatment",
                        "criterion": "systemic infection",
                        "requirement": {
                            "requirement_type": "treatment requirement",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) for a 5-day period (8-day period for long-acting agents, such as piroxicam)",
                "criterions": [
                    {
                        "exact_snippets": "Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) for a 5-day period",
                        "criterion": "ability to interrupt NSAIDs",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "(8-day period for long-acting agents, such as piroxicam)",
                        "criterion": "ability to interrupt long-acting NSAIDs",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) for a 5-day period",
                                "criterion": "ability to interrupt NSAIDs",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 5,
                                        "unit": "days"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "(8-day period for long-acting agents, such as piroxicam)",
                                "criterion": "ability to interrupt long-acting NSAIDs",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 8,
                                        "unit": "days"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Unable or unwilling to take corticosteroids",
                "criterions": [
                    {
                        "exact_snippets": "Unable or unwilling to take corticosteroids",
                        "criterion": "corticosteroid intake",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Unable or unwilling to take corticosteroids",
                        "criterion": "corticosteroid intake",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "Unable or unwilling to take corticosteroids",
                            "criterion": "corticosteroid intake",
                            "requirement": {
                                "requirement_type": "ability",
                                "expected_value": true
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "Unable or unwilling to take corticosteroids",
                            "criterion": "corticosteroid intake",
                            "requirement": {
                                "requirement_type": "willingness",
                                "expected_value": true
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Other malignancy within the past 5 years. Exceptions for the following if treated and not active:",
                "criterions": [
                    {
                        "exact_snippets": "Other malignancy within the past 5 years",
                        "criterion": "other malignancy",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Other malignancy within the past 5 years",
                    "criterion": "other malignancy",
                    "requirement": {
                        "requirement_type": "time frame",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": "<=",
                                    "value": 5,
                                    "unit": "years"
                                }
                            ]
                        }
                    }
                },
                "then_criteria": {
                    "not_criteria": {
                        "and_criteria": [
                            {
                                "exact_snippets": "Exceptions for the following if treated and not active",
                                "criterion": "other malignancy",
                                "requirement": {
                                    "requirement_type": "treatment status",
                                    "expected_value": "treated"
                                }
                            },
                            {
                                "exact_snippets": "Exceptions for the following if treated and not active",
                                "criterion": "other malignancy",
                                "requirement": {
                                    "requirement_type": "activity status",
                                    "expected_value": "not active"
                                }
                            }
                        ]
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* basal cell or nonmetastatic squamous cell carcinoma of the skin;",
                "criterions": [
                    {
                        "exact_snippets": "basal cell ... carcinoma of the skin",
                        "criterion": "basal cell carcinoma of the skin",
                        "requirement": {
                            "requirement_type": "metastasis",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "nonmetastatic squamous cell carcinoma of the skin",
                        "criterion": "squamous cell carcinoma of the skin",
                        "requirement": {
                            "requirement_type": "metastasis",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "basal cell ... carcinoma of the skin",
                        "criterion": "basal cell carcinoma of the skin",
                        "requirement": {
                            "requirement_type": "metastasis",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "nonmetastatic squamous cell carcinoma of the skin",
                        "criterion": "squamous cell carcinoma of the skin",
                        "requirement": {
                            "requirement_type": "metastasis",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* cervical carcinoma in situ; or",
                "criterions": [
                    {
                        "exact_snippets": "cervical carcinoma in situ",
                        "criterion": "cervical carcinoma",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "in situ"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "cervical carcinoma in situ",
                    "criterion": "cervical carcinoma",
                    "requirement": {
                        "requirement_type": "stage",
                        "expected_value": "in situ"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* International Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervix",
                "criterions": [
                    {
                        "exact_snippets": "International Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervix",
                        "criterion": "FIGO stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "1"
                        }
                    },
                    {
                        "exact_snippets": "carcinoma of the cervix",
                        "criterion": "cervical carcinoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "International Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervix",
                        "criterion": "FIGO stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "1"
                        }
                    },
                    {
                        "exact_snippets": "carcinoma of the cervix",
                        "criterion": "cervical carcinoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of allergic reaction attributable to compounds containing boron or mannitol",
                "criterions": [
                    {
                        "exact_snippets": "History of allergic reaction attributable to compounds containing boron",
                        "criterion": "allergic reaction to boron",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of allergic reaction attributable to compounds containing ... mannitol",
                        "criterion": "allergic reaction to mannitol",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "History of allergic reaction attributable to compounds containing boron",
                        "criterion": "allergic reaction to boron",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of allergic reaction attributable to compounds containing ... mannitol",
                        "criterion": "allergic reaction to mannitol",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Currently enrolled in another clinical research study or has received an investigational agent for any reason within 4 weeks before randomization",
                "criterions": [
                    {
                        "exact_snippets": "Currently enrolled in another clinical research study",
                        "criterion": "enrollment in another clinical research study",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "has received an investigational agent ... within 4 weeks before randomization",
                        "criterion": "receipt of investigational agent",
                        "requirement": {
                            "requirement_type": "time since receipt",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Currently enrolled in another clinical research study",
                        "criterion": "enrollment in another clinical research study",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "has received an investigational agent ... within 4 weeks before randomization",
                        "criterion": "receipt of investigational agent",
                        "requirement": {
                            "requirement_type": "time since receipt",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Has an ECOG performance status score of 0 or 1",
                "criterions": [
                    {
                        "exact_snippets": "ECOG performance status score of 0 or 1",
                        "criterion": "ECOG performance status score",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "ECOG performance status score of 0 or 1",
                        "criterion": "ECOG performance status score",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "0"
                        }
                    },
                    {
                        "exact_snippets": "ECOG performance status score of 0 or 1",
                        "criterion": "ECOG performance status score",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "1"
                        }
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Is pregnant or breast-feeding",
                "criterions": [
                    {
                        "exact_snippets": "Is pregnant",
                        "criterion": "pregnancy status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breast-feeding",
                        "criterion": "breastfeeding status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Is pregnant",
                        "criterion": "pregnancy status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "breast-feeding",
                        "criterion": "breastfeeding status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}