{
    "info": {
        "nct_id": "NCT01426620",
        "official_title": "Salvage Therapy With Docetaxel and Blueberry Powder in Non-Small Cell Lung Cancer",
        "inclusion_criteria": "1. Provide written informed consent prior to screening\n2. Male or female patients, age ≥ 18 years\n3. Histologically or cytologically confirmed diagnosis of NSCLC\n4. Stage IV disease (including patients with pleural effusion previously classified as Stage IIIB)\n5. All of the following if patient has had prior radiation therapy:\n\n   * lesion(s) used for determination of response were not previously irradiated or have increased in size since the completion of radiotherapy\n   * the patient has recovered from any acute effects of the radiotherapy\n   * radiotherapy was completed at least 4 weeks prior to screening\n6. Part 1: Have at least non-measurable evaluable disease (e.g., lesions which are smaller than the minimum size required for measurability; other non-measurable lesions such as bone metastases, malignant pleural effusion)\n7. Part 2: Have measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) as > 10 millimeters (mm) on cross-sectional imaging (where the CT slice thickness is no greater than 5 mm) or at least 20 mm by standard techniques; positron emissions tomography [PET] and ultrasound are not permitted methods for tumor measurements under this protocol.\n8. Performance status of 0 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale\n9. Have an estimated life expectancy of at least 12 weeks\n10. Adequate organ function within 14 days prior to first berry powder dose or docetaxel whichever occurs first, including the following - absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, hemoglobin ≥ 9 g/dL (≥ 5.6 mmol/L), patients may receive packed red blood cells (RBC) transfusion to achieve this level at the discretion of the investigator, total bilirubin < 1.5 x upper limit of normal (ULN) unless elevated secondary to conditions such as Gilbert's Disease, aspartate aminotransferase (AST) < 3 x ULN (< 5 x ULN in the presence of hepatic metastases), alanine aminotransferase (ALT) < 3 x ULN (< 5 x ULN in the presence of hepatic metastases), alkaline phosphatase < 3.0 x ULN, calculated creatinine clearance ≥ 60 mL/min per Cockcroft and Gault formula\n11. Satisfy one of the following:\n\n    * Females: non-pregnant and non-lactating; surgically sterile, post-menopausal, or patient/partner compliant with a reliable contraceptive regimen, as determined by the Investigator, for 4 weeks prior to screening. Patients of reproductive potential must test negative for pregnancy at screening and must agree to use a reliable method of birth control during the study period\n    * Males: surgically sterile or patient/partner must agree to use a reliable contraceptive method, as determined by the Investigator, during the study period\n    * The patient is willing and able to comply with the study visit schedule and procedures, and has geographical proximity (Investigator's discretion) that allows follow-up specified by the protocol\n    * For Part 1: have discontinued all prior chemotherapies, biological therapies, and other investigational therapies for cancer for at least 4 weeks (6 weeks for mitomycin-C or nitrosoureas) prior to study treatment and have recovered from the acute effects of therapy\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Part 1: More than one prior chemotherapy (single biological therapy, i.e., Erlotinib not included) regimens (approved or experimental) for NSCLC, not counting adjuvant and neoadjuvant treatment. A regimen is defined as two or more consecutive cycles of treatment. Part 2: Any prior chemotherapy or biological therapy (approved or experimental) for NSCLC including adjuvant and neoadjuvant treatments\n2. Treatment with another investigational drug, biological agent, or device within 4 weeks (6 weeks for biological agents) before screening or 5 half-lives of study agent, whichever is longer\n3. Patients with treated or untreated parenchymal brain metastases or leptomeningeal disease. Brain imaging is required for symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients\n4. Patients with known pericardial effusion\n5. Patients with active infection or serious concomitant systemic disorder (for example, heart failure) incompatible with the study (at the discretion of the Investigator)\n6. Presence or history of malignancy other than NSCLC, carcinoma in situ of the cervix, or non-melanoma skin cancer. In the case of other malignancies, patients may be considered for participation if the prior malignancies were diagnosed and definitively treated at least two years previously with no subsequent evidence of recurrence.\n7. Presence of an underlying disease state associated with active bleeding\n8. Concurrent treatment with other anticancer drugs\n9. Pre-existing peripheral neuropathy ≥ Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE) Grade 2\n10. Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device\n11. Patients with any other medical conditions that in the opinion of the Investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in or completing the study\n12. Allergy to berries",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. Provide written informed consent prior to screening",
                "criterions": [
                    {
                        "exact_snippets": "written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Male or female patients, age ≥ 18 years",
                "criterions": [
                    {
                        "exact_snippets": "Male or female patients",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "age ≥ 18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Male or female patients",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "age ≥ 18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Histologically or cytologically confirmed diagnosis of NSCLC",
                "criterions": [
                    {
                        "exact_snippets": "Histologically or cytologically confirmed diagnosis of NSCLC",
                        "criterion": "NSCLC diagnosis",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Histologically or cytologically confirmed diagnosis of NSCLC",
                        "criterion": "NSCLC diagnosis",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Stage IV disease (including patients with pleural effusion previously classified as Stage IIIB)",
                "criterions": [
                    {
                        "exact_snippets": "Stage IV disease",
                        "criterion": "disease stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        }
                    },
                    {
                        "exact_snippets": "pleural effusion previously classified as Stage IIIB",
                        "criterion": "pleural effusion",
                        "requirement": {
                            "requirement_type": "stage classification",
                            "expected_value": "Stage IIIB"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Stage IV disease",
                        "criterion": "disease stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        }
                    },
                    {
                        "exact_snippets": "pleural effusion previously classified as Stage IIIB",
                        "criterion": "pleural effusion",
                        "requirement": {
                            "requirement_type": "stage classification",
                            "expected_value": "Stage IIIB"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. All of the following if patient has had prior radiation therapy:",
                "criterions": [
                    {
                        "exact_snippets": "prior radiation therapy",
                        "criterion": "prior radiation therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "prior radiation therapy",
                    "criterion": "prior radiation therapy",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "then_criteria": null,
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* lesion(s) used for determination of response were not previously irradiated or have increased in size since the completion of radiotherapy",
                "criterions": [
                    {
                        "exact_snippets": "lesion(s) used for determination of response were not previously irradiated",
                        "criterion": "lesion irradiation status",
                        "requirement": {
                            "requirement_type": "irradiation status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "lesion(s) ... have increased in size since the completion of radiotherapy",
                        "criterion": "lesion size change post-radiotherapy",
                        "requirement": {
                            "requirement_type": "size change",
                            "expected_value": "increased"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "lesion(s) used for determination of response were not previously irradiated",
                                "criterion": "lesion irradiation status",
                                "requirement": {
                                    "requirement_type": "irradiation status",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "lesion(s) ... have increased in size since the completion of radiotherapy",
                                "criterion": "lesion size change post-radiotherapy",
                                "requirement": {
                                    "requirement_type": "size change",
                                    "expected_value": "increased"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* the patient has recovered from any acute effects of the radiotherapy",
                "criterions": [
                    {
                        "exact_snippets": "the patient has recovered from any acute effects of the radiotherapy",
                        "criterion": "recovery from acute effects of radiotherapy",
                        "requirement": {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "the patient has recovered from any acute effects of the radiotherapy",
                        "criterion": "recovery from acute effects of radiotherapy",
                        "requirement": {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* radiotherapy was completed at least 4 weeks prior to screening",
                "criterions": [
                    {
                        "exact_snippets": "radiotherapy was completed at least 4 weeks prior to screening",
                        "criterion": "radiotherapy completion",
                        "requirement": {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "radiotherapy was completed at least 4 weeks prior to screening",
                        "criterion": "radiotherapy completion",
                        "requirement": {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Part 1: Have at least non-measurable evaluable disease (e.g., lesions which are smaller than the minimum size required for measurability; other non-measurable lesions such as bone metastases, malignant pleural effusion)",
                "criterions": [
                    {
                        "exact_snippets": "non-measurable evaluable disease",
                        "criterion": "evaluable disease",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "lesions which are smaller than the minimum size required for measurability",
                        "criterion": "lesion size",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": "smaller than the minimum size required for measurability"
                        }
                    },
                    {
                        "exact_snippets": "non-measurable lesions such as bone metastases",
                        "criterion": "bone metastases",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "non-measurable lesions such as ... malignant pleural effusion",
                        "criterion": "malignant pleural effusion",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "non-measurable evaluable disease",
                                "criterion": "evaluable disease",
                                "requirement": {
                                    "requirement_type": "measurability",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "lesions which are smaller than the minimum size required for measurability",
                                "criterion": "lesion size",
                                "requirement": {
                                    "requirement_type": "size",
                                    "expected_value": "smaller than the minimum size required for measurability"
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "non-measurable lesions such as bone metastases",
                                "criterion": "bone metastases",
                                "requirement": {
                                    "requirement_type": "measurability",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "non-measurable lesions such as ... malignant pleural effusion",
                                "criterion": "malignant pleural effusion",
                                "requirement": {
                                    "requirement_type": "measurability",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Performance status of 0 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale",
                "criterions": [
                    {
                        "exact_snippets": "Performance status of 0 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale",
                        "criterion": "ECOG Performance Status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "2"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Performance status of 0 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale",
                        "criterion": "ECOG Performance Status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "2"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. Have an estimated life expectancy of at least 12 weeks",
                "criterions": [
                    {
                        "exact_snippets": "life expectancy of at least 12 weeks",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "life expectancy of at least 12 weeks",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "10. Adequate organ function within 14 days prior to first berry powder dose or docetaxel whichever occurs first, including the following - absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, hemoglobin ≥ 9 g/dL (≥ 5.6 mmol/L), patients may receive packed red blood cells (RBC) transfusion to achieve this level at the discretion of the investigator, total bilirubin < 1.5 x upper limit of normal (ULN) unless elevated secondary to conditions such as Gilbert's Disease, aspartate aminotransferase (AST) < 3 x ULN (< 5 x ULN in the presence of hepatic metastases), alanine aminotransferase (ALT) < 3 x ULN (< 5 x ULN in the presence of hepatic metastases), alkaline phosphatase < 3.0 x ULN, calculated creatinine clearance ≥ 60 mL/min per Cockcroft and Gault formula",
                "criterions": [
                    {
                        "exact_snippets": "absolute neutrophil count (ANC) ≥ 1.5 x 109/L",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 109/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "platelet count ≥ 100 x 109/L",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 109/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "hemoglobin ≥ 9 g/dL (≥ 5.6 mmol/L)",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "total bilirubin < 1.5 x upper limit of normal (ULN)",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "aspartate aminotransferase (AST) < 3 x ULN (< 5 x ULN in the presence of hepatic metastases)",
                        "criterion": "aspartate aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 3,
                                        "unit": "x ULN"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 5,
                                        "unit": "x ULN in the presence of hepatic metastases"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "alanine aminotransferase (ALT) < 3 x ULN (< 5 x ULN in the presence of hepatic metastases)",
                        "criterion": "alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 3,
                                        "unit": "x ULN"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 5,
                                        "unit": "x ULN in the presence of hepatic metastases"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "alkaline phosphatase < 3.0 x ULN",
                        "criterion": "alkaline phosphatase",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 3.0,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "calculated creatinine clearance ≥ 60 mL/min per Cockcroft and Gault formula",
                        "criterion": "calculated creatinine clearance",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min per Cockcroft and Gault formula"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "and_criteria": [
                                                    {
                                                        "and_criteria": [
                                                            {
                                                                "and_criteria": [
                                                                    {
                                                                        "and_criteria": [
                                                                            {
                                                                                "exact_snippets": "absolute neutrophil count (ANC) ≥ 1.5 x 109/L",
                                                                                "criterion": "absolute neutrophil count (ANC)",
                                                                                "requirement": {
                                                                                    "requirement_type": "quantity",
                                                                                    "expected_value": {
                                                                                        "operator": ">=",
                                                                                        "value": 1.5,
                                                                                        "unit": "x 109/L"
                                                                                    }
                                                                                }
                                                                            },
                                                                            {
                                                                                "exact_snippets": "platelet count ≥ 100 x 109/L",
                                                                                "criterion": "platelet count",
                                                                                "requirement": {
                                                                                    "requirement_type": "quantity",
                                                                                    "expected_value": {
                                                                                        "operator": ">=",
                                                                                        "value": 100,
                                                                                        "unit": "x 109/L"
                                                                                    }
                                                                                }
                                                                            }
                                                                        ]
                                                                    },
                                                                    {
                                                                        "exact_snippets": "hemoglobin ≥ 9 g/dL (≥ 5.6 mmol/L)",
                                                                        "criterion": "hemoglobin",
                                                                        "requirement": {
                                                                            "requirement_type": "quantity",
                                                                            "expected_value": {
                                                                                "operator": ">=",
                                                                                "value": 9,
                                                                                "unit": "g/dL"
                                                                            }
                                                                        }
                                                                    }
                                                                ]
                                                            },
                                                            {
                                                                "exact_snippets": "total bilirubin < 1.5 x upper limit of normal (ULN)",
                                                                "criterion": "total bilirubin",
                                                                "requirement": {
                                                                    "requirement_type": "quantity",
                                                                    "expected_value": {
                                                                        "operator": "<",
                                                                        "value": 1.5,
                                                                        "unit": "x ULN"
                                                                    }
                                                                }
                                                            }
                                                        ]
                                                    },
                                                    {
                                                        "exact_snippets": "aspartate aminotransferase (AST) < 3 x ULN (< 5 x ULN in the presence of hepatic metastases)",
                                                        "criterion": "aspartate aminotransferase (AST)",
                                                        "requirement": {
                                                            "requirement_type": "quantity",
                                                            "expected_value": {
                                                                "comparisons": [
                                                                    {
                                                                        "operator": "<",
                                                                        "value": 3,
                                                                        "unit": "x ULN"
                                                                    },
                                                                    {
                                                                        "operator": "<",
                                                                        "value": 5,
                                                                        "unit": "x ULN in the presence of hepatic metastases"
                                                                    }
                                                                ]
                                                            }
                                                        }
                                                    }
                                                ]
                                            },
                                            {
                                                "exact_snippets": "alanine aminotransferase (ALT) < 3 x ULN (< 5 x ULN in the presence of hepatic metastases)",
                                                "criterion": "alanine aminotransferase (ALT)",
                                                "requirement": {
                                                    "requirement_type": "quantity",
                                                    "expected_value": {
                                                        "comparisons": [
                                                            {
                                                                "operator": "<",
                                                                "value": 3,
                                                                "unit": "x ULN"
                                                            },
                                                            {
                                                                "operator": "<",
                                                                "value": 5,
                                                                "unit": "x ULN in the presence of hepatic metastases"
                                                            }
                                                        ]
                                                    }
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "alkaline phosphatase < 3.0 x ULN",
                                        "criterion": "alkaline phosphatase",
                                        "requirement": {
                                            "requirement_type": "quantity",
                                            "expected_value": {
                                                "operator": "<",
                                                "value": 3.0,
                                                "unit": "x ULN"
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "calculated creatinine clearance ≥ 60 mL/min per Cockcroft and Gault formula",
                                "criterion": "calculated creatinine clearance",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 60,
                                        "unit": "mL/min per Cockcroft and Gault formula"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "condition": {
                            "exact_snippets": "patients may receive packed red blood cells (RBC) transfusion to achieve this level at the discretion of the investigator",
                            "criterion": "RBC transfusion",
                            "requirement": {
                                "requirement_type": "discretion",
                                "expected_value": "investigator"
                            }
                        },
                        "then_criteria": null,
                        "else_criteria": null
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "11. Satisfy one of the following:",
                "criterions": [
                    {
                        "exact_snippets": "Satisfy one of the following",
                        "criterion": "satisfaction of one of the following criteria",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "one of the following criteria"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Satisfy one of the following",
                        "criterion": "satisfaction of one of the following criteria",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "one of the following criteria"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Females: non-pregnant and non-lactating; surgically sterile, post-menopausal, or patient/partner compliant with a reliable contraceptive regimen, as determined by the Investigator, for 4 weeks prior to screening. Patients of reproductive potential must test negative for pregnancy at screening and must agree to use a reliable method of birth control during the study period",
                "criterions": [
                    {
                        "exact_snippets": "Females: non-pregnant",
                        "criterion": "pregnancy status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "non-pregnant"
                        }
                    },
                    {
                        "exact_snippets": "Females: ... non-lactating",
                        "criterion": "lactation status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "non-lactating"
                        }
                    },
                    {
                        "exact_snippets": "Females: ... surgically sterile",
                        "criterion": "surgical sterility",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Females: ... post-menopausal",
                        "criterion": "menopausal status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "post-menopausal"
                        }
                    },
                    {
                        "exact_snippets": "Females: ... patient/partner compliant with a reliable contraceptive regimen",
                        "criterion": "contraceptive compliance",
                        "requirement": {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Females: ... for 4 weeks prior to screening",
                        "criterion": "contraceptive compliance duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Patients of reproductive potential must test negative for pregnancy at screening",
                        "criterion": "pregnancy test result",
                        "requirement": {
                            "requirement_type": "test result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "Patients of reproductive potential ... must agree to use a reliable method of birth control during the study period",
                        "criterion": "birth control agreement",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "and_criteria": [
                                                    {
                                                        "and_criteria": [
                                                            {
                                                                "and_criteria": [
                                                                    {
                                                                        "exact_snippets": "Females: non-pregnant",
                                                                        "criterion": "pregnancy status",
                                                                        "requirement": {
                                                                            "requirement_type": "status",
                                                                            "expected_value": "non-pregnant"
                                                                        }
                                                                    },
                                                                    {
                                                                        "exact_snippets": "Females: ... non-lactating",
                                                                        "criterion": "lactation status",
                                                                        "requirement": {
                                                                            "requirement_type": "status",
                                                                            "expected_value": "non-lactating"
                                                                        }
                                                                    }
                                                                ]
                                                            },
                                                            {
                                                                "or_criteria": [
                                                                    {
                                                                        "exact_snippets": "Females: ... surgically sterile",
                                                                        "criterion": "surgical sterility",
                                                                        "requirement": {
                                                                            "requirement_type": "status",
                                                                            "expected_value": true
                                                                        }
                                                                    },
                                                                    {
                                                                        "exact_snippets": "Females: ... post-menopausal",
                                                                        "criterion": "menopausal status",
                                                                        "requirement": {
                                                                            "requirement_type": "status",
                                                                            "expected_value": "post-menopausal"
                                                                        }
                                                                    },
                                                                    {
                                                                        "and_criteria": [
                                                                            {
                                                                                "exact_snippets": "Females: ... patient/partner compliant with a reliable contraceptive regimen",
                                                                                "criterion": "contraceptive compliance",
                                                                                "requirement": {
                                                                                    "requirement_type": "compliance",
                                                                                    "expected_value": true
                                                                                }
                                                                            },
                                                                            {
                                                                                "exact_snippets": "Females: ... for 4 weeks prior to screening",
                                                                                "criterion": "contraceptive compliance duration",
                                                                                "requirement": {
                                                                                    "requirement_type": "duration",
                                                                                    "expected_value": {
                                                                                        "operator": ">=",
                                                                                        "value": 4,
                                                                                        "unit": "weeks"
                                                                                    }
                                                                                }
                                                                            }
                                                                        ]
                                                                    }
                                                                ]
                                                            }
                                                        ]
                                                    }
                                                ]
                                            },
                                            {
                                                "exact_snippets": "Patients of reproductive potential must test negative for pregnancy at screening",
                                                "criterion": "pregnancy test result",
                                                "requirement": {
                                                    "requirement_type": "test result",
                                                    "expected_value": "negative"
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "Patients of reproductive potential ... must agree to use a reliable method of birth control during the study period",
                                        "criterion": "birth control agreement",
                                        "requirement": {
                                            "requirement_type": "agreement",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Females: ... patient/partner compliant with a reliable contraceptive regimen",
                        "criterion": "contraceptive compliance",
                        "requirement": {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Males: surgically sterile or patient/partner must agree to use a reliable contraceptive method, as determined by the Investigator, during the study period",
                "criterions": [
                    {
                        "exact_snippets": "Males: surgically sterile",
                        "criterion": "surgical sterility",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "patient/partner must agree to use a reliable contraceptive method",
                        "criterion": "contraceptive method usage",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Males: surgically sterile",
                        "criterion": "surgical sterility",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "patient/partner must agree to use a reliable contraceptive method",
                        "criterion": "contraceptive method usage",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* The patient is willing and able to comply with the study visit schedule and procedures, and has geographical proximity (Investigator's discretion) that allows follow-up specified by the protocol",
                "criterions": [
                    {
                        "exact_snippets": "The patient is willing and able to comply with the study visit schedule and procedures",
                        "criterion": "compliance with study visit schedule and procedures",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "The patient is willing and able to comply with the study visit schedule and procedures",
                        "criterion": "compliance with study visit schedule and procedures",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "has geographical proximity (Investigator's discretion) that allows follow-up specified by the protocol",
                        "criterion": "geographical proximity",
                        "requirement": {
                            "requirement_type": "suitability for follow-up",
                            "expected_value": "Investigator's discretion"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "The patient is willing and able to comply with the study visit schedule and procedures",
                                "criterion": "compliance with study visit schedule and procedures",
                                "requirement": {
                                    "requirement_type": "willingness",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "The patient is willing and able to comply with the study visit schedule and procedures",
                                "criterion": "compliance with study visit schedule and procedures",
                                "requirement": {
                                    "requirement_type": "ability",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "has geographical proximity (Investigator's discretion) that allows follow-up specified by the protocol",
                        "criterion": "geographical proximity",
                        "requirement": {
                            "requirement_type": "suitability for follow-up",
                            "expected_value": "Investigator's discretion"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* For Part 1: have discontinued all prior chemotherapies, biological therapies, and other investigational therapies for cancer for at least 4 weeks (6 weeks for mitomycin-C or nitrosoureas) prior to study treatment and have recovered from the acute effects of therapy",
                "criterions": [
                    {
                        "exact_snippets": "have discontinued all prior chemotherapies, biological therapies, and other investigational therapies for cancer for at least 4 weeks",
                        "criterion": "discontinuation of prior therapies",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "(6 weeks for mitomycin-C or nitrosoureas)",
                        "criterion": "discontinuation of mitomycin-C or nitrosoureas",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "have recovered from the acute effects of therapy",
                        "criterion": "recovery from acute effects of therapy",
                        "requirement": {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "have discontinued all prior chemotherapies, biological therapies, and other investigational therapies for cancer for at least 4 weeks",
                                        "criterion": "discontinuation of prior therapies",
                                        "requirement": {
                                            "requirement_type": "duration",
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                                                "operator": ">=",
                                                "value": 4,
                                                "unit": "weeks"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "have recovered from the acute effects of therapy",
                                        "criterion": "recovery from acute effects of therapy",
                                        "requirement": {
                                            "requirement_type": "recovery",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "(6 weeks for mitomycin-C or nitrosoureas)",
                                        "criterion": "discontinuation of mitomycin-C or nitrosoureas",
                                        "requirement": {
                                            "requirement_type": "duration",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 6,
                                                "unit": "weeks"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "have recovered from the acute effects of therapy",
                                        "criterion": "recovery from acute effects of therapy",
                                        "requirement": {
                                            "requirement_type": "recovery",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
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                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
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                            "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": "2. Treatment with another investigational drug, biological agent, or device within 4 weeks (6 weeks for biological agents) before screening or 5 half-lives of study agent, whichever is longer",
                "criterions": [
                    {
                        "exact_snippets": "Treatment with another investigational drug, biological agent, or device within 4 weeks (6 weeks for biological agents) before screening",
                        "criterion": "treatment with investigational drug, biological agent, or device",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "5 half-lives of study agent, whichever is longer",
                        "criterion": "time since last treatment with study agent",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": "5 half-lives"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Treatment with another investigational drug, biological agent, or device within 4 weeks (6 weeks for biological agents) before screening",
                                        "criterion": "treatment with investigational drug, biological agent, or device",
                                        "requirement": {
                                            "requirement_type": "time since last treatment",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": ">=",
                                                        "value": 4,
                                                        "unit": "weeks"
                                                    }
                                                ]
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "5 half-lives of study agent, whichever is longer",
                                        "criterion": "time since last treatment with study agent",
                                        "requirement": {
                                            "requirement_type": "time since last treatment",
                                            "expected_value": "5 half-lives"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Patients with treated or untreated parenchymal brain metastases or leptomeningeal disease. Brain imaging is required for symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients",
                "criterions": [
                    {
                        "exact_snippets": "treated or untreated parenchymal brain metastases",
                        "criterion": "parenchymal brain metastases",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": [
                                "treated",
                                "untreated"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "leptomeningeal disease",
                        "criterion": "leptomeningeal disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Brain imaging is required for symptomatic patients",
                        "criterion": "brain imaging",
                        "requirement": {
                            "requirement_type": "requirement",
                            "expected_value": "required for symptomatic patients"
                        }
                    },
                    {
                        "exact_snippets": "Brain imaging ... is not required in asymptomatic patients",
                        "criterion": "brain imaging",
                        "requirement": {
                            "requirement_type": "requirement",
                            "expected_value": "not required for asymptomatic patients"
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "treated or untreated parenchymal brain metastases",
                                        "criterion": "parenchymal brain metastases",
                                        "requirement": {
                                            "requirement_type": "treatment status",
                                            "expected_value": [
                                                "treated",
                                                "untreated"
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                                        }
                                    },
                                    {
                                        "exact_snippets": "Brain imaging is required for symptomatic patients",
                                        "criterion": "brain imaging",
                                        "requirement": {
                                            "requirement_type": "requirement",
                                            "expected_value": "required for symptomatic patients"
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "treated or untreated parenchymal brain metastases",
                                        "criterion": "parenchymal brain metastases",
                                        "requirement": {
                                            "requirement_type": "treatment status",
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                                                "untreated"
                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "Brain imaging ... is not required in asymptomatic patients",
                                        "criterion": "brain imaging",
                                        "requirement": {
                                            "requirement_type": "requirement",
                                            "expected_value": "not required for asymptomatic patients"
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "leptomeningeal disease",
                        "criterion": "leptomeningeal disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Patients with known pericardial effusion",
                "criterions": [
                    {
                        "exact_snippets": "known pericardial effusion",
                        "criterion": "pericardial effusion",
                        "requirement": {
                            "requirement_type": "presence",
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                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "known pericardial effusion",
                        "criterion": "pericardial effusion",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Patients with active infection or serious concomitant systemic disorder (for example, heart failure) incompatible with the study (at the discretion of the Investigator)",
                "criterions": [
                    {
                        "exact_snippets": "Patients with active infection",
                        "criterion": "active infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "serious concomitant systemic disorder",
                        "criterion": "serious concomitant systemic disorder",
                        "requirement": {
                            "requirement_type": "compatibility with the study",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Patients with active infection",
                        "criterion": "active infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "serious concomitant systemic disorder",
                        "criterion": "serious concomitant systemic disorder",
                        "requirement": {
                            "requirement_type": "compatibility with the study",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Presence or history of malignancy other than NSCLC, carcinoma in situ of the cervix, or non-melanoma skin cancer. In the case of other malignancies, patients may be considered for participation if the prior malignancies were diagnosed and definitively treated at least two years previously with no subsequent evidence of recurrence.",
                "criterions": [
                    {
                        "exact_snippets": "Presence or history of malignancy other than NSCLC, carcinoma in situ of the cervix, or non-melanoma skin cancer.",
                        "criterion": "malignancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Presence or history of malignancy other than NSCLC, carcinoma in situ of the cervix, or non-melanoma skin cancer.",
                        "criterion": "malignancy",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "In the case of other malignancies, patients may be considered for participation if the prior malignancies were diagnosed and definitively treated at least two years previously with no subsequent evidence of recurrence.",
                        "criterion": "prior malignancies",
                        "requirement": {
                            "requirement_type": "diagnosis and treatment time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "In the case of other malignancies, patients may be considered for participation if the prior malignancies were diagnosed and definitively treated at least two years previously with no subsequent evidence of recurrence.",
                        "criterion": "prior malignancies",
                        "requirement": {
                            "requirement_type": "recurrence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
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                        "or_criteria": [
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                                "and_criteria": [
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                                        "and_criteria": [
                                            {
                                                "exact_snippets": "Presence or history of malignancy other than NSCLC, carcinoma in situ of the cervix, or non-melanoma skin cancer.",
                                                "criterion": "malignancy",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": false
                                                }
                                            },
                                            {
                                                "exact_snippets": "Presence or history of malignancy other than NSCLC, carcinoma in situ of the cervix, or non-melanoma skin cancer.",
                                                "criterion": "malignancy",
                                                "requirement": {
                                                    "requirement_type": "history",
                                                    "expected_value": false
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "or_criteria": [
                                            {
                                                "exact_snippets": "In the case of other malignancies, patients may be considered for participation if the prior malignancies were diagnosed and definitively treated at least two years previously with no subsequent evidence of recurrence.",
                                                "criterion": "prior malignancies",
                                                "requirement": {
                                                    "requirement_type": "diagnosis and treatment time",
                                                    "expected_value": {
                                                        "operator": ">=",
                                                        "value": 2,
                                                        "unit": "years"
                                                    }
                                                }
                                            },
                                            {
                                                "exact_snippets": "In the case of other malignancies, patients may be considered for participation if the prior malignancies were diagnosed and definitively treated at least two years previously with no subsequent evidence of recurrence.",
                                                "criterion": "prior malignancies",
                                                "requirement": {
                                                    "requirement_type": "recurrence",
                                                    "expected_value": false
                                                }
                                            }
                                        ]
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "In the case of other malignancies, patients may be considered for participation if the prior malignancies were diagnosed and definitively treated at least two years previously with no subsequent evidence of recurrence.",
                                "criterion": "prior malignancies",
                                "requirement": {
                                    "requirement_type": "diagnosis and treatment time",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "years"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "In the case of other malignancies, patients may be considered for participation if the prior malignancies were diagnosed and definitively treated at least two years previously with no subsequent evidence of recurrence.",
                                "criterion": "prior malignancies",
                                "requirement": {
                                    "requirement_type": "recurrence",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Presence of an underlying disease state associated with active bleeding",
                "criterions": [
                    {
                        "exact_snippets": "Presence of an underlying disease state associated with active bleeding",
                        "criterion": "underlying disease state",
                        "requirement": {
                            "requirement_type": "association",
                            "expected_value": "active bleeding"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Presence of an underlying disease state associated with active bleeding",
                    "criterion": "underlying disease state",
                    "requirement": {
                        "requirement_type": "association",
                        "expected_value": "active bleeding"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "8. Concurrent treatment with other anticancer drugs",
                "criterions": [
                    {
                        "exact_snippets": "Concurrent treatment with other anticancer drugs",
                        "criterion": "concurrent treatment with anticancer drugs",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Concurrent treatment with other anticancer drugs",
                    "criterion": "concurrent treatment with anticancer drugs",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "9. Pre-existing peripheral neuropathy ≥ Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE) Grade 2",
                "criterions": [
                    {
                        "exact_snippets": "Pre-existing peripheral neuropathy ≥ Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE) Grade 2",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "CTCAE Grade"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Pre-existing peripheral neuropathy ≥ Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE) Grade 2",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "CTCAE Grade"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "10. Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device",
                "criterions": [
                    {
                        "exact_snippets": "Planned concomitant participation in another clinical trial",
                        "criterion": "concomitant clinical trial participation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "experimental agent",
                        "criterion": "experimental agent",
                        "requirement": {
                            "requirement_type": "participation",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "experimental ... vaccine",
                        "criterion": "experimental vaccine",
                        "requirement": {
                            "requirement_type": "participation",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "experimental ... device",
                        "criterion": "experimental device",
                        "requirement": {
                            "requirement_type": "participation",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Planned concomitant participation in another clinical trial",
                                "criterion": "concomitant clinical trial participation",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "experimental agent",
                                        "criterion": "experimental agent",
                                        "requirement": {
                                            "requirement_type": "participation",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "experimental ... vaccine",
                                        "criterion": "experimental vaccine",
                                        "requirement": {
                                            "requirement_type": "participation",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "experimental ... device",
                                        "criterion": "experimental device",
                                        "requirement": {
                                            "requirement_type": "participation",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "11. Patients with any other medical conditions that in the opinion of the Investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in or completing the study",
                "criterions": [
                    {
                        "exact_snippets": "any other medical conditions ... would make the patient unsuitable for enrollment",
                        "criterion": "medical conditions",
                        "requirement": {
                            "requirement_type": "suitability",
                            "expected_value": "suitable for enrollment"
                        }
                    },
                    {
                        "exact_snippets": "any other medical conditions ... could interfere with the patient participating in or completing the study",
                        "criterion": "medical conditions",
                        "requirement": {
                            "requirement_type": "interference",
                            "expected_value": "no interference with participation or completion"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "any other medical conditions ... would make the patient unsuitable for enrollment",
                        "criterion": "medical conditions",
                        "requirement": {
                            "requirement_type": "suitability",
                            "expected_value": "suitable for enrollment"
                        }
                    },
                    {
                        "exact_snippets": "any other medical conditions ... could interfere with the patient participating in or completing the study",
                        "criterion": "medical conditions",
                        "requirement": {
                            "requirement_type": "interference",
                            "expected_value": "no interference with participation or completion"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "12. Allergy to berries",
                "criterions": [
                    {
                        "exact_snippets": "Allergy to berries",
                        "criterion": "allergy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Allergy to berries",
                        "criterion": "allergy",
                        "requirement": {
                            "requirement_type": "substance",
                            "expected_value": "berries"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Allergy to berries",
                        "criterion": "allergy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Allergy to berries",
                        "criterion": "allergy",
                        "requirement": {
                            "requirement_type": "substance",
                            "expected_value": "berries"
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "7. Part 2: Have measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) as > 10 millimeters (mm) on cross-sectional imaging (where the CT slice thickness is no greater than 5 mm) or at least 20 mm by standard techniques; positron emissions tomography [PET] and ultrasound are not permitted methods for tumor measurements under this protocol.",
                "criterions": [
                    {
                        "exact_snippets": "measurable disease",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "at least 1 lesion that can be accurately measured",
                        "criterion": "lesion",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    },
                    {
                        "exact_snippets": "at least 1 dimension (longest diameter to be recorded) as > 10 millimeters (mm) on cross-sectional imaging",
                        "criterion": "lesion size",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "CT slice thickness is no greater than 5 mm",
                        "criterion": "CT slice thickness",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "mm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "at least 20 mm by standard techniques",
                        "criterion": "lesion size by standard techniques",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "mm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "positron emissions tomography [PET] and ultrasound are not permitted methods for tumor measurements",
                        "criterion": "tumor measurement methods",
                        "requirement": {
                            "requirement_type": "permitted methods",
                            "expected_value": [
                                "cross-sectional imaging",
                                "standard techniques"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "and_criteria": [
                                                    {
                                                        "and_criteria": [
                                                            {
                                                                "exact_snippets": "measurable disease",
                                                                "criterion": "measurable disease",
                                                                "requirement": {
                                                                    "requirement_type": "presence",
                                                                    "expected_value": true
                                                                }
                                                            },
                                                            {
                                                                "exact_snippets": "at least 1 lesion that can be accurately measured",
                                                                "criterion": "lesion",
                                                                "requirement": {
                                                                    "requirement_type": "quantity",
                                                                    "expected_value": {
                                                                        "operator": ">=",
                                                                        "value": 1,
                                                                        "unit": "lesion"
                                                                    }
                                                                }
                                                            }
                                                        ]
                                                    }
                                                ]
                                            }
                                        ]
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "1. Part 1: More than one prior chemotherapy (single biological therapy, i.e., Erlotinib not included) regimens (approved or experimental) for NSCLC, not counting adjuvant and neoadjuvant treatment. A regimen is defined as two or more consecutive cycles of treatment. Part 2: Any prior chemotherapy or biological therapy (approved or experimental) for NSCLC including adjuvant and neoadjuvant treatments",
                "criterions": [
                    {
                        "exact_snippets": "More than one prior chemotherapy ... regimens ... for NSCLC",
                        "criterion": "prior chemotherapy regimens for NSCLC",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "regimens"
                            }
                        }
                    },
                    {
                        "exact_snippets": "single biological therapy, i.e., Erlotinib not included",
                        "criterion": "prior biological therapy",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "Erlotinib"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "not counting adjuvant and neoadjuvant treatment",
                        "criterion": "prior chemotherapy regimens for NSCLC",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "adjuvant treatment",
                                "neoadjuvant treatment"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "A regimen is defined as two or more consecutive cycles of treatment",
                        "criterion": "regimen definition",
                        "requirement": {
                            "requirement_type": "definition",
                            "expected_value": "two or more consecutive cycles of treatment"
                        }
                    },
                    {
                        "exact_snippets": "Any prior chemotherapy or biological therapy ... for NSCLC",
                        "criterion": "prior chemotherapy or biological therapy for NSCLC",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "including adjuvant and neoadjuvant treatments",
                        "criterion": "prior chemotherapy or biological therapy for NSCLC",
                        "requirement": {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "adjuvant treatment",
                                "neoadjuvant treatment"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_miscellaneous": []
}