{
    "info": {
        "nct_id": "NCT00094861",
        "official_title": "A Phase 2 Study to Evaluate the Efficacy and Safety of Palifermin (Recombinant Human Keratinocyte Growth Factor) in the Reduction of Dysphagia in Patients Receiving Concurrent Chemoradiotherapy Followed by Consolidation Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)",
        "inclusion_criteria": "* Patients with a histologically or cytologically proven diagnosis of NSCLC\n* Unresectable (locally advanced) stage IIIa or IIIb disease\n* Initial radiotherapy field of treatment to encompass greater than or equal to 30% of the esophagus\n* Life expectancy greater than or equal to 6 months\n* Estimated weight loss less than or equal to 10% in the 3 months before study randomization\n* Measurable disease\n* 18 years of age or older\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2\n* Hemoglobin (hgb) greater than or equal to 10 g/dL without transfusional support or growth factor use in the 4 weeks before study randomization\n* Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L without growth factor use in the 2 weeks before study randomization\n* Platelet count greater than or equal to 100 x 10^9/L\n* Serum bilirubin less than or equal to 1.5 x institutional upper limit of normal (ULN)\n* Serum creatinine less than or equal to 2.0 mg/dL (Note: Patients with a serum creatinine greater than or equal to 1.4 and less than or equal to 2.0 mg/dL must demonstrate a 24-hour urinary creatinine clearance greater than or equal to 50 mL/min)\n* Females of childbearing potential: negative serum or urine pregnancy test\n* Patient must give written informed consent before participating in any study-specific procedure, randomization, or receiving investigational product.\n* Patients with reproductive capability must agree to practice adequate contraception methods.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Metastatic disease (M1)/stage 4 NSCLC\n* Pleural or pericardial effusion greater than 100 ml in volume as documented by appropriate imaging (positron emission tomography [PET], computed tomography [CT] scan or ultrasound). If an effusion greater than 100 ml is documented by cytology to be free from malignancy and the investigator feels the patient is capable of receiving chemo/radiotherapy for their primary disease/ NSCLC, the investigator should discuss the patient with the study physician at Amgen. Effusions smaller than 100 ml would be acceptable, unless the investigator suspects that the effusion is malignant, in which case the effusions should be evaluated by cytology. Sponsor approval must be obtained before patient is randomized.\n* Plan to remove the tumor surgically before completing the protocol chemo/radiotherapy course\n* Shielding of any part of the esophagus during radiotherapy (including posterior spinal cord shielding)\n* Prior chemotherapy, radiotherapy, or surgery for NSCLC\n* Prior invasive malignancy during the past 3 years other than non-melanomatous skin cancer. Note: Patients with prior surgically-cured malignancies [eg, stage I breast cancer or prostate cancer, in-situ carcinoma of the cervix, etc] are not excluded; however, sponsor approval must be obtained before patient is randomized.\n* Presence or history of dysphagia or conditions predisposing to dysphagia (eg, uncontrolled gastroesophageal reflux disease [GERD], dyspepsia, etc)\n* History of pancreatitis\n* Four weeks or less since completion of treatment using an investigational product/device in another clinical study or presence of any unresolved toxicity from previous treatment\n* Previous treatment on this study or with a fibroblast growth factor\n* Known to be sero-positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV)\n* Pregnant or breastfeeding women\n* Known sensitivity to E. coli derived products\n* Compromised ability of the patient to give written informed consent and/or to comply with study procedures\n* Refusal to sign an informed consent form to participate in this study, and sign the hospital information release form, if applicable\n* Unwilling or unable to complete the patient reported outcome (PRO) questionnaires\n* Psychological, social, familial, or geographical reasons that would prevent regular follow-up",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients with a histologically or cytologically proven diagnosis of NSCLC",
            "criterions": [
                {
                    "exact_snippets": [
                        "histologically or cytologically proven diagnosis of NSCLC"
                    ],
                    "criterion": "NSCLC diagnosis",
                    "requirement_type": "method of confirmation",
                    "expected_value": [
                        "histologically",
                        "cytologically"
                    ]
                }
            ]
        },
        {
            "line": "* Unresectable (locally advanced) stage IIIa or IIIb disease",
            "criterions": [
                {
                    "exact_snippets": [
                        "Unresectable"
                    ],
                    "criterion": "disease",
                    "requirement_type": "resectability",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "locally advanced"
                    ],
                    "criterion": "disease",
                    "requirement_type": "stage",
                    "expected_value": "locally advanced"
                },
                {
                    "exact_snippets": [
                        "stage IIIa or IIIb"
                    ],
                    "criterion": "disease",
                    "requirement_type": "stage",
                    "expected_value": [
                        "IIIa",
                        "IIIb"
                    ]
                }
            ]
        },
        {
            "line": "* Initial radiotherapy field of treatment to encompass greater than or equal to 30% of the esophagus",
            "criterions": [
                {
                    "exact_snippets": [
                        "Initial radiotherapy field of treatment"
                    ],
                    "criterion": "radiotherapy field of treatment",
                    "requirement_type": "initial",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "encompass greater than or equal to 30% of the esophagus"
                    ],
                    "criterion": "esophagus",
                    "requirement_type": "coverage",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 30
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Life expectancy greater than or equal to 6 months",
            "criterions": [
                {
                    "exact_snippets": [
                        "Life expectancy greater than or equal to 6 months"
                    ],
                    "criterion": "life expectancy",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 6
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Estimated weight loss less than or equal to 10% in the 3 months before study randomization",
            "criterions": [
                {
                    "exact_snippets": [
                        "Estimated weight loss",
                        "less than or equal to 10%"
                    ],
                    "criterion": "weight loss",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 10
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "in the 3 months before study randomization"
                    ],
                    "criterion": "time frame before study randomization",
                    "requirement_type": "duration",
                    "expected_value": "3 months"
                }
            ]
        },
        {
            "line": "* Measurable disease",
            "criterions": [
                {
                    "exact_snippets": [
                        "Measurable disease"
                    ],
                    "criterion": "disease",
                    "requirement_type": "measurability",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* 18 years of age or older",
            "criterions": [
                {
                    "exact_snippets": [
                        "18 years of age or older"
                    ],
                    "criterion": "age",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 18
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2",
            "criterions": [
                {
                    "exact_snippets": [
                        "Eastern Cooperative Oncology Group (ECOG) performance status"
                    ],
                    "criterion": "ECOG performance status",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 0
                            },
                            {
                                "operator": "<=",
                                "value": 2
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Hemoglobin (hgb) greater than or equal to 10 g/dL without transfusional support or growth factor use in the 4 weeks before study randomization",
            "criterions": [
                {
                    "exact_snippets": [
                        "Hemoglobin (hgb) greater than or equal to 10 g/dL"
                    ],
                    "criterion": "hemoglobin",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 10
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "without transfusional support"
                    ],
                    "criterion": "transfusional support",
                    "requirement_type": "use",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "without",
                        "growth factor use"
                    ],
                    "criterion": "growth factor",
                    "requirement_type": "use",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "in the 4 weeks before study randomization"
                    ],
                    "criterion": "time before study randomization",
                    "requirement_type": "duration",
                    "expected_value": "4 weeks"
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L without growth factor use in the 2 weeks before study randomization",
            "criterions": [
                {
                    "exact_snippets": [
                        "Absolute neutrophil count (ANC)",
                        "greater than or equal to 1.5 x 10^9/L"
                    ],
                    "criterion": "absolute neutrophil count",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 1500000000.0
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "without growth factor use",
                        "in the 2 weeks before study randomization"
                    ],
                    "criterion": "growth factor use",
                    "requirement_type": "absence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Platelet count greater than or equal to 100 x 10^9/L",
            "criterions": [
                {
                    "exact_snippets": [
                        "Platelet count greater than or equal to 100 x 10^9/L"
                    ],
                    "criterion": "platelet count",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 100
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Serum bilirubin less than or equal to 1.5 x institutional upper limit of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": [
                        "Serum bilirubin",
                        "less than or equal to 1.5 x institutional upper limit of normal (ULN)"
                    ],
                    "criterion": "serum bilirubin",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 1.5
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Serum creatinine less than or equal to 2.0 mg/dL (Note: Patients with a serum creatinine greater than or equal to 1.4 and less than or equal to 2.0 mg/dL must demonstrate a 24-hour urinary creatinine clearance greater than or equal to 50 mL/min)",
            "criterions": [
                {
                    "exact_snippets": [
                        "Serum creatinine less than or equal to 2.0 mg/dL"
                    ],
                    "criterion": "serum creatinine",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 2.0
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "serum creatinine greater than or equal to 1.4",
                        "less than or equal to 2.0 mg/dL"
                    ],
                    "criterion": "serum creatinine",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 1.4
                            },
                            {
                                "operator": "<=",
                                "value": 2.0
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "24-hour urinary creatinine clearance greater than or equal to 50 mL/min"
                    ],
                    "criterion": "24-hour urinary creatinine clearance",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "operator": ">=",
                        "value": 50
                    }
                }
            ]
        },
        {
            "line": "* Females of childbearing potential: negative serum or urine pregnancy test",
            "criterions": [
                {
                    "exact_snippets": [
                        "Females of childbearing potential"
                    ],
                    "criterion": "childbearing potential",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "negative serum or urine pregnancy test"
                    ],
                    "criterion": "pregnancy test",
                    "requirement_type": "result",
                    "expected_value": "negative"
                }
            ]
        },
        {
            "line": "* Patient must give written informed consent before participating in any study-specific procedure, randomization, or receiving investigational product.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patient must give written informed consent"
                    ],
                    "criterion": "informed consent",
                    "requirement_type": "provision",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Patients with reproductive capability must agree to practice adequate contraception methods.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patients with reproductive capability"
                    ],
                    "criterion": "reproductive capability",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "must agree to practice adequate contraception methods"
                    ],
                    "criterion": "contraception methods",
                    "requirement_type": "agreement to practice",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "volunteer health status",
                    "requirement_type": "allowance",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Metastatic disease (M1)/stage 4 NSCLC",
            "criterions": [
                {
                    "exact_snippets": [
                        "Metastatic disease"
                    ],
                    "criterion": "metastatic disease",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "stage 4 NSCLC"
                    ],
                    "criterion": "NSCLC",
                    "requirement_type": "stage",
                    "expected_value": "4"
                }
            ]
        },
        {
            "line": "* Pleural or pericardial effusion greater than 100 ml in volume as documented by appropriate imaging (positron emission tomography [PET], computed tomography [CT] scan or ultrasound). If an effusion greater than 100 ml is documented by cytology to be free from malignancy and the investigator feels the patient is capable of receiving chemo/radiotherapy for their primary disease/ NSCLC, the investigator should discuss the patient with the study physician at Amgen. Effusions smaller than 100 ml would be acceptable, unless the investigator suspects that the effusion is malignant, in which case the effusions should be evaluated by cytology. Sponsor approval must be obtained before patient is randomized.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Pleural or pericardial effusion greater than 100 ml in volume"
                    ],
                    "criterion": "pleural or pericardial effusion",
                    "requirement_type": "volume",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 100
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "effusion greater than 100 ml is documented by cytology to be free from malignancy"
                    ],
                    "criterion": "effusion",
                    "requirement_type": "malignancy",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "Effusions smaller than 100 ml would be acceptable"
                    ],
                    "criterion": "effusion",
                    "requirement_type": "volume",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 100
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "unless the investigator suspects that the effusion is malignant"
                    ],
                    "criterion": "effusion",
                    "requirement_type": "malignancy",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Plan to remove the tumor surgically before completing the protocol chemo/radiotherapy course",
            "criterions": [
                {
                    "exact_snippets": [
                        "remove the tumor surgically"
                    ],
                    "criterion": "tumor",
                    "requirement_type": "removal plan",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "before completing the protocol chemo/radiotherapy course"
                    ],
                    "criterion": "protocol chemo/radiotherapy course",
                    "requirement_type": "completion",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* Shielding of any part of the esophagus during radiotherapy (including posterior spinal cord shielding)",
            "criterions": [
                {
                    "exact_snippets": [
                        "Shielding of any part of the esophagus during radiotherapy"
                    ],
                    "criterion": "esophagus",
                    "requirement_type": "shielding during radiotherapy",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "posterior spinal cord shielding"
                    ],
                    "criterion": "spinal cord",
                    "requirement_type": "posterior shielding",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Prior invasive malignancy during the past 3 years other than non-melanomatous skin cancer. Note: Patients with prior surgically-cured malignancies [eg, stage I breast cancer or prostate cancer, in-situ carcinoma of the cervix, etc] are not excluded; however, sponsor approval must be obtained before patient is randomized.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Prior invasive malignancy during the past 3 years"
                    ],
                    "criterion": "prior invasive malignancy",
                    "requirement_type": "time frame",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 3
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "non-melanomatous skin cancer"
                    ],
                    "criterion": "non-melanomatous skin cancer",
                    "requirement_type": "exclusion",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "prior surgically-cured malignancies"
                    ],
                    "criterion": "prior surgically-cured malignancies",
                    "requirement_type": "exclusion",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "sponsor approval must be obtained"
                    ],
                    "criterion": "sponsor approval",
                    "requirement_type": "requirement",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Presence or history of dysphagia or conditions predisposing to dysphagia (eg, uncontrolled gastroesophageal reflux disease [GERD], dyspepsia, etc)",
            "criterions": [
                {
                    "exact_snippets": [
                        "Presence or history of dysphagia"
                    ],
                    "criterion": "dysphagia",
                    "requirement_type": "presence or history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "conditions predisposing to dysphagia"
                    ],
                    "criterion": "conditions predisposing to dysphagia",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "uncontrolled gastroesophageal reflux disease [GERD]"
                    ],
                    "criterion": "gastroesophageal reflux disease",
                    "requirement_type": "control",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "dyspepsia"
                    ],
                    "criterion": "dyspepsia",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* History of pancreatitis",
            "criterions": [
                {
                    "exact_snippets": [
                        "History of pancreatitis"
                    ],
                    "criterion": "pancreatitis",
                    "requirement_type": "history",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Four weeks or less since completion of treatment using an investigational product/device in another clinical study or presence of any unresolved toxicity from previous treatment",
            "criterions": [
                {
                    "exact_snippets": [
                        "Four weeks or less since completion of treatment using an investigational product/device in another clinical study"
                    ],
                    "criterion": "time since completion of treatment in another clinical study",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 4
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "presence of any unresolved toxicity from previous treatment"
                    ],
                    "criterion": "unresolved toxicity from previous treatment",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Pregnant or breastfeeding women",
            "criterions": [
                {
                    "exact_snippets": [
                        "Pregnant"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "status",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "breastfeeding"
                    ],
                    "criterion": "breastfeeding",
                    "requirement_type": "status",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Known sensitivity to E. coli derived products",
            "criterions": [
                {
                    "exact_snippets": [
                        "Known sensitivity to E. coli derived products"
                    ],
                    "criterion": "sensitivity to E. coli derived products",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Compromised ability of the patient to give written informed consent and/or to comply with study procedures",
            "criterions": [
                {
                    "exact_snippets": [
                        "Compromised ability of the patient to give written informed consent"
                    ],
                    "criterion": "ability to give written informed consent",
                    "requirement_type": "compromised",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "comply with study procedures"
                    ],
                    "criterion": "ability to comply with study procedures",
                    "requirement_type": "compromised",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Refusal to sign an informed consent form to participate in this study, and sign the hospital information release form, if applicable",
            "criterions": [
                {
                    "exact_snippets": [
                        "Refusal to sign an informed consent form"
                    ],
                    "criterion": "informed consent form",
                    "requirement_type": "signature",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "sign the hospital information release form"
                    ],
                    "criterion": "hospital information release form",
                    "requirement_type": "signature",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Unwilling or unable to complete the patient reported outcome (PRO) questionnaires",
            "criterions": [
                {
                    "exact_snippets": [
                        "Unwilling",
                        "to complete the patient reported outcome (PRO) questionnaires"
                    ],
                    "criterion": "completion of PRO questionnaires",
                    "requirement_type": "willingness",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "unable",
                        "to complete the patient reported outcome (PRO) questionnaires"
                    ],
                    "criterion": "completion of PRO questionnaires",
                    "requirement_type": "ability",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Psychological, social, familial, or geographical reasons that would prevent regular follow-up",
            "criterions": [
                {
                    "exact_snippets": [
                        "Psychological",
                        "reasons that would prevent regular follow-up"
                    ],
                    "criterion": "psychological reasons",
                    "requirement_type": "impact on follow-up",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "social",
                        "reasons that would prevent regular follow-up"
                    ],
                    "criterion": "social reasons",
                    "requirement_type": "impact on follow-up",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "familial",
                        "reasons that would prevent regular follow-up"
                    ],
                    "criterion": "familial reasons",
                    "requirement_type": "impact on follow-up",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "geographical",
                        "reasons that would prevent regular follow-up"
                    ],
                    "criterion": "geographical reasons",
                    "requirement_type": "impact on follow-up",
                    "expected_value": true
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Prior chemotherapy, radiotherapy, or surgery for NSCLC",
            "criterions": [
                {
                    "exact_snippets": [
                        "Prior chemotherapy"
                    ],
                    "criterion": "chemotherapy",
                    "requirement_type": "prior treatment",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Prior radiotherapy"
                    ],
                    "criterion": "radiotherapy",
                    "requirement_type": "prior treatment",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Prior surgery for NSCLC"
                    ],
                    "criterion": "surgery for NSCLC",
                    "requirement_type": "prior treatment",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Previous treatment on this study or with a fibroblast growth factor",
            "criterions": [
                {
                    "exact_snippets": [
                        "Previous treatment on this study"
                    ],
                    "criterion": "previous treatment",
                    "requirement_type": "participation",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "previous treatment",
                        "with a fibroblast growth factor"
                    ],
                    "criterion": "fibroblast growth factor treatment",
                    "requirement_type": "history",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Known to be sero-positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV)",
            "criterions": [
                {
                    "exact_snippets": [
                        "sero-positive for human immunodeficiency virus (HIV)"
                    ],
                    "criterion": "human immunodeficiency virus (HIV)",
                    "requirement_type": "sero-positivity",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "sero-positive for hepatitis C virus (HCV)"
                    ],
                    "criterion": "hepatitis C virus (HCV)",
                    "requirement_type": "sero-positivity",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "sero-positive for hepatitis B virus (HBV)"
                    ],
                    "criterion": "hepatitis B virus (HBV)",
                    "requirement_type": "sero-positivity",
                    "expected_value": true
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}