{
    "info": {
        "nct_id": "NCT03603262",
        "official_title": "A Phase I, Open-label Study to Assess the Safety, Tolerability and Pharmacokinetics of Ascending Doses of SH-1028 Tablets in Patients With Advanced Non-small Cell Lung Cancer",
        "inclusion_criteria": "1. Age from 18 to 75, both sexes.\n2. Histologically or cytologically documented NSCLC.\n3. Not amenable to radical therapy or stage IV.\n4. Radiological documentation of disease progression while on a previous continuous treatment with an EGFR TKI, e.g., gefitinib or erlotinib. In addition, other lines of therapy may have been given(chemotherapy only accept first line).\n5. Confirmation that the tumor harbors an EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q) or must have experienced clinical benefit from EGFR TKI, according to the Jackman criteria while on continuous treatment with an EGFR TKI(PR/CR、or SD continued ≥6 months).\n6. Patients must have confirmation of tumor T790M+ mutation status.\n7. Patients also must have confirmation of tumor T790M+ mutation status.\n8. World Health Organization (WHO) performance status equal to 0-1 with no deterioration over the previous 2 weeks.\n9. A minimum life expectancy of 12 weeks.\n10. At least 1 lesion that has not previously been irradiated, that can be accurately measured at Baseline as ≥ 10mm in the longest diameter (except lymph nodes which must have short axis ≥ 15mm) with computerized tomography (CT) or magnetic resonance imaging (MRI), which is suitable for accurately repeated measurements.\n11. Females of child-bearing potential should be using adequate contraceptive measures throughout the study, should not be breast feeding during the study and until 6 months after completion of study, and must have a negative pregnancy test prior to start of dosing.\n12. Male patients should be willing to use barrier contraception during the study and until 6 months after completion of study (i.e., condoms).\n13. Do not anticipate other clinical trail in 3 months.\n14. The patient must provide a written informed consent for genetic research.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Not Confirmed by pathology.\n2. An EGFR TKI within 8 days or approximately 5 times the half-life of the specific drug, whichever is longer, of the first dose of study treatment.\n3. Any cytotoxic chemotherapy used for a previous treatment regimen or clinical study within 21 days of the first dose of study treatment; Any target medicines used for a previous treatment regimen or clinical study within 14 days of the first dose of study treatment; withdrawal other clinical drugs or anti-cancer drugs less than 5 times the half-life.\n4. Ever used the third EGFR-TKI, such as AZD9291,CO-1686 or avitinib.\n5. Major surgery within 4 weeks of the first dose of study treatment.\n6. Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment, with the exception of patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation which must be completed within 4 weeks of the first dose of study treatment.\n7. The patient is currently using (or cannot discontinue at least 1 week before the first dose of study treatment) a drug or herbal supplement known as a potent inhibitor or inducer of CYP3A4.\n8. Use large doses of glucocorticoids or other immunosuppressive agents within 4 weeks.\n9. Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE), Grade 1, at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy.\n10. Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study treatment.\n11. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension or active bleeding diatheses, which, in the Investigator's opinion, makes it undesirable for the patient to participate in the trial.\n12. Active infection (e.g., hepatitis B, hepatitis C or human immunodeficiency virus [HIV]). (HBsAg is positive but HBV-DNA <1×103 IU/ mL ,and HCVAb is positive but HCV-RNA<103 IU/mL can be accepted.）.\n13. Any of the following cardiac criteria:\n\n    1. Mean resting corrected QT interval (QTc) > 470 msec obtained from 3 electrocardiograms (ECGs), using the Screening clinic ECG machine and Fridericia's formula for QT interval correction.\n    2. Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG (e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval >250msec).\n    3. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval.\n14. Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.\n15. Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:\n\n    1. Absolute neutrophil count < 1.5 x 109/L.\n    2. Platelet count < 100 x 109/L.\n    3. Hemoglobin < 90 g/L (< 9 g/dL).\n    4. Alanine aminotransferase > 2.5 times the upper limit of normal (ULN) if no demonstrable liver metastases or > 5 times the ULN in the presence of liver metastases.\n    5. Aspartate aminotransferase > 2.5 times the ULN if no demonstrable liver metastases or > 5 times the ULN in the presence of liver metastases.\n    6. Total bilirubin > 1.5 times the ULN if no liver metastases or > 3 times the ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases.\n    7. Creatinine > 1.5 times the ULN concurrent with creatinine clearance < 50 mL/min (measured or calculated by the Cockcroft - Gault equation); confirmation of creatinine clearance is only required when creatinine is > 1.5 times the ULN.\n16. Have any other malignant tumor within five years (except clinically cured cervical carcinoma in situ, basal cells or squamous epithelial skin cancer).\n17. Refractory nausea, vomiting, or chronic gastrointestinal diseases, inability to swallow the study medication, or previous significant bowel resection that would preclude adequate absorption of SH-1028.\n18. History of hypersensitivity to any active or inactive ingredient of SH-1028 or to a drug with a similar chemical structure or class to SH-1028.\n19. Women who are breast feeding.\n20. Any disease or condition that, in the opinion of the Investigator, would compromise the safety of the patient or interfere with study assessments.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. Age from 18 to 75, both sexes.",
                "criterions": [
                    {
                        "exact_snippets": "Age from 18 to 75",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "both sexes",
                        "criterion": "sex",
                        "requirement": {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age from 18 to 75",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "both sexes",
                        "criterion": "sex",
                        "requirement": {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Histologically or cytologically documented NSCLC.",
                "criterions": [
                    {
                        "exact_snippets": "Histologically or cytologically documented NSCLC",
                        "criterion": "NSCLC",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Histologically or cytologically documented NSCLC",
                        "criterion": "NSCLC",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Not amenable to radical therapy or stage IV.",
                "criterions": [
                    {
                        "exact_snippets": "Not amenable to radical therapy",
                        "criterion": "amenability to radical therapy",
                        "requirement": {
                            "requirement_type": "amenability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "stage IV",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "Not amenable to radical therapy",
                            "criterion": "amenability to radical therapy",
                            "requirement": {
                                "requirement_type": "amenability",
                                "expected_value": false
                            }
                        }
                    },
                    {
                        "exact_snippets": "stage IV",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Radiological documentation of disease progression while on a previous continuous treatment with an EGFR TKI, e.g., gefitinib or erlotinib. In addition, other lines of therapy may have been given(chemotherapy only accept first line).",
                "criterions": [
                    {
                        "exact_snippets": "Radiological documentation of disease progression",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": "radiological"
                        }
                    },
                    {
                        "exact_snippets": "previous continuous treatment with an EGFR TKI, e.g., gefitinib or erlotinib",
                        "criterion": "previous treatment",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "EGFR TKI"
                        }
                    },
                    {
                        "exact_snippets": "previous continuous treatment with an EGFR TKI, e.g., gefitinib or erlotinib",
                        "criterion": "previous treatment",
                        "requirement": {
                            "requirement_type": "continuity",
                            "expected_value": "continuous"
                        }
                    },
                    {
                        "exact_snippets": "other lines of therapy may have been given(chemotherapy only accept first line)",
                        "criterion": "lines of therapy",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "chemotherapy"
                        }
                    },
                    {
                        "exact_snippets": "other lines of therapy may have been given(chemotherapy only accept first line)",
                        "criterion": "lines of therapy",
                        "requirement": {
                            "requirement_type": "line",
                            "expected_value": "first"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Radiological documentation of disease progression",
                                        "criterion": "disease progression",
                                        "requirement": {
                                            "requirement_type": "documentation",
                                            "expected_value": "radiological"
                                        }
                                    },
                                    {
                                        "exact_snippets": "previous continuous treatment with an EGFR TKI, e.g., gefitinib or erlotinib",
                                        "criterion": "previous treatment",
                                        "requirement": {
                                            "requirement_type": "type",
                                            "expected_value": "EGFR TKI"
                                        }
                                    },
                                    {
                                        "exact_snippets": "previous continuous treatment with an EGFR TKI, e.g., gefitinib or erlotinib",
                                        "criterion": "previous treatment",
                                        "requirement": {
                                            "requirement_type": "continuity",
                                            "expected_value": "continuous"
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "other lines of therapy may have been given(chemotherapy only accept first line)",
                                        "criterion": "lines of therapy",
                                        "requirement": {
                                            "requirement_type": "type",
                                            "expected_value": "chemotherapy"
                                        }
                                    },
                                    {
                                        "exact_snippets": "other lines of therapy may have been given(chemotherapy only accept first line)",
                                        "criterion": "lines of therapy",
                                        "requirement": {
                                            "requirement_type": "line",
                                            "expected_value": "first"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Confirmation that the tumor harbors an EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q) or must have experienced clinical benefit from EGFR TKI, according to the Jackman criteria while on continuous treatment with an EGFR TKI(PR/CR、or SD continued ≥6 months).",
                "criterions": [
                    {
                        "exact_snippets": "tumor harbors an EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q)",
                        "criterion": "EGFR mutation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "G719X",
                                "exon 19 deletion",
                                "L858R",
                                "L861Q"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "must have experienced clinical benefit from EGFR TKI, according to the Jackman criteria",
                        "criterion": "clinical benefit from EGFR TKI",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "while on continuous treatment with an EGFR TKI(PR/CR、or SD continued ≥6 months)",
                        "criterion": "continuous treatment with an EGFR TKI",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "tumor harbors an EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q)",
                                "criterion": "EGFR mutation",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": [
                                        "G719X",
                                        "exon 19 deletion",
                                        "L858R",
                                        "L861Q"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "while on continuous treatment with an EGFR TKI(PR/CR、or SD continued ≥6 months)",
                                "criterion": "continuous treatment with an EGFR TKI",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "must have experienced clinical benefit from EGFR TKI, according to the Jackman criteria",
                                "criterion": "clinical benefit from EGFR TKI",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "while on continuous treatment with an EGFR TKI(PR/CR、or SD continued ≥6 months)",
                                "criterion": "continuous treatment with an EGFR TKI",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Patients must have confirmation of tumor T790M+ mutation status.",
                "criterions": [
                    {
                        "exact_snippets": "confirmation of tumor T790M+ mutation status",
                        "criterion": "tumor T790M+ mutation status",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "confirmation of tumor T790M+ mutation status",
                        "criterion": "tumor T790M+ mutation status",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Patients also must have confirmation of tumor T790M+ mutation status.",
                "criterions": [
                    {
                        "exact_snippets": "confirmation of tumor T790M+ mutation status",
                        "criterion": "tumor T790M+ mutation status",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "confirmation of tumor T790M+ mutation status",
                        "criterion": "tumor T790M+ mutation status",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. World Health Organization (WHO) performance status equal to 0-1 with no deterioration over the previous 2 weeks.",
                "criterions": [
                    {
                        "exact_snippets": "World Health Organization (WHO) performance status equal to 0-1",
                        "criterion": "WHO performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "no deterioration over the previous 2 weeks",
                        "criterion": "performance status deterioration",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "World Health Organization (WHO) performance status equal to 0-1",
                        "criterion": "WHO performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "no deterioration over the previous 2 weeks",
                        "criterion": "performance status deterioration",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. A minimum life expectancy of 12 weeks.",
                "criterions": [
                    {
                        "exact_snippets": "minimum life expectancy of 12 weeks",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum life expectancy of 12 weeks",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "13. Do not anticipate other clinical trail in 3 months.",
                "criterions": [
                    {
                        "exact_snippets": "Do not anticipate other clinical trail in 3 months.",
                        "criterion": "participation in other clinical trial",
                        "requirement": {
                            "requirement_type": "anticipation",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Do not anticipate other clinical trail in 3 months.",
                        "criterion": "participation in other clinical trial",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Do not anticipate other clinical trail in 3 months.",
                        "criterion": "participation in other clinical trial",
                        "requirement": {
                            "requirement_type": "anticipation",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Do not anticipate other clinical trail in 3 months.",
                        "criterion": "participation in other clinical trial",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "14. The patient must provide a written informed consent for genetic research.",
                "criterions": [
                    {
                        "exact_snippets": "written informed consent for genetic research",
                        "criterion": "written informed consent for genetic research",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "written informed consent for genetic research",
                        "criterion": "written informed consent for genetic research",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 75 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 75 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 75 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "1. Not Confirmed by pathology.",
                "criterions": [
                    {
                        "exact_snippets": "Not Confirmed by pathology",
                        "criterion": "pathology confirmation",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Not Confirmed by pathology",
                        "criterion": "pathology confirmation",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. An EGFR TKI within 8 days or approximately 5 times the half-life of the specific drug, whichever is longer, of the first dose of study treatment.",
                "criterions": [
                    {
                        "exact_snippets": "EGFR TKI within 8 days or approximately 5 times the half-life of the specific drug, whichever is longer",
                        "criterion": "EGFR TKI administration",
                        "requirement": {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 8,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "EGFR TKI within 8 days or approximately 5 times the half-life of the specific drug, whichever is longer",
                    "criterion": "EGFR TKI administration",
                    "requirement": {
                        "requirement_type": "time since last administration",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 8,
                                    "unit": "days"
                                }
                            ]
                        }
                    }
                },
                "then_criteria": {
                    "exact_snippets": "EGFR TKI within 8 days or approximately 5 times the half-life of the specific drug, whichever is longer",
                    "criterion": "EGFR TKI administration",
                    "requirement": {
                        "requirement_type": "time since last administration",
                        "expected_value": "approximately 5 times the half-life of the specific drug"
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "3. Any cytotoxic chemotherapy used for a previous treatment regimen or clinical study within 21 days of the first dose of study treatment; Any target medicines used for a previous treatment regimen or clinical study within 14 days of the first dose of study treatment; withdrawal other clinical drugs or anti-cancer drugs less than 5 times the half-life.",
                "criterions": [
                    {
                        "exact_snippets": "cytotoxic chemotherapy used for a previous treatment regimen or clinical study within 21 days of the first dose of study treatment",
                        "criterion": "cytotoxic chemotherapy",
                        "requirement": {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": "<",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "target medicines used for a previous treatment regimen or clinical study within 14 days of the first dose of study treatment",
                        "criterion": "target medicines",
                        "requirement": {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": "<",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "withdrawal other clinical drugs or anti-cancer drugs less than 5 times the half-life",
                        "criterion": "other clinical drugs or anti-cancer drugs",
                        "requirement": {
                            "requirement_type": "time since withdrawal",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "times the half-life"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "cytotoxic chemotherapy used for a previous treatment regimen or clinical study within 21 days of the first dose of study treatment",
                                "criterion": "cytotoxic chemotherapy",
                                "requirement": {
                                    "requirement_type": "time since last use",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 21,
                                        "unit": "days"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "target medicines used for a previous treatment regimen or clinical study within 14 days of the first dose of study treatment",
                                "criterion": "target medicines",
                                "requirement": {
                                    "requirement_type": "time since last use",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 14,
                                        "unit": "days"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "withdrawal other clinical drugs or anti-cancer drugs less than 5 times the half-life",
                                "criterion": "other clinical drugs or anti-cancer drugs",
                                "requirement": {
                                    "requirement_type": "time since withdrawal",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 5,
                                        "unit": "times the half-life"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Ever used the third EGFR-TKI, such as AZD9291,CO-1686 or avitinib.",
                "criterions": [
                    {
                        "exact_snippets": "Ever used the third EGFR-TKI, such as AZD9291,CO-1686 or avitinib.",
                        "criterion": "use of third EGFR-TKI",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Ever used the third EGFR-TKI, such as AZD9291,CO-1686 or avitinib.",
                        "criterion": "use of third EGFR-TKI",
                        "requirement": {
                            "requirement_type": "examples",
                            "expected_value": [
                                "AZD9291",
                                "CO-1686",
                                "avitinib"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Ever used the third EGFR-TKI, such as AZD9291,CO-1686 or avitinib.",
                        "criterion": "use of third EGFR-TKI",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Ever used the third EGFR-TKI, such as AZD9291,CO-1686 or avitinib.",
                        "criterion": "use of third EGFR-TKI",
                        "requirement": {
                            "requirement_type": "examples",
                            "expected_value": [
                                "AZD9291",
                                "CO-1686",
                                "avitinib"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Major surgery within 4 weeks of the first dose of study treatment.",
                "criterions": [
                    {
                        "exact_snippets": "Major surgery within 4 weeks of the first dose of study treatment.",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Major surgery within 4 weeks of the first dose of study treatment.",
                    "criterion": "major surgery",
                    "requirement": {
                        "requirement_type": "time since surgery",
                        "expected_value": {
                            "operator": "<",
                            "value": 4,
                            "unit": "weeks"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "6. Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment, with the exception of patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation which must be completed within 4 weeks of the first dose of study treatment.",
                "criterions": [
                    {
                        "exact_snippets": "Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment",
                        "criterion": "radiotherapy timing",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    },
                    {
                        "exact_snippets": "patients receiving radiation to more than 30% of the bone marrow",
                        "criterion": "bone marrow radiation",
                        "requirement": {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "wide field of radiation which must be completed within 4 weeks of the first dose of study treatment",
                        "criterion": "wide field radiation timing",
                        "requirement": {
                            "requirement_type": "completion timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment",
                                    "criterion": "radiotherapy timing",
                                    "requirement": {
                                        "requirement_type": "timing",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 1,
                                            "unit": "week"
                                        }
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "or_criteria": [
                                            {
                                                "exact_snippets": "patients receiving radiation to more than 30% of the bone marrow",
                                                "criterion": "bone marrow radiation",
                                                "requirement": {
                                                    "requirement_type": "percentage",
                                                    "expected_value": {
                                                        "operator": ">",
                                                        "value": 30,
                                                        "unit": "%"
                                                    }
                                                }
                                            },
                                            {
                                                "exact_snippets": "wide field of radiation which must be completed within 4 weeks of the first dose of study treatment",
                                                "criterion": "wide field radiation timing",
                                                "requirement": {
                                                    "requirement_type": "completion timing",
                                                    "expected_value": {
                                                        "operator": "<=",
                                                        "value": 4,
                                                        "unit": "weeks"
                                                    }
                                                }
                                            }
                                        ]
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. The patient is currently using (or cannot discontinue at least 1 week before the first dose of study treatment) a drug or herbal supplement known as a potent inhibitor or inducer of CYP3A4.",
                "criterions": [
                    {
                        "exact_snippets": "The patient is currently using ... a drug or herbal supplement known as a potent inhibitor or inducer of CYP3A4.",
                        "criterion": "use of a drug or herbal supplement",
                        "requirement": {
                            "requirement_type": "CYP3A4 interaction",
                            "expected_value": [
                                "potent inhibitor",
                                "inducer"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "cannot discontinue at least 1 week before the first dose of study treatment ... a drug or herbal supplement known as a potent inhibitor or inducer of CYP3A4.",
                        "criterion": "ability to discontinue drug or herbal supplement",
                        "requirement": {
                            "requirement_type": "time before study treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "The patient is currently using ... a drug or herbal supplement known as a potent inhibitor or inducer of CYP3A4.",
                                "criterion": "use of a drug or herbal supplement",
                                "requirement": {
                                    "requirement_type": "CYP3A4 interaction",
                                    "expected_value": [
                                        "potent inhibitor",
                                        "inducer"
                                    ]
                                }
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "The patient is currently using ... a drug or herbal supplement known as a potent inhibitor or inducer of CYP3A4.",
                                        "criterion": "use of a drug or herbal supplement",
                                        "requirement": {
                                            "requirement_type": "CYP3A4 interaction",
                                            "expected_value": [
                                                "potent inhibitor",
                                                "inducer"
                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "cannot discontinue at least 1 week before the first dose of study treatment ... a drug or herbal supplement known as a potent inhibitor or inducer of CYP3A4.",
                                        "criterion": "ability to discontinue drug or herbal supplement",
                                        "requirement": {
                                            "requirement_type": "time before study treatment",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 1,
                                                "unit": "week"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Use large doses of glucocorticoids or other immunosuppressive agents within 4 weeks.",
                "criterions": [
                    {
                        "exact_snippets": "large doses of glucocorticoids",
                        "criterion": "glucocorticoid use",
                        "requirement": {
                            "requirement_type": "dose",
                            "expected_value": "large"
                        }
                    },
                    {
                        "exact_snippets": "large doses of glucocorticoids",
                        "criterion": "glucocorticoid use",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 4 weeks"
                        }
                    },
                    {
                        "exact_snippets": "other immunosuppressive agents",
                        "criterion": "immunosuppressive agent use",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 4 weeks"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "large doses of glucocorticoids",
                                "criterion": "glucocorticoid use",
                                "requirement": {
                                    "requirement_type": "dose",
                                    "expected_value": "large"
                                }
                            },
                            {
                                "exact_snippets": "large doses of glucocorticoids",
                                "criterion": "glucocorticoid use",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": "within 4 weeks"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "other immunosuppressive agents",
                        "criterion": "immunosuppressive agent use",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 4 weeks"
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "10. At least 1 lesion that has not previously been irradiated, that can be accurately measured at Baseline as ≥ 10mm in the longest diameter (except lymph nodes which must have short axis ≥ 15mm) with computerized tomography (CT) or magnetic resonance imaging (MRI), which is suitable for accurately repeated measurements.",
                "criterions": [
                    {
                        "exact_snippets": "At least 1 lesion that has not previously been irradiated",
                        "criterion": "lesion irradiation history",
                        "requirement": {
                            "requirement_type": "irradiation",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "At least 1 lesion ... that can be accurately measured at Baseline as ≥ 10mm in the longest diameter",
                        "criterion": "lesion size",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "lymph nodes which must have short axis ≥ 15mm",
                        "criterion": "lymph node size",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "mm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "with computerized tomography (CT) or magnetic resonance imaging (MRI)",
                        "criterion": "imaging method",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": [
                                "CT",
                                "MRI"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "suitable for accurately repeated measurements",
                        "criterion": "suitability for repeated measurements",
                        "requirement": {
                            "requirement_type": "suitability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "11. Females of child-bearing potential should be using adequate contraceptive measures throughout the study, should not be breast feeding during the study and until 6 months after completion of study, and must have a negative pregnancy test prior to start of dosing.",
                "criterions": [
                    {
                        "exact_snippets": "Females of child-bearing potential",
                        "criterion": "gender and reproductive potential",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female of child-bearing potential"
                        }
                    },
                    {
                        "exact_snippets": "using adequate contraceptive measures throughout the study",
                        "criterion": "contraceptive use",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "throughout the study"
                        }
                    },
                    {
                        "exact_snippets": "using adequate contraceptive measures throughout the study",
                        "criterion": "contraceptive use",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": "adequate"
                        }
                    },
                    {
                        "exact_snippets": "should not be breast feeding during the study and until 6 months after completion of study",
                        "criterion": "breastfeeding status",
                        "requirement": {
                            "requirement_type": "prohibition",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "should not be breast feeding during the study and until 6 months after completion of study",
                        "criterion": "breastfeeding status",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "during the study and until 6 months after completion of study"
                        }
                    },
                    {
                        "exact_snippets": "must have a negative pregnancy test prior to start of dosing",
                        "criterion": "pregnancy test result",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "must have a negative pregnancy test prior to start of dosing",
                        "criterion": "pregnancy test result",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "prior to start of dosing"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "12. Male patients should be willing to use barrier contraception during the study and until 6 months after completion of study (i.e., condoms).",
                "criterions": [
                    {
                        "exact_snippets": "Male patients should be willing to use barrier contraception during the study and until 6 months after completion of study (i.e., condoms).",
                        "criterion": "male patients",
                        "requirement": {
                            "requirement_type": "willingness to use barrier contraception",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "9. Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE), Grade 1, at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy.",
                "criterions": [
                    {
                        "exact_snippets": "unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE), Grade 1",
                        "criterion": "unresolved toxicities from prior therapy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "CTCAE Grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "alopecia",
                        "criterion": "alopecia",
                        "requirement": {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Grade 2, prior platinum-therapy related neuropathy",
                        "criterion": "prior platinum-therapy related neuropathy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "10. Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study treatment.",
                "criterions": [
                    {
                        "exact_snippets": "Spinal cord compression",
                        "criterion": "spinal cord compression",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "symptoms",
                            "expected_value": "asymptomatic"
                        }
                    },
                    {
                        "exact_snippets": "brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": "stable"
                        }
                    },
                    {
                        "exact_snippets": "brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "steroid requirement",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "duration without steroids",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "11. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension or active bleeding diatheses, which, in the Investigator's opinion, makes it undesirable for the patient to participate in the trial.",
                "criterions": [
                    {
                        "exact_snippets": "severe or uncontrolled systemic diseases",
                        "criterion": "systemic diseases",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "severe or uncontrolled systemic diseases",
                        "criterion": "systemic diseases",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled hypertension",
                        "criterion": "hypertension",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "active bleeding diatheses",
                        "criterion": "bleeding diatheses",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "12. Active infection (e.g., hepatitis B, hepatitis C or human immunodeficiency virus [HIV]). (HBsAg is positive but HBV-DNA <1×103 IU/ mL ,and HCVAb is positive but HCV-RNA<103 IU/mL can be accepted.）.",
                "criterions": [
                    {
                        "exact_snippets": "Active infection (e.g., hepatitis B, hepatitis C or human immunodeficiency virus [HIV])",
                        "criterion": "active infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "HBsAg is positive but HBV-DNA <1×103 IU/ mL",
                        "criterion": "HBV-DNA",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "HBsAg is positive but HBV-DNA <1×103 IU/ mL",
                        "criterion": "HBV-DNA",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1000,
                                "unit": "IU/mL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "HCVAb is positive but HCV-RNA<103 IU/mL",
                        "criterion": "HCV-RNA",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "HCVAb is positive but HCV-RNA<103 IU/mL",
                        "criterion": "HCV-RNA",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1000,
                                "unit": "IU/mL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "13. Any of the following cardiac criteria:",
                "criterions": [
                    {
                        "exact_snippets": "cardiac criteria",
                        "criterion": "cardiac criteria",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "1. Mean resting corrected QT interval (QTc) > 470 msec obtained from 3 electrocardiograms (ECGs), using the Screening clinic ECG machine and Fridericia's formula for QT interval correction.",
                "criterions": [
                    {
                        "exact_snippets": "Mean resting corrected QT interval (QTc) > 470 msec",
                        "criterion": "corrected QT interval (QTc)",
                        "requirement": {
                            "requirement_type": "mean value",
                            "expected_value": {
                                "operator": ">",
                                "value": 470,
                                "unit": "msec"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "2. Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG (e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval >250msec).",
                "criterions": [
                    {
                        "exact_snippets": "clinically important abnormalities in rhythm",
                        "criterion": "ECG rhythm",
                        "requirement": {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "clinically important abnormalities in ... conduction",
                        "criterion": "ECG conduction",
                        "requirement": {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "clinically important abnormalities in ... morphology of the resting ECG",
                        "criterion": "ECG morphology",
                        "requirement": {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "complete left bundle branch block",
                        "criterion": "left bundle branch block",
                        "requirement": {
                            "requirement_type": "completeness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "third-degree heart block",
                        "criterion": "heart block",
                        "requirement": {
                            "requirement_type": "degree",
                            "expected_value": "third-degree"
                        }
                    },
                    {
                        "exact_snippets": "second-degree heart block",
                        "criterion": "heart block",
                        "requirement": {
                            "requirement_type": "degree",
                            "expected_value": "second-degree"
                        }
                    },
                    {
                        "exact_snippets": "PR interval >250msec",
                        "criterion": "PR interval",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 250,
                                "unit": "msec"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "3. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval.",
                "criterions": [
                    {
                        "exact_snippets": "factors that increase the risk of QTc prolongation",
                        "criterion": "risk of QTc prolongation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "risk of arrhythmic events",
                        "criterion": "risk of arrhythmic events",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "heart failure",
                        "criterion": "heart failure",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "hypokalemia",
                        "criterion": "hypokalemia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "congenital long QT syndrome",
                        "criterion": "congenital long QT syndrome",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "family history of long QT syndrome",
                        "criterion": "family history of long QT syndrome",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "unexplained sudden death under 40 years of age in first degree relatives",
                        "criterion": "unexplained sudden death under 40 years of age in first degree relatives",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "any concomitant medication known to prolong the QT interval",
                        "criterion": "concomitant medication known to prolong the QT interval",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "14. Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.",
                "criterions": [
                    {
                        "exact_snippets": "Past medical history of interstitial lung disease",
                        "criterion": "interstitial lung disease",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Past medical history of ... drug-induced interstitial lung disease",
                        "criterion": "drug-induced interstitial lung disease",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Past medical history of ... radiation pneumonitis which required steroid treatment",
                        "criterion": "radiation pneumonitis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Past medical history of ... radiation pneumonitis which required steroid treatment",
                        "criterion": "radiation pneumonitis",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "steroid"
                        }
                    },
                    {
                        "exact_snippets": "any evidence of clinically active interstitial lung disease",
                        "criterion": "clinically active interstitial lung disease",
                        "requirement": {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "15. Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:",
                "criterions": [
                    {
                        "exact_snippets": "Inadequate bone marrow reserve",
                        "criterion": "bone marrow reserve",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Inadequate ... organ function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "1. Absolute neutrophil count < 1.5 x 109/L.",
                "criterions": [
                    {
                        "exact_snippets": "Absolute neutrophil count < 1.5 x 109/L",
                        "criterion": "absolute neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x 109/L"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "2. Platelet count < 100 x 109/L.",
                "criterions": [
                    {
                        "exact_snippets": "Platelet count < 100 x 109/L",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 100,
                                "unit": "x 109/L"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "3. Hemoglobin < 90 g/L (< 9 g/dL).",
                "criterions": [
                    {
                        "exact_snippets": "Hemoglobin < 90 g/L (< 9 g/dL)",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 90,
                                        "unit": "g/L"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 9,
                                        "unit": "g/dL"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "4. Alanine aminotransferase > 2.5 times the upper limit of normal (ULN) if no demonstrable liver metastases or > 5 times the ULN in the presence of liver metastases.",
                "criterions": [
                    {
                        "exact_snippets": "Alanine aminotransferase > 2.5 times the upper limit of normal (ULN) if no demonstrable liver metastases",
                        "criterion": "alanine aminotransferase",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.5,
                                "unit": "times the upper limit of normal (ULN)"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Alanine aminotransferase ... > 5 times the ULN in the presence of liver metastases",
                        "criterion": "alanine aminotransferase",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "times the ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "5. Aspartate aminotransferase > 2.5 times the ULN if no demonstrable liver metastases or > 5 times the ULN in the presence of liver metastases.",
                "criterions": [
                    {
                        "exact_snippets": "Aspartate aminotransferase > 2.5 times the ULN if no demonstrable liver metastases",
                        "criterion": "aspartate aminotransferase",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.5,
                                "unit": "times the ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Aspartate aminotransferase > 2.5 times the ULN if no demonstrable liver metastases",
                        "criterion": "aspartate aminotransferase",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "no demonstrable liver metastases"
                        }
                    },
                    {
                        "exact_snippets": "Aspartate aminotransferase ... > 5 times the ULN in the presence of liver metastases",
                        "criterion": "aspartate aminotransferase",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "times the ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Aspartate aminotransferase ... > 5 times the ULN in the presence of liver metastases",
                        "criterion": "aspartate aminotransferase",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "presence of liver metastases"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "7. Creatinine > 1.5 times the ULN concurrent with creatinine clearance < 50 mL/min (measured or calculated by the Cockcroft - Gault equation); confirmation of creatinine clearance is only required when creatinine is > 1.5 times the ULN.",
                "criterions": [
                    {
                        "exact_snippets": "Creatinine > 1.5 times the ULN",
                        "criterion": "creatinine level",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "times the ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "creatinine clearance < 50 mL/min",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "16. Have any other malignant tumor within five years (except clinically cured cervical carcinoma in situ, basal cells or squamous epithelial skin cancer).",
                "criterions": [
                    {
                        "exact_snippets": "Have any other malignant tumor within five years",
                        "criterion": "malignant tumor",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Have any other malignant tumor within five years",
                        "criterion": "malignant tumor",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "except clinically cured cervical carcinoma in situ",
                        "criterion": "cervical carcinoma in situ",
                        "requirement": {
                            "requirement_type": "clinical status",
                            "expected_value": "clinically cured"
                        }
                    },
                    {
                        "exact_snippets": "except ... basal cells or squamous epithelial skin cancer",
                        "criterion": "basal cells or squamous epithelial skin cancer",
                        "requirement": {
                            "requirement_type": "clinical status",
                            "expected_value": "clinically cured"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "17. Refractory nausea, vomiting, or chronic gastrointestinal diseases, inability to swallow the study medication, or previous significant bowel resection that would preclude adequate absorption of SH-1028.",
                "criterions": [
                    {
                        "exact_snippets": "Refractory nausea, vomiting, or chronic gastrointestinal diseases",
                        "criterion": "gastrointestinal condition",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "refractory nausea",
                                "vomiting",
                                "chronic gastrointestinal diseases"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "inability to swallow the study medication",
                        "criterion": "ability to swallow medication",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "previous significant bowel resection that would preclude adequate absorption of SH-1028",
                        "criterion": "bowel resection",
                        "requirement": {
                            "requirement_type": "impact on absorption",
                            "expected_value": "preclude adequate absorption of SH-1028"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "18. History of hypersensitivity to any active or inactive ingredient of SH-1028 or to a drug with a similar chemical structure or class to SH-1028.",
                "criterions": [
                    {
                        "exact_snippets": "History of hypersensitivity to any active or inactive ingredient of SH-1028",
                        "criterion": "hypersensitivity to SH-1028 ingredients",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "hypersensitivity ... to a drug with a similar chemical structure or class to SH-1028",
                        "criterion": "hypersensitivity to similar drugs",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "19. Women who are breast feeding.",
                "criterions": [
                    {
                        "exact_snippets": "Women who are breast feeding",
                        "criterion": "breast feeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "20. Any disease or condition that, in the opinion of the Investigator, would compromise the safety of the patient or interfere with study assessments.",
                "criterions": [
                    {
                        "exact_snippets": "Any disease or condition ... would compromise the safety of the patient",
                        "criterion": "disease or condition",
                        "requirement": {
                            "requirement_type": "safety risk",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Any disease or condition ... interfere with study assessments",
                        "criterion": "disease or condition",
                        "requirement": {
                            "requirement_type": "interference with study assessments",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "6. Total bilirubin > 1.5 times the ULN if no liver metastases or > 3 times the ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases.",
                "criterions": [
                    {
                        "exact_snippets": "Total bilirubin > 1.5 times the ULN if no liver metastases",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "times the ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Total bilirubin > 1.5 times the ULN if no liver metastases",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "no liver metastases"
                        }
                    },
                    {
                        "exact_snippets": "Total bilirubin > 3 times the ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "times the ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Total bilirubin > 3 times the ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": [
                                "documented Gilbert's Syndrome (unconjugated hyperbilirubinemia)",
                                "liver metastases"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_miscellaneous": []
}