{
    "info": {
        "nct_id": "NCT01993472",
        "official_title": "Andrographolides With or Without Capecitabine for Elderly Patients With Locally Advanced or Recurrent or Metastasis Inoperable Colorectal Cancer: a Randomized, Open-label Trial.",
        "inclusion_criteria": "1. Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum\n2. Locally advanced or recurrent or metastasis inoperable disease\n3. At least 1 measurable or non-measurable lesion per RECIST version 1.1 guidelines. Lesion must not be chosen from a previously irradiated field unless there had been documented tumor progression in that lesion prior to randomization. All sites of disease must be evaluated ≤ 28 days prior to randomization.\n4. Man or woman ≥ 65 years of age\n5. Hematological function, as follow: (≤ 10 days prior to randomization)\n\n   * Absolute neutrophil count (ANC) ≥ 1.5×109/L\n   * Platelet count ≥ 75×109/L\n   * Hemoglobin ≥ 8.0 g/dL\n6. Renal function, as follows: (≤ 10 days prior to randomization)\n\n   * Creatinine≤ 1.5×ULN\n7. Hepatic function, as follow: (≤ 10 days prior to randomization)\n\n   * Aspartate aminotransferase (AST) ≤ 3×ULN(if liver metastases≤ 5×ULN )\n   * Alanine aminotransferase (ALT) ≤ 3×ULN(if liver metastases≤ 5×ULN )\n   * Total bilirubin≤ 1.5×ULN\n8. Subject or subject's legally acceptable representative has provided informed consent\nHealthy volunteers allowed\nMust have minimum age of 65 Years",
        "exclusion_criteria": "1. Symptomatic brain metastases requiring treatment\n2. History of other malignancy, except:\n\n   * Malignancy treated with curative intent and with no known active disease present for ≥ 5 years prior to randomization and felt to be at low risk for recurrence by the treating physician\n   * Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease\n   * Adequately treated cervical carcinoma in situ without evidence of disease\n   * Prostatic intraepithelial neoplasia without evidence of prostate cancer\n3. Antitumor therapy(eg, chemotherapy, hormonal therapy, immunotherapy, antibody therapy) ≤ 21 days before randomization. Subjects must have recovered from any acute radiotherapy-related toxicity\n4. Radiotherapy≤ 14 days before randomization. Subjects must have recovered from any acute radiotherapy-related toxicities\n5. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia)≤ 6 months prior to randomization\n6. History of interstitial lung disease(ILD) eg, interstitial pneumonitis, pulmonary fibrosis or evidence of ILD on baseline chest CT or MRI\n7. History of any medical or psychiatric condition or labortory abnomality that in the opinion of the investigator may increase the risk associated with the study participation or investigational product administration or may interfere with the interpretation of the results\n8. Unstable pulmonary embolism, deep vein thrombosis, or other significant arterial/venous thromboembolic event ≤ 30 days before randomization. If on anticoagulation, subject must be on stable therapeutic dose prior to rangdomization.\n9. Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures or is unwilling or unable to comply with study requirements",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Absolute neutrophil count (ANC) ≥ 1.5×109/L",
                "criterions": [
                    {
                        "exact_snippets": "Absolute neutrophil count (ANC) ≥ 1.5×109/L",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "×10^9/L"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Absolute neutrophil count (ANC) ≥ 1.5×109/L",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "×10^9/L"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Platelet count ≥ 75×109/L",
                "criterions": [
                    {
                        "exact_snippets": "Platelet count ≥ 75×109/L",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 75,
                                "unit": "×10^9/L"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Platelet count ≥ 75×109/L",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 75,
                                "unit": "×10^9/L"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Hemoglobin ≥ 8.0 g/dL",
                "criterions": [
                    {
                        "exact_snippets": "Hemoglobin ≥ 8.0 g/dL",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8.0,
                                "unit": "g/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hemoglobin ≥ 8.0 g/dL",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8.0,
                                "unit": "g/dL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Creatinine≤ 1.5×ULN",
                "criterions": [
                    {
                        "exact_snippets": "Creatinine≤ 1.5×ULN",
                        "criterion": "creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Creatinine≤ 1.5×ULN",
                        "criterion": "creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Aspartate aminotransferase (AST) ≤ 3×ULN(if liver metastases≤ 5×ULN )",
                "criterions": [
                    {
                        "exact_snippets": "Aspartate aminotransferase (AST) ≤ 3×ULN",
                        "criterion": "aspartate aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "if liver metastases≤ 5×ULN",
                        "criterion": "aspartate aminotransferase (AST) with liver metastases",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "if liver metastases≤ 5×ULN",
                    "criterion": "aspartate aminotransferase (AST) with liver metastases",
                    "requirement": {
                        "requirement_type": "level",
                        "expected_value": {
                            "operator": "<=",
                            "value": 5,
                            "unit": "ULN"
                        }
                    }
                },
                "then_criteria": {
                    "exact_snippets": "Aspartate aminotransferase (AST) ≤ 3×ULN",
                    "criterion": "aspartate aminotransferase (AST)",
                    "requirement": {
                        "requirement_type": "level",
                        "expected_value": {
                            "operator": "<=",
                            "value": 3,
                            "unit": "ULN"
                        }
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Alanine aminotransferase (ALT) ≤ 3×ULN(if liver metastases≤ 5×ULN )",
                "criterions": [
                    {
                        "exact_snippets": "Alanine aminotransferase (ALT) ≤ 3×ULN",
                        "criterion": "Alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "liver metastases≤ 5×ULN",
                        "criterion": "Alanine aminotransferase (ALT) with liver metastases",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "liver metastases≤ 5×ULN",
                    "criterion": "Alanine aminotransferase (ALT) with liver metastases",
                    "requirement": {
                        "requirement_type": "level",
                        "expected_value": {
                            "operator": "<=",
                            "value": 5,
                            "unit": "ULN"
                        }
                    }
                },
                "then_criteria": {
                    "exact_snippets": "Alanine aminotransferase (ALT) ≤ 3×ULN",
                    "criterion": "Alanine aminotransferase (ALT)",
                    "requirement": {
                        "requirement_type": "level",
                        "expected_value": {
                            "operator": "<=",
                            "value": 5,
                            "unit": "ULN"
                        }
                    }
                },
                "else_criteria": {
                    "exact_snippets": "Alanine aminotransferase (ALT) ≤ 3×ULN",
                    "criterion": "Alanine aminotransferase (ALT)",
                    "requirement": {
                        "requirement_type": "level",
                        "expected_value": {
                            "operator": "<=",
                            "value": 3,
                            "unit": "ULN"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Total bilirubin≤ 1.5×ULN",
                "criterions": [
                    {
                        "exact_snippets": "Total bilirubin≤ 1.5×ULN",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Total bilirubin≤ 1.5×ULN",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Subject or subject's legally acceptable representative has provided informed consent",
                "criterions": [
                    {
                        "exact_snippets": "Subject or subject's legally acceptable representative has provided informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Subject or subject's legally acceptable representative has provided informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "provision",
                            "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 65 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 65 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 65,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 65 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 65,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "1. Symptomatic brain metastases requiring treatment",
                "criterions": [
                    {
                        "exact_snippets": "Symptomatic brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "requiring treatment",
                        "criterion": "treatment requirement",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Symptomatic brain metastases",
                                "criterion": "brain metastases",
                                "requirement": {
                                    "requirement_type": "symptomatic",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "requiring treatment",
                                "criterion": "treatment requirement",
                                "requirement": {
                                    "requirement_type": "necessity",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. History of other malignancy, except:",
                "criterions": [
                    {
                        "exact_snippets": "History of other malignancy",
                        "criterion": "history of other malignancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "History of other malignancy",
                                    "criterion": "history of other malignancy",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Malignancy treated with curative intent and with no known active disease present for ≥ 5 years prior to randomization and felt to be at low risk for recurrence by the treating physician",
                "criterions": [
                    {
                        "exact_snippets": "Malignancy treated with curative intent",
                        "criterion": "malignancy treatment intent",
                        "requirement": {
                            "requirement_type": "intent",
                            "expected_value": "curative"
                        }
                    },
                    {
                        "exact_snippets": "no known active disease present for ≥ 5 years prior to randomization",
                        "criterion": "active disease presence",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "no known active disease present for ≥ 5 years prior to randomization",
                        "criterion": "active disease presence",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "felt to be at low risk for recurrence by the treating physician",
                        "criterion": "recurrence risk",
                        "requirement": {
                            "requirement_type": "risk level",
                            "expected_value": "low"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "Malignancy treated with curative intent",
                                                "criterion": "malignancy treatment intent",
                                                "requirement": {
                                                    "requirement_type": "intent",
                                                    "expected_value": "curative"
                                                }
                                            },
                                            {
                                                "exact_snippets": "no known active disease present for ≥ 5 years prior to randomization",
                                                "criterion": "active disease presence",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": false
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "no known active disease present for ≥ 5 years prior to randomization",
                                        "criterion": "active disease presence",
                                        "requirement": {
                                            "requirement_type": "duration",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 5,
                                                "unit": "years"
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "felt to be at low risk for recurrence by the treating physician",
                                "criterion": "recurrence risk",
                                "requirement": {
                                    "requirement_type": "risk level",
                                    "expected_value": "low"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease",
                "criterions": [
                    {
                        "exact_snippets": "Adequately treated non-melanomatous skin cancer",
                        "criterion": "non-melanomatous skin cancer",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    },
                    {
                        "exact_snippets": "lentigo maligna without evidence of disease",
                        "criterion": "lentigo maligna",
                        "requirement": {
                            "requirement_type": "disease evidence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequately treated non-melanomatous skin cancer",
                        "criterion": "non-melanomatous skin cancer",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    },
                    {
                        "exact_snippets": "lentigo maligna without evidence of disease",
                        "criterion": "lentigo maligna",
                        "requirement": {
                            "requirement_type": "disease evidence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adequately treated cervical carcinoma in situ without evidence of disease",
                "criterions": [
                    {
                        "exact_snippets": "Adequately treated cervical carcinoma in situ",
                        "criterion": "cervical carcinoma in situ",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    },
                    {
                        "exact_snippets": "without evidence of disease",
                        "criterion": "evidence of disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequately treated cervical carcinoma in situ",
                        "criterion": "cervical carcinoma in situ",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    },
                    {
                        "exact_snippets": "without evidence of disease",
                        "criterion": "evidence of disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Prostatic intraepithelial neoplasia without evidence of prostate cancer",
                "criterions": [
                    {
                        "exact_snippets": "Prostatic intraepithelial neoplasia",
                        "criterion": "prostatic intraepithelial neoplasia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "without evidence of prostate cancer",
                        "criterion": "prostate cancer",
                        "requirement": {
                            "requirement_type": "evidence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Prostatic intraepithelial neoplasia",
                        "criterion": "prostatic intraepithelial neoplasia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "without evidence of prostate cancer",
                        "criterion": "prostate cancer",
                        "requirement": {
                            "requirement_type": "evidence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia)≤ 6 months prior to randomization",
                "criterions": [
                    {
                        "exact_snippets": "Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia)",
                        "criterion": "clinically significant cardiovascular disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "≤ 6 months prior to randomization",
                        "criterion": "time since cardiovascular event",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "exact_snippets": "Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia)",
                            "criterion": "clinically significant cardiovascular disease",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        },
                        {
                            "exact_snippets": "≤ 6 months prior to randomization",
                            "criterion": "time since cardiovascular event",
                            "requirement": {
                                "requirement_type": "duration",
                                "expected_value": {
                                    "operator": "<=",
                                    "value": 6,
                                    "unit": "months"
                                }
                            }
                        }
                    ]
                },
                "then_criteria": {
                    "exact_snippets": "Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia)",
                    "criterion": "clinically significant cardiovascular disease",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "7. History of any medical or psychiatric condition or labortory abnomality that in the opinion of the investigator may increase the risk associated with the study participation or investigational product administration or may interfere with the interpretation of the results",
                "criterions": [
                    {
                        "exact_snippets": "History of any medical or psychiatric condition",
                        "criterion": "medical or psychiatric condition",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "labortory abnomality",
                        "criterion": "laboratory abnormality",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "History of any medical or psychiatric condition",
                                        "criterion": "medical or psychiatric condition",
                                        "requirement": {
                                            "requirement_type": "history",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "in the opinion of the investigator may increase the risk associated with the study participation or investigational product administration or may interfere with the interpretation of the results",
                                        "criterion": "investigator's opinion on risk or interference",
                                        "requirement": {
                                            "requirement_type": "opinion",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "labortory abnomality",
                                        "criterion": "laboratory abnormality",
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                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "in the opinion of the investigator may increase the risk associated with the study participation or investigational product administration or may interfere with the interpretation of the results",
                                        "criterion": "investigator's opinion on risk or interference",
                                        "requirement": {
                                            "requirement_type": "opinion",
                                            "expected_value": true
                                        }
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                        ]
                    }
                ]
            }
        },
        {
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                "line": "8. Unstable pulmonary embolism, deep vein thrombosis, or other significant arterial/venous thromboembolic event ≤ 30 days before randomization. If on anticoagulation, subject must be on stable therapeutic dose prior to rangdomization.",
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                    {
                        "exact_snippets": "Unstable pulmonary embolism",
                        "criterion": "pulmonary embolism",
                        "requirement": {
                            "requirement_type": "stability",
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                        }
                    },
                    {
                        "exact_snippets": "deep vein thrombosis",
                        "criterion": "deep vein thrombosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "other significant arterial/venous thromboembolic event",
                        "criterion": "arterial/venous thromboembolic event",
                        "requirement": {
                            "requirement_type": "significance",
                            "expected_value": "significant"
                        }
                    },
                    {
                        "exact_snippets": "≤ 30 days before randomization",
                        "criterion": "time since thromboembolic event",
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                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "If on anticoagulation, subject must be on stable therapeutic dose",
                        "criterion": "anticoagulation therapy",
                        "requirement": {
                            "requirement_type": "dose stability",
                            "expected_value": "stable therapeutic dose"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "and_criteria": [
                                                    {
                                                        "exact_snippets": "Unstable pulmonary embolism",
                                                        "criterion": "pulmonary embolism",
                                                        "requirement": {
                                                            "requirement_type": "stability",
                                                            "expected_value": "unstable"
                                                        }
                                                    },
                                                    {
                                                        "exact_snippets": "≤ 30 days before randomization",
                                                        "criterion": "time since thromboembolic event",
                                                        "requirement": {
                                                            "requirement_type": "time since event",
                                                            "expected_value": {
                                                                "operator": "<=",
                                                                "value": 30,
                                                                "unit": "days"
                                                            }
                                                        }
                                                    }
                                                ]
                                            },
                                            {
                                                "exact_snippets": "If on anticoagulation, subject must be on stable therapeutic dose",
                                                "criterion": "anticoagulation therapy",
                                                "requirement": {
                                                    "requirement_type": "dose stability",
                                                    "expected_value": "stable therapeutic dose"
                                                }
                                            }
                                        ]
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "deep vein thrombosis",
                                                "criterion": "deep vein thrombosis",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": true
                                                }
                                            },
                                            {
                                                "exact_snippets": "≤ 30 days before randomization",
                                                "criterion": "time since thromboembolic event",
                                                "requirement": {
                                                    "requirement_type": "time since event",
                                                    "expected_value": {
                                                        "operator": "<=",
                                                        "value": 30,
                                                        "unit": "days"
                                                    }
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "If on anticoagulation, subject must be on stable therapeutic dose",
                                        "criterion": "anticoagulation therapy",
                                        "requirement": {
                                            "requirement_type": "dose stability",
                                            "expected_value": "stable therapeutic dose"
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "other significant arterial/venous thromboembolic event",
                                                "criterion": "arterial/venous thromboembolic event",
                                                "requirement": {
                                                    "requirement_type": "significance",
                                                    "expected_value": "significant"
                                                }
                                            },
                                            {
                                                "exact_snippets": "≤ 30 days before randomization",
                                                "criterion": "time since thromboembolic event",
                                                "requirement": {
                                                    "requirement_type": "time since event",
                                                    "expected_value": {
                                                        "operator": "<=",
                                                        "value": 30,
                                                        "unit": "days"
                                                    }
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "If on anticoagulation, subject must be on stable therapeutic dose",
                                        "criterion": "anticoagulation therapy",
                                        "requirement": {
                                            "requirement_type": "dose stability",
                                            "expected_value": "stable therapeutic dose"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "1. Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum",
                "criterions": [
                    {
                        "exact_snippets": "Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum",
                        "criterion": "adenocarcinoma diagnosis",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum",
                        "criterion": "adenocarcinoma diagnosis",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": [
                                "colon",
                                "rectum"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "2. Locally advanced or recurrent or metastasis inoperable disease",
                "criterions": [
                    {
                        "exact_snippets": "Locally advanced",
                        "criterion": "disease stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "locally advanced"
                        }
                    },
                    {
                        "exact_snippets": "recurrent",
                        "criterion": "disease status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "recurrent"
                        }
                    },
                    {
                        "exact_snippets": "metastasis inoperable",
                        "criterion": "disease operability",
                        "requirement": {
                            "requirement_type": "operability",
                            "expected_value": "inoperable"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "3. At least 1 measurable or non-measurable lesion per RECIST version 1.1 guidelines. Lesion must not be chosen from a previously irradiated field unless there had been documented tumor progression in that lesion prior to randomization. All sites of disease must be evaluated ≤ 28 days prior to randomization.",
                "criterions": [
                    {
                        "exact_snippets": "At least 1 measurable or non-measurable lesion per RECIST version 1.1 guidelines.",
                        "criterion": "lesion",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    },
                    {
                        "exact_snippets": "At least 1 measurable or non-measurable lesion per RECIST version 1.1 guidelines.",
                        "criterion": "lesion",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "non-measurable"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Lesion must not be chosen from a previously irradiated field unless there had been documented tumor progression in that lesion prior to randomization.",
                        "criterion": "lesion",
                        "requirement": {
                            "requirement_type": "irradiation status",
                            "expected_value": "not from a previously irradiated field unless documented tumor progression"
                        }
                    },
                    {
                        "exact_snippets": "All sites of disease must be evaluated ≤ 28 days prior to randomization.",
                        "criterion": "sites of disease",
                        "requirement": {
                            "requirement_type": "evaluation timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days prior to randomization"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
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            }
        },
        {
            "identified_line": {
                "line": "4. Man or woman ≥ 65 years of age",
                "criterions": [
                    {
                        "exact_snippets": "Man or woman ≥ 65 years of age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 65,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "5. Hematological function, as follow: (≤ 10 days prior to randomization)",
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                    {
                        "exact_snippets": "Hematological function",
                        "criterion": "hematological function",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "≤ 10 days prior to randomization"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "6. Renal function, as follows: (≤ 10 days prior to randomization)",
                "criterions": [
                    {
                        "exact_snippets": "Renal function",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "≤ 10 days prior to randomization"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Renal function",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "\u0010 days prior to randomization"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Hepatic function, as follow: (≤ 10 days prior to randomization)",
                "criterions": [
                    {
                        "exact_snippets": "Hepatic function",
                        "criterion": "hepatic function",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "≤ 10 days prior to randomization"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hepatic function",
                        "criterion": "hepatic function",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "\u0010 days prior to randomization"
                        }
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "3. Antitumor therapy(eg, chemotherapy, hormonal therapy, immunotherapy, antibody therapy) ≤ 21 days before randomization. Subjects must have recovered from any acute radiotherapy-related toxicity",
                "criterions": [
                    {
                        "exact_snippets": "Antitumor therapy(eg, chemotherapy, hormonal therapy, immunotherapy, antibody therapy) ≤ 21 days before randomization",
                        "criterion": "antitumor therapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Subjects must have recovered from any acute radiotherapy-related toxicity",
                        "criterion": "recovery from acute radiotherapy-related toxicity",
                        "requirement": {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
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                                "not_criteria": {
                                    "exact_snippets": "Antitumor therapy(eg, chemotherapy, hormonal therapy, immunotherapy, antibody therapy) \u0010 21 days before randomization",
                                    "criterion": "antitumor therapy",
                                    "requirement": {
                                        "requirement_type": "time since last treatment",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 21,
                                            "unit": "days"
                                        }
                                    }
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "Subjects must have recovered from any acute radiotherapy-related toxicity",
                                    "criterion": "recovery from acute radiotherapy-related toxicity",
                                    "requirement": {
                                        "requirement_type": "recovery",
                                        "expected_value": true
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Radiotherapy≤ 14 days before randomization. Subjects must have recovered from any acute radiotherapy-related toxicities",
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                    {
                        "exact_snippets": "Radiotherapy≤ 14 days before randomization",
                        "criterion": "radiotherapy timing",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Subjects must have recovered from any acute radiotherapy-related toxicities",
                        "criterion": "recovery from acute radiotherapy-related toxicities",
                        "requirement": {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "Radiotherapy\u001014 days before randomization",
                            "criterion": "radiotherapy timing",
                            "requirement": {
                                "requirement_type": "timing",
                                "expected_value": {
                                    "operator": "<=",
                                    "value": 14,
                                    "unit": "days"
                                }
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "Subjects must have recovered from any acute radiotherapy-related toxicities",
                            "criterion": "recovery from acute radiotherapy-related toxicities",
                            "requirement": {
                                "requirement_type": "recovery",
                                "expected_value": true
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. History of interstitial lung disease(ILD) eg, interstitial pneumonitis, pulmonary fibrosis or evidence of ILD on baseline chest CT or MRI",
                "criterions": [
                    {
                        "exact_snippets": "History of interstitial lung disease(ILD)",
                        "criterion": "interstitial lung disease (ILD)",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "evidence of ILD on baseline chest CT or MRI",
                        "criterion": "interstitial lung disease (ILD)",
                        "requirement": {
                            "requirement_type": "evidence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of interstitial lung disease(ILD)",
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                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "interstitial pneumonitis",
                                        "criterion": "interstitial pneumonitis",
                                        "requirement": {
                                            "requirement_type": "history",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "pulmonary fibrosis",
                                        "criterion": "pulmonary fibrosis",
                                        "requirement": {
                                            "requirement_type": "history",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "evidence of ILD on baseline chest CT or MRI",
                        "criterion": "interstitial lung disease (ILD)",
                        "requirement": {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures or is unwilling or unable to comply with study requirements",
                "criterions": [
                    {
                        "exact_snippets": "Subject has any kind of disorder that compromises the ability of the subject to give written informed consent",
                        "criterion": "disorder affecting consent ability",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Subject has any kind of disorder that compromises the ability of the subject ... to comply with study procedures",
                        "criterion": "disorder affecting compliance with study procedures",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Subject ... is unwilling or unable to comply with study requirements",
                        "criterion": "willingness or ability to comply with study requirements",
                        "requirement": {
                            "requirement_type": "willingness or ability",
                            "expected_value": true
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                    }
                ]
            },
            "logical_structure": {
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                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Subject has any kind of disorder that compromises the ability of the subject to give written informed consent",
                                        "criterion": "disorder affecting consent ability",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "Subject has any kind of disorder that compromises the ability of the subject ... to comply with study procedures",
                                        "criterion": "disorder affecting compliance with study procedures",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Subject ... is unwilling or unable to comply with study requirements",
                                        "criterion": "willingness or ability to comply with study requirements",
                                        "requirement": {
                                            "requirement_type": "willingness or ability",
                                            "expected_value": false
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                                    }
                                ]
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                        ]
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}