{
    "info": {
        "nct_id": "NCT01271582",
        "official_title": "Investigation of Association Between UGT1A1 Polymorphisms and Irinotecan Toxicity in Korean Patients With Advanced Colorectal or Gastric Cancer Treated With FOLFIRI Regimen",
        "inclusion_criteria": "Subjects should meet all of the following criteria to participate in the trial.\n\n* Histologically confirmed colorectal or gastric cancer patients who are chemonaive or failed to 1st line chemotherapy\n* Subjects who are expected to receive toxicity test at least once after FOLFIRI treatment.\n* Aged 18 years or older.\n* ECOG performance status of ≤ 2.\n* Anticipated life expectancy of ≥ 3 months.\n* Clinically acceptable function of bone marrow, kidney and liver function as below.\n\n  1. ANC ≥ 1500/mm3 and platelet count ≥ 100,000/mm3\n  2. Serum total bilirubin ≤ 1.5 x ULN, alkaline phosphatase ≤ 2.5 x ULN, Serum ALT and AST ≤ 2.5 x ULN (Serum ALT and AST ≤ 5 x ULN, if liver metastases are present)\n  3. Serum creatinine ≤ 1.5 mg/dL or CLcr > 60 ml/min\n* Subjects whose written informed consent can be obtained prior to their participation in the trial.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "Subjects who meet any of the following criteria should not be included in the trial.\n\n* Pregnant or breast feeding women\n* Serious concurrent complication, severe active infection.\n* Subjects with chronic diarrhea, paralytic ileums, pulmonary fibrosis or pneumonia interstitialis\n* Subjects with epilepsia or severe psychiatric disorders.\n* Subjects who are regarded to be unsuitable for this trial by the investigator.\n* Subjects who are participating in other clinical trials\n* Subjects who have received prior chemotherapy including irinotecan.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Histologically confirmed colorectal or gastric cancer patients who are chemonaive or failed to 1st line chemotherapy",
                "criterions": [
                    {
                        "exact_snippets": "Histologically confirmed colorectal or gastric cancer",
                        "criterion": "cancer type",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "colorectal",
                                "gastric"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "chemonaive",
                        "criterion": "chemotherapy status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "chemonaive"
                        }
                    },
                    {
                        "exact_snippets": "failed to 1st line chemotherapy",
                        "criterion": "chemotherapy status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "failed to 1st line chemotherapy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Histologically confirmed colorectal or gastric cancer",
                                "criterion": "cancer type",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": [
                                        "colorectal",
                                        "gastric"
                                    ]
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "chemonaive",
                                        "criterion": "chemotherapy status",
                                        "requirement": {
                                            "requirement_type": "status",
                                            "expected_value": "chemonaive"
                                        }
                                    },
                                    {
                                        "exact_snippets": "failed to 1st line chemotherapy",
                                        "criterion": "chemotherapy status",
                                        "requirement": {
                                            "requirement_type": "status",
                                            "expected_value": "failed to 1st line chemotherapy"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Subjects who are expected to receive toxicity test at least once after FOLFIRI treatment.",
                "criterions": [
                    {
                        "exact_snippets": "expected to receive toxicity test",
                        "criterion": "toxicity test",
                        "requirement": {
                            "requirement_type": "frequency",
                            "expected_value": "at least once"
                        }
                    },
                    {
                        "exact_snippets": "after FOLFIRI treatment",
                        "criterion": "FOLFIRI treatment",
                        "requirement": {
                            "requirement_type": "sequence",
                            "expected_value": "before toxicity test"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "expected to receive toxicity test",
                        "criterion": "toxicity test",
                        "requirement": {
                            "requirement_type": "frequency",
                            "expected_value": "at least once"
                        }
                    },
                    {
                        "exact_snippets": "after FOLFIRI treatment",
                        "criterion": "FOLFIRI treatment",
                        "requirement": {
                            "requirement_type": "sequence",
                            "expected_value": "before toxicity test"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Aged 18 years or older.",
                "criterions": [
                    {
                        "exact_snippets": "Aged 18 years or older",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Aged 18 years or older",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* ECOG performance status of ≤ 2.",
                "criterions": [
                    {
                        "exact_snippets": "ECOG performance status of ≤ 2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ECOG performance status of ≤ 2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Anticipated life expectancy of ≥ 3 months.",
                "criterions": [
                    {
                        "exact_snippets": "Anticipated life expectancy of ≥ 3 months.",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Anticipated life expectancy of ≥ 3 months.",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Clinically acceptable function of bone marrow, kidney and liver function as below.",
                "criterions": [
                    {
                        "exact_snippets": "Clinically acceptable function of bone marrow",
                        "criterion": "bone marrow function",
                        "requirement": {
                            "requirement_type": "functionality",
                            "expected_value": "clinically acceptable"
                        }
                    },
                    {
                        "exact_snippets": "Clinically acceptable ... kidney",
                        "criterion": "kidney function",
                        "requirement": {
                            "requirement_type": "functionality",
                            "expected_value": "clinically acceptable"
                        }
                    },
                    {
                        "exact_snippets": "Clinically acceptable ... liver function",
                        "criterion": "liver function",
                        "requirement": {
                            "requirement_type": "functionality",
                            "expected_value": "clinically acceptable"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Clinically acceptable function of bone marrow",
                        "criterion": "bone marrow function",
                        "requirement": {
                            "requirement_type": "functionality",
                            "expected_value": "clinically acceptable"
                        }
                    },
                    {
                        "exact_snippets": "Clinically acceptable ... kidney",
                        "criterion": "kidney function",
                        "requirement": {
                            "requirement_type": "functionality",
                            "expected_value": "clinically acceptable"
                        }
                    },
                    {
                        "exact_snippets": "Clinically acceptable ... liver function",
                        "criterion": "liver function",
                        "requirement": {
                            "requirement_type": "functionality",
                            "expected_value": "clinically acceptable"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. ANC ≥ 1500/mm3 and platelet count ≥ 100,000/mm3",
                "criterions": [
                    {
                        "exact_snippets": "ANC ≥ 1500/mm3",
                        "criterion": "ANC",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm3"
                            }
                        }
                    },
                    {
                        "exact_snippets": "platelet count ≥ 100,000/mm3",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ANC ≥ 1500/mm3",
                        "criterion": "ANC",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm3"
                            }
                        }
                    },
                    {
                        "exact_snippets": "platelet count ≥ 100,000/mm3",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Subjects whose written informed consent can be obtained prior to their participation in the trial.",
                "criterions": [
                    {
                        "exact_snippets": "written informed consent can be obtained",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "obtainability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "written informed consent can be obtained",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "obtainability",
                            "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": "Subjects should meet all of the following criteria to participate in the trial.",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "Subjects who meet any of the following criteria should not be included in the trial.",
                "criterions": [
                    {
                        "exact_snippets": "Subjects who meet any of the following criteria should not be included in the trial.",
                        "criterion": "eligibility for trial inclusion",
                        "requirement": {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Subjects who meet any of the following criteria should not be included in the trial.",
                        "criterion": "eligibility for trial inclusion",
                        "requirement": {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Pregnant or breast feeding women",
                "criterions": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breast feeding",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breast feeding",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Serious concurrent complication, severe active infection.",
                "criterions": [
                    {
                        "exact_snippets": "Serious concurrent complication",
                        "criterion": "concurrent complication",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    },
                    {
                        "exact_snippets": "severe active infection",
                        "criterion": "active infection",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Serious concurrent complication",
                        "criterion": "concurrent complication",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    },
                    {
                        "exact_snippets": "severe active infection",
                        "criterion": "active infection",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Subjects with chronic diarrhea, paralytic ileums, pulmonary fibrosis or pneumonia interstitialis",
                "criterions": [
                    {
                        "exact_snippets": "chronic diarrhea",
                        "criterion": "chronic diarrhea",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "paralytic ileums",
                        "criterion": "paralytic ileums",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "pulmonary fibrosis",
                        "criterion": "pulmonary fibrosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "pneumonia interstitialis",
                        "criterion": "pneumonia interstitialis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "chronic diarrhea",
                        "criterion": "chronic diarrhea",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "paralytic ileums",
                        "criterion": "paralytic ileums",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "pulmonary fibrosis",
                        "criterion": "pulmonary fibrosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "pneumonia interstitialis",
                        "criterion": "pneumonia interstitialis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Subjects with epilepsia or severe psychiatric disorders.",
                "criterions": [
                    {
                        "exact_snippets": "epilepsia",
                        "criterion": "epilepsia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "severe psychiatric disorders",
                        "criterion": "psychiatric disorders",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "severe psychiatric disorders",
                        "criterion": "psychiatric disorders",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "epilepsia",
                                "criterion": "epilepsia",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "severe psychiatric disorders",
                                "criterion": "psychiatric disorders",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "severe"
                                }
                            },
                            {
                                "exact_snippets": "severe psychiatric disorders",
                                "criterion": "psychiatric disorders",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Subjects who are regarded to be unsuitable for this trial by the investigator.",
                "criterions": [
                    {
                        "exact_snippets": "Subjects who are regarded to be unsuitable for this trial by the investigator.",
                        "criterion": "suitability for trial",
                        "requirement": {
                            "requirement_type": "determination",
                            "expected_value": "suitable"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Subjects who are regarded to be unsuitable for this trial by the investigator.",
                    "criterion": "suitability for trial",
                    "requirement": {
                        "requirement_type": "determination",
                        "expected_value": "suitable"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Subjects who are participating in other clinical trials",
                "criterions": [
                    {
                        "exact_snippets": "Subjects who are participating in other clinical trials",
                        "criterion": "participation in other clinical trials",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Subjects who are participating in other clinical trials",
                    "criterion": "participation in other clinical trials",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Subjects who have received prior chemotherapy including irinotecan.",
                "criterions": [
                    {
                        "exact_snippets": "Subjects who have received prior chemotherapy",
                        "criterion": "prior chemotherapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "including irinotecan",
                        "criterion": "irinotecan",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Subjects who have received prior chemotherapy",
                                "criterion": "prior chemotherapy",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "including irinotecan",
                                "criterion": "irinotecan",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "2. Serum total bilirubin ≤ 1.5 x ULN, alkaline phosphatase ≤ 2.5 x ULN, Serum ALT and AST ≤ 2.5 x ULN (Serum ALT and AST ≤ 5 x ULN, if liver metastases are present)",
                "criterions": [
                    {
                        "exact_snippets": "Serum total bilirubin ≤ 1.5 x ULN",
                        "criterion": "serum total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "alkaline phosphatase ≤ 2.5 x ULN",
                        "criterion": "alkaline phosphatase",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Serum ALT and AST ≤ 2.5 x ULN",
                        "criterion": "serum ALT and AST",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Serum ALT and AST ≤ 5 x ULN, if liver metastases are present",
                        "criterion": "serum ALT and AST with liver metastases",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Serum total bilirubin \u0010.5 x ULN",
                        "criterion": "serum total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "alkaline phosphatase \u0010.5 x ULN",
                        "criterion": "alkaline phosphatase",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "condition": {
                            "exact_snippets": "liver metastases are present",
                            "criterion": "liver metastases",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        },
                        "then_criteria": {
                            "exact_snippets": "Serum ALT and AST \u0015 x ULN, if liver metastases are present",
                            "criterion": "serum ALT and AST with liver metastases",
                            "requirement": {
                                "requirement_type": "level",
                                "expected_value": {
                                    "operator": "<=",
                                    "value": 5,
                                    "unit": "x ULN"
                                }
                            }
                        },
                        "else_criteria": {
                            "exact_snippets": "Serum ALT and AST \u0010.5 x ULN",
                            "criterion": "serum ALT and AST",
                            "requirement": {
                                "requirement_type": "level",
                                "expected_value": {
                                    "operator": "<=",
                                    "value": 2.5,
                                    "unit": "x ULN"
                                }
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Serum creatinine ≤ 1.5 mg/dL or CLcr > 60 ml/min",
                "criterions": [
                    {
                        "exact_snippets": "Serum creatinine ≤ 1.5 mg/dL",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "CLcr > 60 ml/min",
                        "criterion": "creatinine clearance (CLcr)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "ml/min"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Serum creatinine \u0010.5 mg/dL",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "CLcr > 60 ml/min",
                        "criterion": "creatinine clearance (CLcr)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "ml/min"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}