{
    "info": {
        "nct_id": "NCT02217020",
        "official_title": "A Phase II Study of Neoadjuvant FOLFOXIRI Chemotherapy Alone in Treating Patients With Locally Advanced Rectal Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "* Hypersensitivity to fluorouracil, oxaliplatin or irinotecan.\n* No More than 4 weeks since prior participation in any investigational drug study\n* More than 4 weeks since prior participation in any investigational drug study\n* Clear indication of involvement of the pelvic side walls by imaging\n* With distant metastasis\n* History of invasive rectal malignancy, regardless of disease-free interval\n* Fertile patients must use effective contraception\n* Uncontrolled hypertension\n* Cardiovascular disease that would preclude study treatment or follow-up\n* Lack of upper gastrointestinal tract integrity or malabsorption syndrome，active upper gastrointestinal tract bleeding\n* Synchronous colon cancer\n* Pregnant or nursing, Fertile patients do not use effective contraception\n* Other malignancy within the past 5 years except effectively treated squamous cell or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum\n* No psychiatric or addictive disorders, or other conditions that, in the opinion of the investigator, would preclude study participation\n* patients refused to signed informed consent.",
        "miscellaneous_criteria": "Inclusion Criteria\n\n* Diagnosis of adenocarcinoma of the rectum\n* Age: 18-70 years old\n* Signed informed consent; able to comply with study and/or follow- up procedures\n* Stage of the primary tumor may be determined by ultrasound or MRI\n* Stage II (T3-4, N0 [N0 is defined as all imaged lymph nodes < 1.0 cm]) OR stage III (T1-4, N1-2 [with the definition of a clinically positive lymph node being any node ≥ 1.0 cm]\n* Tumor palpable by digital rectal exam OR accessible by proctoscope or sigmoidoscope\n* Distal border of the tumor must be located < 12 cm from the anal verge\n* Tumor amenable to curative resection\n* Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:\n* Leukocytes ≥ 3.0 x109/ L, absolute neutrophil count (ANC) ≥ 1.5 x109/ L, platelet count ≥ 100 x109/ L, hemoglobin (Hb) ≥ 9g/ dL.\n* Total bilirubin ≤1.5 x the upper limit of normal (ULN).\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN.\n* Alkaline phosphatase limit ≤ 5x ULN.\n* Amylase and lipase ≤ 1.5 x the ULN.\n* Serum creatinine ≤ 1.5 x the ULN.\n* Calculated creatinine clearance or 24 hour creatinine clearance ≥ 50 mL/ min.\n* No renal disease that would preclude study treatment or follow-up\n* ECOG status: 0～1"
    },
    "inclusion_lines": [
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 70 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Hypersensitivity to fluorouracil, oxaliplatin or irinotecan.",
            "criterions": [
                {
                    "exact_snippets": "Hypersensitivity to fluorouracil",
                    "criterion": "hypersensitivity to fluorouracil",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Hypersensitivity to ... oxaliplatin",
                    "criterion": "hypersensitivity to oxaliplatin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Hypersensitivity to ... irinotecan",
                    "criterion": "hypersensitivity to irinotecan",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No More than 4 weeks since prior participation in any investigational drug study",
            "criterions": [
                {
                    "exact_snippets": "No More than 4 weeks since prior participation in any investigational drug study",
                    "criterion": "time since prior investigational drug study participation",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 4 weeks since prior participation in any investigational drug study",
            "criterions": [
                {
                    "exact_snippets": "More than 4 weeks since prior participation in any investigational drug study",
                    "criterion": "participation in investigational drug study",
                    "requirements": [
                        {
                            "requirement_type": "time since last participation",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clear indication of involvement of the pelvic side walls by imaging",
            "criterions": [
                {
                    "exact_snippets": "involvement of the pelvic side walls by imaging",
                    "criterion": "pelvic side wall involvement",
                    "requirements": [
                        {
                            "requirement_type": "detection method",
                            "expected_value": "imaging"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* With distant metastasis",
            "criterions": [
                {
                    "exact_snippets": "distant metastasis",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of invasive rectal malignancy, regardless of disease-free interval",
            "criterions": [
                {
                    "exact_snippets": "History of invasive rectal malignancy",
                    "criterion": "invasive rectal malignancy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fertile patients must use effective contraception",
            "criterions": [
                {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    ]
                },
                {
                    "exact_snippets": "must use effective contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled hypertension",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cardiovascular disease that would preclude study treatment or follow-up",
            "criterions": [
                {
                    "exact_snippets": "Cardiovascular disease that would preclude study treatment or follow-up",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "impact on study",
                            "expected_value": "preclude study treatment or follow-up"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lack of upper gastrointestinal tract integrity or malabsorption syndrome，active upper gastrointestinal tract bleeding",
            "criterions": [
                {
                    "exact_snippets": "Lack of upper gastrointestinal tract integrity",
                    "criterion": "upper gastrointestinal tract integrity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "malabsorption syndrome",
                    "criterion": "malabsorption syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active upper gastrointestinal tract bleeding",
                    "criterion": "upper gastrointestinal tract bleeding",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Synchronous colon cancer",
            "criterions": [
                {
                    "exact_snippets": "Synchronous colon cancer",
                    "criterion": "synchronous colon cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or nursing, Fertile patients do not use effective contraception",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "nursing",
                    "criterion": "nursing status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Fertile patients do not use effective contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other malignancy within the past 5 years except effectively treated squamous cell or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum",
            "criterions": [
                {
                    "exact_snippets": "Other malignancy within the past 5 years",
                    "criterion": "other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except effectively treated squamous cell or basal cell skin cancer",
                    "criterion": "effectively treated squamous cell or basal cell skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... melanoma in situ",
                    "criterion": "melanoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... carcinoma in situ of the cervix",
                    "criterion": "carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... carcinoma in situ of the colon or rectum",
                    "criterion": "carcinoma in situ of the colon or rectum",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No psychiatric or addictive disorders, or other conditions that, in the opinion of the investigator, would preclude study participation",
            "criterions": [
                {
                    "exact_snippets": "No psychiatric or addictive disorders",
                    "criterion": "psychiatric disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No psychiatric or addictive disorders",
                    "criterion": "addictive disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other conditions that, in the opinion of the investigator, would preclude study participation",
                    "criterion": "other conditions precluding participation",
                    "requirements": [
                        {
                            "requirement_type": "investigator's opinion",
                            "expected_value": "would preclude study participation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* patients refused to signed informed consent.",
            "criterions": [
                {
                    "exact_snippets": "patients refused to signed informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [
        {
            "line": "* Diagnosis of adenocarcinoma of the rectum",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of adenocarcinoma of the rectum",
                    "criterion": "adenocarcinoma of the rectum",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age: 18-70 years old",
            "criterions": [
                {
                    "exact_snippets": "Age: 18-70 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Signed informed consent; able to comply with study and/or follow- up procedures",
            "criterions": [
                {
                    "exact_snippets": "Signed informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "able to comply with study and/or follow- up procedures",
                    "criterion": "compliance with study procedures",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Stage of the primary tumor may be determined by ultrasound or MRI",
            "criterions": [
                {
                    "exact_snippets": "Stage of the primary tumor",
                    "criterion": "stage of the primary tumor",
                    "requirements": [
                        {
                            "requirement_type": "determination method",
                            "expected_value": [
                                "ultrasound",
                                "MRI"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Stage II (T3-4, N0 [N0 is defined as all imaged lymph nodes < 1.0 cm]) OR stage III (T1-4, N1-2 [with the definition of a clinically positive lymph node being any node ≥ 1.0 cm]",
            "criterions": [
                {
                    "exact_snippets": "Stage II (T3-4, N0 [N0 is defined as all imaged lymph nodes < 1.0 cm])",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "II"
                        },
                        {
                            "requirement_type": "tumor size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "T"
                            }
                        },
                        {
                            "requirement_type": "lymph node involvement",
                            "expected_value": "N0"
                        },
                        {
                            "requirement_type": "lymph node size",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.0,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "stage III (T1-4, N1-2 [with the definition of a clinically positive lymph node being any node ≥ 1.0 cm]",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "III"
                        },
                        {
                            "requirement_type": "tumor size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "T"
                            }
                        },
                        {
                            "requirement_type": "lymph node involvement",
                            "expected_value": [
                                "N1",
                                "N2"
                            ]
                        },
                        {
                            "requirement_type": "lymph node size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.0,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tumor palpable by digital rectal exam OR accessible by proctoscope or sigmoidoscope",
            "criterions": [
                {
                    "exact_snippets": "Tumor palpable by digital rectal exam",
                    "criterion": "tumor palpability",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "digital rectal exam"
                        }
                    ]
                },
                {
                    "exact_snippets": "Tumor ... accessible by proctoscope",
                    "criterion": "tumor accessibility",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "proctoscope"
                        }
                    ]
                },
                {
                    "exact_snippets": "Tumor ... accessible by ... sigmoidoscope",
                    "criterion": "tumor accessibility",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "sigmoidoscope"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Distal border of the tumor must be located < 12 cm from the anal verge",
            "criterions": [
                {
                    "exact_snippets": "Distal border of the tumor ... < 12 cm from the anal verge",
                    "criterion": "distal border of the tumor location",
                    "requirements": [
                        {
                            "requirement_type": "distance from anal verge",
                            "expected_value": {
                                "operator": "<",
                                "value": 12,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tumor amenable to curative resection",
            "criterions": [
                {
                    "exact_snippets": "Tumor amenable to curative resection",
                    "criterion": "tumor",
                    "requirements": [
                        {
                            "requirement_type": "amenability to curative resection",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Leukocytes ≥ 3.0 x109/ L, absolute neutrophil count (ANC) ≥ 1.5 x109/ L, platelet count ≥ 100 x109/ L, hemoglobin (Hb) ≥ 9g/ dL.",
            "criterions": [
                {
                    "exact_snippets": "Leukocytes ≥ 3.0 x109/ L",
                    "criterion": "leukocytes",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3.0,
                                "unit": "x10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "absolute neutrophil count (ANC) ≥ 1.5 x109/ L",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelet count ≥ 100 x109/ L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hemoglobin (Hb) ≥ 9g/ dL",
                    "criterion": "hemoglobin (Hb)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin ≤1.5 x the upper limit of normal (ULN).",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin ≤1.5 x the upper limit of normal (ULN).",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN.",
            "criterions": [
                {
                    "exact_snippets": "Alanine aminotransferase (ALT) ... ≤ 5 x ULN.",
                    "criterion": "Alanine aminotransferase (ALT) level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate aminotransferase (AST) ≤ 5 x ULN.",
                    "criterion": "Aspartate aminotransferase (AST) level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Alkaline phosphatase limit ≤ 5x ULN.",
            "criterions": [
                {
                    "exact_snippets": "Alkaline phosphatase limit ≤ 5x ULN.",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "limit",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Amylase and lipase ≤ 1.5 x the ULN.",
            "criterions": [
                {
                    "exact_snippets": "Amylase ... ≤ 1.5 x the ULN.",
                    "criterion": "amylase level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "lipase ≤ 1.5 x the ULN.",
                    "criterion": "lipase level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine ≤ 1.5 x the ULN.",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine ≤ 1.5 x the ULN.",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x the ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Calculated creatinine clearance or 24 hour creatinine clearance ≥ 50 mL/ min.",
            "criterions": [
                {
                    "exact_snippets": "Calculated creatinine clearance ... ≥ 50 mL/ min.",
                    "criterion": "calculated creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "24 hour creatinine clearance ≥ 50 mL/ min.",
                    "criterion": "24 hour creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No renal disease that would preclude study treatment or follow-up",
            "criterions": [
                {
                    "exact_snippets": "No renal disease that would preclude study treatment or follow-up",
                    "criterion": "renal disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG status: 0～1",
            "criterions": [
                {
                    "exact_snippets": "ECOG status: 0～1",
                    "criterion": "ECOG status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Inclusion Criteria",
            "criterions": []
        },
        {
            "line": "* Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:",
            "criterions": [
                {
                    "exact_snippets": "Adequate bone marrow",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "adequate"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... hepatic",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "adequate"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "adequate"
                        }
                    ]
                }
            ]
        }
    ]
}