{
    "info": {
        "nct_id": "NCT03531931",
        "official_title": "Single-arm Exploratory Clinical Study on the Second-line Treatment of Advanced Gastric Cancer With Apatinib Mesylate Plus Capecitabine",
        "inclusion_criteria": "* 1. Age：18~75 years; 2. Subjects with pathologically (included histologically or cytologically) confirmed gastric adenocarcinoma, unresectable local advanced or metastatic tumors; 3. Only second-line gastric cancer patients in late phase and at least one month interval from the latest chemotherapy treatment; 4. Previous treatment program without apatinib or capecitabine or any other antiangiogenic medications; 5. Subjects with at least one measurable lesion (defined by RECIST ,version 1.1), which is confirmed by computed tomography (CT) scan or MRI≥10mm .\n\n  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 7. Survival expectation≥ 3 months; 8. Subjects were recovered from damages caused by other treatments, with the interval ≥ 6 weeks for the treatment of the Nitro or Mitomycin, and 4 weeks for other cytotoxic drugs, radiotherapy or surgery, and the wound is completely healed 9. Subjects without severe heart, lung or liver dysfunction, no jaundice and digestive tract obstruction, and acute infection associated 10. The main organs function normally, and meet the following standards:\n  1. Standard of blood routine examination conforms to ( no blood transfusion within 14 days):\n\n     1. Hemoglobin (HB)≥ 80 g/L;\n     2. Leukocyte(WBC)≥3.5×109/L;\n     3. Absolute neutrophil count (ANC)≥1.5×109/L;\n\n     c. Platelet count (PLT) ≥75×109/L；\n  2. Sufficient liver function:\n\n     1. Bilirubin(BIL) <1.25×the upper limit of normal (ULN);\n     2. Alanine aminotransferase (ALT), and Aspartate aminotransferase (AST) <2.5×(ULN), Glutamic-pyruvic transaminase(GPT)≤1.5×ULN. If liver metastases occur, ALT and AST <5×(ULN), GPT≤3×(ULT);\n     3. Serum Creatinine(Cr) ≤1.0×（ULN）, or creatinine clearance > 50 mL/min( calculated per the Cockcroft and Gault formula); 11. Females of childbearing potential must receive a pregnancy test within 7 days before participating ( including serum), and the results are negative, and also willingly take appropriate methods for contraception during the trial or within 8 weeks after the latest medication. Males should be surgically sterilized or agreed to use the appropriate contraceptive method during the trial or within 8 weeks after the latest medication.\n\n        12. Subjects provided written informed consent before participating, willing and able to comply with all aspects of the protocol.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* 1. Pregnant or lactating females; 2. Subjects previously or meanwhile with other malignancies, except cured cutaneous basal cell carcinoma and cervical carcinoma; 3. Subjects with severe heart, liver, kidney disease; with uncontrolled symptomatic brain metastases; with neurological and psychiatric disorders; with severe infection; 4. With high blood pressure and treated with antihypertensive drugs still unable to reduce to the normal range (systolic pressure > 140 mmhg, diastolic pressure >90 mmhg ); 5. With level I above coronary heart disease, arrhythmia (including QTc period extended, male >450 ms, female >470 ms) and cardiac insufficiency; 6. with obvious gastrointestinal bleeding tendencies, include the following situation: locally active ulcer lesions, fecal occult blood (+ +), and within 2 months with a history of black stool or vomiting of blood; coagulation dysfunction (INR>1.5, APTT>1.5 ULN); 7. With Previous history of cardio-cerebral vascular disease, now still take oral thrombolytic drugs or anticoagulant drugs; 8. Urine protein examination confirmed positive (urine protein detection ++ or above, or 24-hour urine protein quantitative detection >1.0g); 9. According to the investigators' judgment, subjects who put other subjects at risk of the safety or disturb their clinical trial devolpment; 10. There are factors that affect oral administration (such as inability to swallow, persistent uncontrolled nausea, vomiting, chronic diarrhea, and intestinal obstruction); 11. Subjects confirmed unsuitable for the clinical trial by investigators.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* 1. Age：18~75 years; 2. Subjects with pathologically (included histologically or cytologically) confirmed gastric adenocarcinoma, unresectable local advanced or metastatic tumors; 3. Only second-line gastric cancer patients in late phase and at least one month interval from the latest chemotherapy treatment; 4. Previous treatment program without apatinib or capecitabine or any other antiangiogenic medications; 5. Subjects with at least one measurable lesion (defined by RECIST ,version 1.1), which is confirmed by computed tomography (CT) scan or MRI≥10mm .",
                "criterions": [
                    {
                        "exact_snippets": "Age：18~75 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Subjects with pathologically (included histologically or cytologically) confirmed gastric adenocarcinoma",
                        "criterion": "gastric adenocarcinoma",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "pathologically (included histologically or cytologically) confirmed"
                        }
                    },
                    {
                        "exact_snippets": "unresectable local advanced or metastatic tumors",
                        "criterion": "tumor resectability and stage",
                        "requirement": {
                            "requirement_type": "resectability",
                            "expected_value": "unresectable"
                        }
                    },
                    {
                        "exact_snippets": "unresectable local advanced or metastatic tumors",
                        "criterion": "tumor resectability and stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "local advanced",
                                "metastatic"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Only second-line gastric cancer patients in late phase",
                        "criterion": "treatment line and phase",
                        "requirement": {
                            "requirement_type": "treatment line",
                            "expected_value": "second-line"
                        }
                    },
                    {
                        "exact_snippets": "Only second-line gastric cancer patients in late phase",
                        "criterion": "treatment line and phase",
                        "requirement": {
                            "requirement_type": "phase",
                            "expected_value": "late phase"
                        }
                    },
                    {
                        "exact_snippets": "at least one month interval from the latest chemotherapy treatment",
                        "criterion": "interval from latest chemotherapy",
                        "requirement": {
                            "requirement_type": "interval",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Previous treatment program without apatinib or capecitabine or any other antiangiogenic medications",
                        "criterion": "previous treatment with specific medications",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": [
                                "apatinib",
                                "capecitabine",
                                "any other antiangiogenic medications"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Subjects with at least one measurable lesion (defined by RECIST ,version 1.1), which is confirmed by computed tomography (CT) scan or MRI≥10mm",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "confirmed by computed tomography (CT) scan or MRI"
                        }
                    },
                    {
                        "exact_snippets": "Subjects with at least one measurable lesion (defined by RECIST ,version 1.1), which is confirmed by computed tomography (CT) scan or MRI≥10mm",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Age：18~75 years",
                                "criterion": "age",
                                "requirement": {
                                    "requirement_type": "range",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": ">=",
                                                "value": 18,
                                                "unit": "years"
                                            },
                                            {
                                                "operator": "<=",
                                                "value": 75,
                                                "unit": "years"
                                            }
                                        ]
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Subjects with pathologically (included histologically or cytologically) confirmed gastric adenocarcinoma",
                                "criterion": "gastric adenocarcinoma",
                                "requirement": {
                                    "requirement_type": "confirmation",
                                    "expected_value": "pathologically (included histologically or cytologically) confirmed"
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "unresectable local advanced or metastatic tumors",
                                        "criterion": "tumor resectability and stage",
                                        "requirement": {
                                            "requirement_type": "resectability",
                                            "expected_value": "unresectable"
                                        }
                                    },
                                    {
                                        "exact_snippets": "unresectable local advanced or metastatic tumors",
                                        "criterion": "tumor resectability and stage",
                                        "requirement": {
                                            "requirement_type": "stage",
                                            "expected_value": [
                                                "local advanced",
                                                "metastatic"
                                            ]
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Only second-line gastric cancer patients in late phase",
                                        "criterion": "treatment line and phase",
                                        "requirement": {
                                            "requirement_type": "treatment line",
                                            "expected_value": "second-line"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Only second-line gastric cancer patients in late phase",
                                        "criterion": "treatment line and phase",
                                        "requirement": {
                                            "requirement_type": "phase",
                                            "expected_value": "late phase"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "at least one month interval from the latest chemotherapy treatment",
                                "criterion": "interval from latest chemotherapy",
                                "requirement": {
                                    "requirement_type": "interval",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "month"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Previous treatment program without apatinib or capecitabine or any other antiangiogenic medications",
                                "criterion": "previous treatment with specific medications",
                                "requirement": {
                                    "requirement_type": "absence",
                                    "expected_value": [
                                        "apatinib",
                                        "capecitabine",
                                        "any other antiangiogenic medications"
                                    ]
                                }
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Subjects with at least one measurable lesion (defined by RECIST ,version 1.1), which is confirmed by computed tomography (CT) scan or MRI≥10mm",
                                        "criterion": "measurable lesion",
                                        "requirement": {
                                            "requirement_type": "confirmation",
                                            "expected_value": "confirmed by computed tomography (CT) scan or MRI"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Subjects with at least one measurable lesion (defined by RECIST ,version 1.1), which is confirmed by computed tomography (CT) scan or MRI≥10mm",
                                        "criterion": "measurable lesion",
                                        "requirement": {
                                            "requirement_type": "size",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 10,
                                                "unit": "mm"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 7. Survival expectation≥ 3 months; 8. Subjects were recovered from damages caused by other treatments, with the interval ≥ 6 weeks for the treatment of the Nitro or Mitomycin, and 4 weeks for other cytotoxic drugs, radiotherapy or surgery, and the wound is completely healed 9. Subjects without severe heart, lung or liver dysfunction, no jaundice and digestive tract obstruction, and acute infection associated 10. The main organs function normally, and meet the following standards:",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0-2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Survival expectation≥ 3 months",
                        "criterion": "survival expectation",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Subjects were recovered from damages caused by other treatments",
                        "criterion": "recovery from treatment damages",
                        "requirement": {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "interval ≥ 6 weeks for the treatment of the Nitro or Mitomycin",
                        "criterion": "interval since Nitro or Mitomycin treatment",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "interval ... 4 weeks for other cytotoxic drugs, radiotherapy or surgery",
                        "criterion": "interval since other cytotoxic drugs, radiotherapy or surgery",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "the wound is completely healed",
                        "criterion": "wound healing",
                        "requirement": {
                            "requirement_type": "healing",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Subjects without severe heart, lung or liver dysfunction",
                        "criterion": "heart, lung, or liver dysfunction",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "not severe"
                        }
                    },
                    {
                        "exact_snippets": "no jaundice",
                        "criterion": "jaundice",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "no ... digestive tract obstruction",
                        "criterion": "digestive tract obstruction",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "no ... acute infection associated",
                        "criterion": "acute infection",
                        "requirement": {
                            "requirement_type": "association",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "and_criteria": [
                                                    {
                                                        "and_criteria": [
                                                            {
                                                                "and_criteria": [
                                                                    {
                                                                        "and_criteria": [
                                                                            {
                                                                                "and_criteria": [
                                                                                    {
                                                                                        "and_criteria": [
                                                                                            {
                                                                                                "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0-2",
                                                                                                "criterion": "ECOG performance status",
                                                                                                "requirement": {
                                                                                                    "requirement_type": "range",
                                                                                                    "expected_value": {
                                                                                                        "comparisons": [
                                                                                                            {
                                                                                                                "operator": ">=",
                                                                                                                "value": 0,
                                                                                                                "unit": "N/A"
                                                                                                            },
                                                                                                            {
                                                                                                                "operator": "<=",
                                                                                                                "value": 2,
                                                                                                                "unit": "N/A"
                                                                                                            }
                                                                                                        ]
                                                                                                    }
                                                                                                }
                                                                                            },
                                                                                            {
                                                                                                "exact_snippets": "Survival expectation≥ 3 months",
                                                                                                "criterion": "survival expectation",
                                                                                                "requirement": {
                                                                                                    "requirement_type": "duration",
                                                                                                    "expected_value": {
                                                                                                        "operator": ">=",
                                                                                                        "value": 3,
                                                                                                        "unit": "months"
                                                                                                    }
                                                                                                }
                                                                                            }
                                                                                        ]
                                                                                    },
                                                                                    {
                                                                                        "exact_snippets": "Subjects were recovered from damages caused by other treatments",
                                                                                        "criterion": "recovery from treatment damages",
                                                                                        "requirement": {
                                                                                            "requirement_type": "recovery",
                                                                                            "expected_value": true
                                                                                        }
                                                                                    }
                                                                                ]
                                                                            },
                                                                            {
                                                                                "or_criteria": [
                                                                                    {
                                                                                        "exact_snippets": "interval ≥ 6 weeks for the treatment of the Nitro or Mitomycin",
                                                                                        "criterion": "interval since Nitro or Mitomycin treatment",
                                                                                        "requirement": {
                                                                                            "requirement_type": "duration",
                                                                                            "expected_value": {
                                                                                                "operator": ">=",
                                                                                                "value": 6,
                                                                                                "unit": "weeks"
                                                                                            }
                                                                                        }
                                                                                    },
                                                                                    {
                                                                                        "exact_snippets": "interval ... 4 weeks for other cytotoxic drugs, radiotherapy or surgery",
                                                                                        "criterion": "interval since other cytotoxic drugs, radiotherapy or surgery",
                                                                                        "requirement": {
                                                                                            "requirement_type": "duration",
                                                                                            "expected_value": {
                                                                                                "operator": ">=",
                                                                                                "value": 4,
                                                                                                "unit": "weeks"
                                                                                            }
                                                                                        }
                                                                                    }
                                                                                ]
                                                                            }
                                                                        ]
                                                                    },
                                                                    {
                                                                        "exact_snippets": "the wound is completely healed",
                                                                        "criterion": "wound healing",
                                                                        "requirement": {
                                                                            "requirement_type": "healing",
                                                                            "expected_value": true
                                                                        }
                                                                    }
                                                                ]
                                                            },
                                                            {
                                                                "exact_snippets": "Subjects without severe heart, lung or liver dysfunction",
                                                                "criterion": "heart, lung, or liver dysfunction",
                                                                "requirement": {
                                                                    "requirement_type": "severity",
                                                                    "expected_value": "not severe"
                                                                }
                                                            }
                                                        ]
                                                    },
                                                    {
                                                        "exact_snippets": "no jaundice",
                                                        "criterion": "jaundice",
                                                        "requirement": {
                                                            "requirement_type": "presence",
                                                            "expected_value": false
                                                        }
                                                    }
                                                ]
                                            },
                                            {
                                                "exact_snippets": "no ... digestive tract obstruction",
                                                "criterion": "digestive tract obstruction",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": false
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "no ... acute infection associated",
                                        "criterion": "acute infection",
                                        "requirement": {
                                            "requirement_type": "association",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "The main organs function normally, and meet the following standards:",
                                "criterion": "main organ function",
                                "requirement": {
                                    "requirement_type": "functionality",
                                    "expected_value": "normal"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "The main organs function normally, and meet the following standards:",
                        "criterion": "main organ function standards",
                        "requirement": {
                            "requirement_type": "standards",
                            "expected_value": "met"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. 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": "c. Platelet count (PLT) ≥75×109/L；",
                "criterions": [
                    {
                        "exact_snippets": "Platelet count (PLT) ≥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 (PLT) ≥75×109/L",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 75,
                                "unit": "×10^9/L"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Sufficient liver function:",
                "criterions": [
                    {
                        "exact_snippets": "Sufficient liver function",
                        "criterion": "liver function",
                        "requirement": {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Sufficient liver function",
                        "criterion": "liver function",
                        "requirement": {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. Bilirubin(BIL) <1.25×the upper limit of normal (ULN);",
                "criterions": [
                    {
                        "exact_snippets": "Bilirubin(BIL) <1.25×the upper limit of normal (ULN)",
                        "criterion": "bilirubin level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.25,
                                "unit": "× ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Bilirubin(BIL) <1.25×the upper limit of normal (ULN)",
                        "criterion": "bilirubin level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.25,
                                "unit": "× ULN"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Serum Creatinine(Cr) ≤1.0×（ULN）, or creatinine clearance > 50 mL/min( calculated per the Cockcroft and Gault formula); 11. Females of childbearing potential must receive a pregnancy test within 7 days before participating ( including serum), and the results are negative, and also willingly take appropriate methods for contraception during the trial or within 8 weeks after the latest medication. Males should be surgically sterilized or agreed to use the appropriate contraceptive method during the trial or within 8 weeks after the latest medication.",
                "criterions": [
                    {
                        "exact_snippets": "Serum Creatinine(Cr) ≤1.0×（ULN）",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.0,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "creatinine clearance > 50 mL/min",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Females of childbearing potential must receive a pregnancy test within 7 days before participating ... results are negative",
                        "criterion": "pregnancy test",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days before participating"
                        }
                    },
                    {
                        "exact_snippets": "Females of childbearing potential must receive a pregnancy test within 7 days before participating ... results are negative",
                        "criterion": "pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "Females of childbearing potential ... willingly take appropriate methods for contraception during the trial or within 8 weeks after the latest medication",
                        "criterion": "contraception for females",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "during the trial or within 8 weeks after the latest medication"
                        }
                    },
                    {
                        "exact_snippets": "Males should be surgically sterilized or agreed to use the appropriate contraceptive method during the trial or within 8 weeks after the latest medication",
                        "criterion": "contraception for males",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": [
                                "surgically sterilized",
                                "appropriate contraceptive method"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Males should be surgically sterilized or agreed to use the appropriate contraceptive method during the trial or within 8 weeks after the latest medication",
                        "criterion": "contraception for males",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "during the trial or within 8 weeks after the latest medication"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Serum Creatinine(Cr) ≤1.0×（ULN）",
                                "criterion": "serum creatinine",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1.0,
                                        "unit": "ULN"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "creatinine clearance > 50 mL/min",
                                "criterion": "creatinine clearance",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 50,
                                        "unit": "mL/min"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Females of childbearing potential must receive a pregnancy test within 7 days before participating ... results are negative",
                                        "criterion": "pregnancy test",
                                        "requirement": {
                                            "requirement_type": "timing",
                                            "expected_value": "within 7 days before participating"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Females of childbearing potential must receive a pregnancy test within 7 days before participating ... results are negative",
                                        "criterion": "pregnancy test",
                                        "requirement": {
                                            "requirement_type": "result",
                                            "expected_value": "negative"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Females of childbearing potential ... willingly take appropriate methods for contraception during the trial or within 8 weeks after the latest medication",
                                        "criterion": "contraception for females",
                                        "requirement": {
                                            "requirement_type": "duration",
                                            "expected_value": "during the trial or within 8 weeks after the latest medication"
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Males should be surgically sterilized or agreed to use the appropriate contraceptive method during the trial or within 8 weeks after the latest medication",
                                        "criterion": "contraception for males",
                                        "requirement": {
                                            "requirement_type": "method",
                                            "expected_value": [
                                                "surgically sterilized",
                                                "appropriate contraceptive method"
                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "Males should be surgically sterilized or agreed to use the appropriate contraceptive method during the trial or within 8 weeks after the latest medication",
                                        "criterion": "contraception for males",
                                        "requirement": {
                                            "requirement_type": "duration",
                                            "expected_value": "during the trial or within 8 weeks after the latest medication"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "12. Subjects provided written informed consent before participating, willing and able to comply with all aspects of the protocol.",
                "criterions": [
                    {
                        "exact_snippets": "Subjects provided written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willing and able to comply with all aspects of the protocol",
                        "criterion": "compliance with protocol",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willing and able to comply with all aspects of the protocol",
                        "criterion": "compliance with protocol",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Subjects provided written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "willing and able to comply with all aspects of the protocol",
                                "criterion": "compliance with protocol",
                                "requirement": {
                                    "requirement_type": "willingness",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "willing and able to comply with all aspects of the protocol",
                                "criterion": "compliance with protocol",
                                "requirement": {
                                    "requirement_type": "ability",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 75 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 75 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 75 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "1. Standard of blood routine examination conforms to ( no blood transfusion within 14 days):",
                "criterions": [
                    {
                        "exact_snippets": "Standard of blood routine examination",
                        "criterion": "blood routine examination",
                        "requirement": {
                            "requirement_type": "standard",
                            "expected_value": "conforms"
                        }
                    },
                    {
                        "exact_snippets": "no blood transfusion within 14 days",
                        "criterion": "blood transfusion",
                        "requirement": {
                            "requirement_type": "time since last transfusion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "1. Hemoglobin (HB)≥ 80 g/L;",
                "criterions": [
                    {
                        "exact_snippets": "Hemoglobin (HB)≥ 80 g/L",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 80,
                                "unit": "g/L"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "2. Leukocyte(WBC)≥3.5×109/L;",
                "criterions": [
                    {
                        "exact_snippets": "Leukocyte(WBC)≥3.5×109/L",
                        "criterion": "leukocyte count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3.5,
                                "unit": "×10^9/L"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "2. Alanine aminotransferase (ALT), and Aspartate aminotransferase (AST) <2.5×(ULN), Glutamic-pyruvic transaminase(GPT)≤1.5×ULN. If liver metastases occur, ALT and AST <5×(ULN), GPT≤3×(ULT);",
                "criterions": [
                    {
                        "exact_snippets": "Alanine aminotransferase (ALT) ... <2.5×(ULN) ... If liver metastases occur, ALT ... <5×(ULN)",
                        "criterion": "Alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 2.5,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Alanine aminotransferase (ALT) ... <2.5×(ULN) ... If liver metastases occur, ALT ... <5×(ULN)",
                        "criterion": "Alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "level with liver metastases",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 5,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Aspartate aminotransferase (AST) <2.5×(ULN) ... If liver metastases occur, ... AST <5×(ULN)",
                        "criterion": "Aspartate aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 2.5,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Aspartate aminotransferase (AST) <2.5×(ULN) ... If liver metastases occur, ... AST <5×(ULN)",
                        "criterion": "Aspartate aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "level with liver metastases",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 5,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Glutamic-pyruvic transaminase(GPT)≤1.5×ULN ... If liver metastases occur, ... GPT≤3×(ULT)",
                        "criterion": "Glutamic-pyruvic transaminase (GPT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Glutamic-pyruvic transaminase(GPT)≤1.5×ULN ... If liver metastases occur, ... GPT≤3×(ULT)",
                        "criterion": "Glutamic-pyruvic transaminase (GPT)",
                        "requirement": {
                            "requirement_type": "level with liver metastases",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "ULT"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "If liver metastases occur",
                    "criterion": "liver metastases",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "Alanine aminotransferase (ALT) ... If liver metastases occur, ALT ... <5×(ULN)",
                            "criterion": "Alanine aminotransferase (ALT)",
                            "requirement": {
                                "requirement_type": "level with liver metastases",
                                "expected_value": {
                                    "comparisons": [
                                        {
                                            "operator": "<",
                                            "value": 5,
                                            "unit": "ULN"
                                        }
                                    ]
                                }
                            }
                        },
                        {
                            "exact_snippets": "Aspartate aminotransferase (AST) ... If liver metastases occur, ... AST <5×(ULN)",
                            "criterion": "Aspartate aminotransferase (AST)",
                            "requirement": {
                                "requirement_type": "level with liver metastases",
                                "expected_value": {
                                    "comparisons": [
                                        {
                                            "operator": "<",
                                            "value": 5,
                                            "unit": "ULN"
                                        }
                                    ]
                                }
                            }
                        },
                        {
                            "exact_snippets": "Glutamic-pyruvic transaminase(GPT) ... If liver metastases occur, ... GPT≤3×(ULT)",
                            "criterion": "Glutamic-pyruvic transaminase (GPT)",
                            "requirement": {
                                "requirement_type": "level with liver metastases",
                                "expected_value": {
                                    "comparisons": [
                                        {
                                            "operator": "<=",
                                            "value": 3,
                                            "unit": "ULT"
                                        }
                                    ]
                                }
                            }
                        }
                    ]
                },
                "else_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "Alanine aminotransferase (ALT) ... <2.5×(ULN)",
                            "criterion": "Alanine aminotransferase (ALT)",
                            "requirement": {
                                "requirement_type": "level",
                                "expected_value": {
                                    "comparisons": [
                                        {
                                            "operator": "<",
                                            "value": 2.5,
                                            "unit": "ULN"
                                        }
                                    ]
                                }
                            }
                        },
                        {
                            "exact_snippets": "Aspartate aminotransferase (AST) <2.5×(ULN)",
                            "criterion": "Aspartate aminotransferase (AST)",
                            "requirement": {
                                "requirement_type": "level",
                                "expected_value": {
                                    "comparisons": [
                                        {
                                            "operator": "<",
                                            "value": 2.5,
                                            "unit": "ULN"
                                        }
                                    ]
                                }
                            }
                        },
                        {
                            "exact_snippets": "Glutamic-pyruvic transaminase(GPT)≤1.5×ULN",
                            "criterion": "Glutamic-pyruvic transaminase (GPT)",
                            "requirement": {
                                "requirement_type": "level",
                                "expected_value": {
                                    "comparisons": [
                                        {
                                            "operator": "<=",
                                            "value": 1.5,
                                            "unit": "ULN"
                                        }
                                    ]
                                }
                            }
                        }
                    ]
                }
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* 1. Pregnant or lactating females; 2. Subjects previously or meanwhile with other malignancies, except cured cutaneous basal cell carcinoma and cervical carcinoma; 3. Subjects with severe heart, liver, kidney disease; with uncontrolled symptomatic brain metastases; with neurological and psychiatric disorders; with severe infection; 4. With high blood pressure and treated with antihypertensive drugs still unable to reduce to the normal range (systolic pressure > 140 mmhg, diastolic pressure >90 mmhg ); 5. With level I above coronary heart disease, arrhythmia (including QTc period extended, male >450 ms, female >470 ms) and cardiac insufficiency; 6. with obvious gastrointestinal bleeding tendencies, include the following situation: locally active ulcer lesions, fecal occult blood (+ +), and within 2 months with a history of black stool or vomiting of blood; coagulation dysfunction (INR>1.5, APTT>1.5 ULN); 7. With Previous history of cardio-cerebral vascular disease, now still take oral thrombolytic drugs or anticoagulant drugs; 8. Urine protein examination confirmed positive (urine protein detection ++ or above, or 24-hour urine protein quantitative detection >1.0g); 9. According to the investigators' judgment, subjects who put other subjects at risk of the safety or disturb their clinical trial devolpment; 10. There are factors that affect oral administration (such as inability to swallow, persistent uncontrolled nausea, vomiting, chronic diarrhea, and intestinal obstruction); 11. Subjects confirmed unsuitable for the clinical trial by investigators.",
                "criterions": [
                    {
                        "exact_snippets": "Pregnant or lactating females",
                        "criterion": "pregnancy or lactation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Subjects previously or meanwhile with other malignancies",
                        "criterion": "other malignancies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "except cured cutaneous basal cell carcinoma and cervical carcinoma",
                        "criterion": "cured cutaneous basal cell carcinoma and cervical carcinoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Subjects with severe heart, liver, kidney disease",
                        "criterion": "severe heart, liver, kidney disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "with uncontrolled symptomatic brain metastases",
                        "criterion": "uncontrolled symptomatic brain metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "with neurological and psychiatric disorders",
                        "criterion": "neurological and psychiatric disorders",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "with severe infection",
                        "criterion": "severe infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "With high blood pressure and treated with antihypertensive drugs still unable to reduce to the normal range",
                        "criterion": "high blood pressure",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "systolic pressure > 140 mmhg, diastolic pressure >90 mmhg",
                        "criterion": "blood pressure",
                        "requirement": {
                            "requirement_type": "systolic pressure",
                            "expected_value": {
                                "operator": ">",
                                "value": 140,
                                "unit": "mmhg"
                            }
                        }
                    },
                    {
                        "exact_snippets": "systolic pressure > 140 mmhg, diastolic pressure >90 mmhg",
                        "criterion": "blood pressure",
                        "requirement": {
                            "requirement_type": "diastolic pressure",
                            "expected_value": {
                                "operator": ">",
                                "value": 90,
                                "unit": "mmhg"
                            }
                        }
                    },
                    {
                        "exact_snippets": "With level I above coronary heart disease, arrhythmia",
                        "criterion": "coronary heart disease, arrhythmia",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "level I above"
                        }
                    },
                    {
                        "exact_snippets": "including QTc period extended, male >450 ms, female >470 ms",
                        "criterion": "QTc period",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 450,
                                "unit": "ms"
                            }
                        }
                    },
                    {
                        "exact_snippets": "including QTc period extended, male >450 ms, female >470 ms",
                        "criterion": "QTc period",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 470,
                                "unit": "ms"
                            }
                        }
                    },
                    {
                        "exact_snippets": "cardiac insufficiency",
                        "criterion": "cardiac insufficiency",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "with obvious gastrointestinal bleeding tendencies",
                        "criterion": "gastrointestinal bleeding tendencies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "locally active ulcer lesions",
                        "criterion": "locally active ulcer lesions",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "fecal occult blood (+ +)",
                        "criterion": "fecal occult blood",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "++"
                        }
                    },
                    {
                        "exact_snippets": "within 2 months with a history of black stool or vomiting of blood",
                        "criterion": "history of black stool or vomiting of blood",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 2 months"
                        }
                    },
                    {
                        "exact_snippets": "coagulation dysfunction (INR>1.5, APTT>1.5 ULN)",
                        "criterion": "coagulation dysfunction",
                        "requirement": {
                            "requirement_type": "INR",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "coagulation dysfunction (INR>1.5, APTT>1.5 ULN)",
                        "criterion": "coagulation dysfunction",
                        "requirement": {
                            "requirement_type": "APTT",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Previous history of cardio-cerebral vascular disease, now still take oral thrombolytic drugs or anticoagulant drugs",
                        "criterion": "cardio-cerebral vascular disease",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Previous history of cardio-cerebral vascular disease, now still take oral thrombolytic drugs or anticoagulant drugs",
                        "criterion": "cardio-cerebral vascular disease",
                        "requirement": {
                            "requirement_type": "medication",
                            "expected_value": [
                                "oral thrombolytic drugs",
                                "anticoagulant drugs"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Urine protein examination confirmed positive (urine protein detection ++ or above, or 24-hour urine protein quantitative detection >1.0g)",
                        "criterion": "urine protein",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "++ or above"
                        }
                    },
                    {
                        "exact_snippets": "Urine protein examination confirmed positive (urine protein detection ++ or above, or 24-hour urine protein quantitative detection >1.0g)",
                        "criterion": "urine protein",
                        "requirement": {
                            "requirement_type": "24-hour urine protein quantitative detection",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.0,
                                "unit": "g"
                            }
                        }
                    },
                    {
                        "exact_snippets": "According to the investigators' judgment, subjects who put other subjects at risk of the safety or disturb their clinical trial devolpment",
                        "criterion": "risk to safety or disturbance to clinical trial",
                        "requirement": {
                            "requirement_type": "investigator judgment",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "factors that affect oral administration (such as inability to swallow, persistent uncontrolled nausea, vomiting, chronic diarrhea, and intestinal obstruction)",
                        "criterion": "factors affecting oral administration",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Subjects confirmed unsuitable for the clinical trial by investigators",
                        "criterion": "suitability for clinical trial",
                        "requirement": {
                            "requirement_type": "investigator confirmation",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_miscellaneous": []
}