{
    "info": {
        "nct_id": "NCT03531320",
        "official_title": "Open-Label, Multicenter Study of D07001-Softgel Capsules (Oral Gemcitabine Hydrochloride) in Subjects With Unresectable, Metastatic or Locally Advanced Gastrointestinal (GI) Cancer in Dose-Escalation Phase and in Subjects With Advanced Biliary Tract Cancer (BTC) Following Primary Chemotherapy or Combined Chemoradiotherapy (CCRT) in Dose-Expansion Phase",
        "inclusion_criteria": "1. Provision of a signed and dated written Informed Consent Form (ICF) prior to any study specific procedures\n2. Male or female patients aged 18 years or older at screening (aged 20 years or older in Taiwan)\n3. Histopathological or cytologic diagnosis of unresectable, metastatic or locally advanced GI cancer (Part 1) or unresectable metastatic or locally advanced BTC (cholangiocarcinoma or gallbladder cancer; Part 2)\n4. Part 1 only: Refractory to or have relapsed from all standard therapies of advanced GI malignancy\n5. Part 2 only:\n\n   1. Achieved stable disease or better, based on the Investigator's assessment, in response to first line systemic therapy or CCRT, with continued stable disease or better based on imaging studies obtained as part of screening\n   2. Completed first line systemic therapy (with 2-8 cycles of chemotherapy with a gemcitabine based regimen) or CCRT, based on the local standard of care and preferences in the participating countries Note: No more than 30% of patients enrolled in Part 2 will have received CCRT\n6. No more than 60 days have elapsed between completion of the prior line of chemotherapy or CCRT and enrollment\n7. Part 2 only: Patient has not received intervening systemic therapy since first line treatment\n8. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2 in Part 1 and 0-1 in Part 2\n9. Life expectancy is >12 weeks\n10. Adequate bone marrow function, demonstrated by:\n\n    1. Absolute neutrophil count (ANC) ≥1,500 cell/mm3\n    2. Platelet count ≥100,000 cells/mm3\n    3. Hemoglobin ≥9 g/dL\n11. Adequate liver function, demonstrated by:\n\n    1. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 x upper limit of normal (ULN), or ≤5.0 x ULN in the case of liver metastases\n    2. Total bilirubin ≤1.5 x ULN\n    3. Albumin ≥3.0 g/dL\n    4. International normalized ratio (INR) <1.5\n12. Adequate renal function, demonstrated by:\n\n    1. Serum creatinine ≤1.5 x ULN\n    2. Creatinine clearance ≥ 60 mL/min calculated by Cockcroft-Gault formula or directly measured with 24 hr urine collection\n13. If a woman of childbearing potential, the patient has a negative serum pregnancy test at screening and is not breastfeeding\n14. If a woman of childbearing potential, patient must use a medically acceptable form of contraception as 2 barrier methods (e.g., combination of condom, diaphragm, or intrauterine device), hormonal contraception (estrogen or progesterone agents) or 1 barrier method in combination with spermicide. Birth control is required 1 month prior to screening, for the duration of their study participation, and for 1 month after the end of the study; female partners of male patients must adhere to the same birth control methods.\n15. Patient is willing to comply with protocol-required visit schedule and visit requirements\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Part 2 only: More than one prior chemotherapy regimen for unresectable metastatic or locally advanced BTC Note: prior radiation (with or without radiosensitizing doses of chemotherapy) or fluoropyrimidine chemotherapy are allowed as postsurgical adjuvant therapy.\n2. Part 2 only: Received any systemic therapy (chemotherapy, biologics, immunotherapy, or investigational agents) for metastatic disease other than gemcitabine based chemotherapy or CCRT for locally advanced BTC\n3. Diagnosis of active malignancy (other than GI cancer [Part 1] or BTC [Part 2]) within the past 2 years, except nonmelanoma skin carcinoma and carcinoma-in-situ of uterine cervix treated with curative intent\n4. Prior discontinuation of gemcitabine because of pulmonary or hepatic toxicity or hemolytic uremic syndrome (HUS) or hypersensitivity, allergic reaction, or intolerance\n5. Any GI disorder which would significantly impede absorption of an oral agent\n6. Known brain or leptomeningeal metastases\n7. Surgery or radiation therapy within the past 28 days\n8. Part 2 only: Evidence of disease progression, based on the Investigator's assessment, on the screening computed tomography (CT) scan or magnetic resonance imaging (MRI) scan\n9. Any active disease or condition that would not permit compliance with the protocol\n10. Residual toxicity from prior chemotherapy or CCRT that is Grade ≥2 (residual Grade 2 neuropathy and alopecia are permitted)\n11. Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, unstable angina, congestive heart failure, or New York Heart Association [NYHA] Grade 2 or greater), or uncontrolled serious cardiac arrhythmia\n12. Patient has a history of drug or alcohol abuse within last year\n13. Patient has documented cerebrovascular disease\n14. Patient has a seizure disorder not controlled on medication (based on decision of Investigator)\n15. Patient received an investigational agent within 28 days of enrollment\n16. Patients with uncontrolled active viral, bacterial, or systemic fungal infection\n17. Patient has known human immunodeficiency virus (HIV) infection\n18. Patient has hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection in medical history. If positive results are not indicative of true active or chronic infection, the patient can enter the study after discussion and agreement between the Investigator and the Clinical Research Organization (CRO) Medical Monitor\n19. Patient has received yellow fever vaccine or other live attenuated vaccine(s) within the 4 weeks prior to screening\n20. Patient has any other serious medical condition that, in the Investigator's medical opinion, would preclude safe participation in, and compliance with, a clinical trial",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. Provision of a signed and dated written Informed Consent Form (ICF) prior to any study specific procedures",
                "criterions": [
                    {
                        "exact_snippets": "Provision of a signed and dated written Informed Consent Form (ICF)",
                        "criterion": "Informed Consent Form (ICF)",
                        "requirement": {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Provision of a signed and dated written Informed Consent Form (ICF)",
                        "criterion": "Informed Consent Form (ICF)",
                        "requirement": {
                            "requirement_type": "signature",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Provision of a signed and dated written Informed Consent Form (ICF)",
                        "criterion": "Informed Consent Form (ICF)",
                        "requirement": {
                            "requirement_type": "date",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Provision of a signed and dated written Informed Consent Form (ICF)",
                        "criterion": "Informed Consent Form (ICF)",
                        "requirement": {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Provision of a signed and dated written Informed Consent Form (ICF)",
                        "criterion": "Informed Consent Form (ICF)",
                        "requirement": {
                            "requirement_type": "signature",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Provision of a signed and dated written Informed Consent Form (ICF)",
                        "criterion": "Informed Consent Form (ICF)",
                        "requirement": {
                            "requirement_type": "date",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Male or female patients aged 18 years or older at screening (aged 20 years or older in Taiwan)",
                "criterions": [
                    {
                        "exact_snippets": "Male or female patients",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "aged 18 years or older at screening",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "aged 20 years or older in Taiwan",
                        "criterion": "age in Taiwan",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "aged 20 years or older in Taiwan",
                    "criterion": "age in Taiwan",
                    "requirement": {
                        "requirement_type": "minimum age",
                        "expected_value": {
                            "operator": ">=",
                            "value": 20,
                            "unit": "years"
                        }
                    }
                },
                "then_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "Male or female patients",
                            "criterion": "gender",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        },
                        {
                            "exact_snippets": "aged 20 years or older in Taiwan",
                            "criterion": "age in Taiwan",
                            "requirement": {
                                "requirement_type": "minimum age",
                                "expected_value": {
                                    "operator": ">=",
                                    "value": 20,
                                    "unit": "years"
                                }
                            }
                        }
                    ]
                },
                "else_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "Male or female patients",
                            "criterion": "gender",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        },
                        {
                            "exact_snippets": "aged 18 years or older at screening",
                            "criterion": "age",
                            "requirement": {
                                "requirement_type": "minimum age",
                                "expected_value": {
                                    "operator": ">=",
                                    "value": 18,
                                    "unit": "years"
                                }
                            }
                        }
                    ]
                }
            }
        },
        {
            "identified_line": {
                "line": "3. Histopathological or cytologic diagnosis of unresectable, metastatic or locally advanced GI cancer (Part 1) or unresectable metastatic or locally advanced BTC (cholangiocarcinoma or gallbladder cancer; Part 2)",
                "criterions": [
                    {
                        "exact_snippets": "Histopathological or cytologic diagnosis",
                        "criterion": "diagnosis method",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": [
                                "histopathological",
                                "cytologic"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "unresectable, metastatic or locally advanced GI cancer (Part 1)",
                        "criterion": "GI cancer",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "unresectable",
                                "metastatic",
                                "locally advanced"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "unresectable metastatic or locally advanced BTC (cholangiocarcinoma or gallbladder cancer; Part 2)",
                        "criterion": "BTC (cholangiocarcinoma or gallbladder cancer)",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "unresectable",
                                "metastatic",
                                "locally advanced"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Histopathological or cytologic diagnosis",
                                "criterion": "diagnosis method",
                                "requirement": {
                                    "requirement_type": "method",
                                    "expected_value": [
                                        "histopathological",
                                        "cytologic"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "unresectable, metastatic or locally advanced GI cancer (Part 1)",
                                "criterion": "GI cancer",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": [
                                        "unresectable",
                                        "metastatic",
                                        "locally advanced"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Histopathological or cytologic diagnosis",
                                "criterion": "diagnosis method",
                                "requirement": {
                                    "requirement_type": "method",
                                    "expected_value": [
                                        "histopathological",
                                        "cytologic"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "unresectable metastatic or locally advanced BTC (cholangiocarcinoma or gallbladder cancer; Part 2)",
                                "criterion": "BTC (cholangiocarcinoma or gallbladder cancer)",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": [
                                        "unresectable",
                                        "metastatic",
                                        "locally advanced"
                                    ]
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Part 1 only: Refractory to or have relapsed from all standard therapies of advanced GI malignancy",
                "criterions": [
                    {
                        "exact_snippets": "Refractory to ... all standard therapies",
                        "criterion": "refractory to standard therapies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "relapsed from all standard therapies",
                        "criterion": "relapsed from standard therapies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "advanced GI malignancy",
                        "criterion": "advanced GI malignancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Refractory to ... all standard therapies",
                                "criterion": "refractory to standard therapies",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "relapsed from all standard therapies",
                                "criterion": "relapsed from standard therapies",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "advanced GI malignancy",
                        "criterion": "advanced GI malignancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Part 2 only:",
                "criterions": [
                    {
                        "exact_snippets": "Part 2 only",
                        "criterion": "trial part",
                        "requirement": {
                            "requirement_type": "specificity",
                            "expected_value": "Part 2"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Part 2 only",
                        "criterion": "trial part",
                        "requirement": {
                            "requirement_type": "specificity",
                            "expected_value": "Part 2"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. Achieved stable disease or better, based on the Investigator's assessment, in response to first line systemic therapy or CCRT, with continued stable disease or better based on imaging studies obtained as part of screening",
                "criterions": [
                    {
                        "exact_snippets": "Achieved stable disease or better, based on the Investigator's assessment, in response to first line systemic therapy or CCRT",
                        "criterion": "response to first line systemic therapy or CCRT",
                        "requirement": {
                            "requirement_type": "response",
                            "expected_value": [
                                "stable disease",
                                "better"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "continued stable disease or better based on imaging studies obtained as part of screening",
                        "criterion": "imaging studies",
                        "requirement": {
                            "requirement_type": "response",
                            "expected_value": [
                                "stable disease",
                                "better"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Achieved stable disease or better, based on the Investigator's assessment, in response to first line systemic therapy or CCRT",
                                "criterion": "response to first line systemic therapy or CCRT",
                                "requirement": {
                                    "requirement_type": "response",
                                    "expected_value": [
                                        "stable disease",
                                        "better"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "continued stable disease or better based on imaging studies obtained as part of screening",
                                "criterion": "imaging studies",
                                "requirement": {
                                    "requirement_type": "response",
                                    "expected_value": [
                                        "stable disease",
                                        "better"
                                    ]
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Completed first line systemic therapy (with 2-8 cycles of chemotherapy with a gemcitabine based regimen) or CCRT, based on the local standard of care and preferences in the participating countries Note: No more than 30% of patients enrolled in Part 2 will have received CCRT",
                "criterions": [
                    {
                        "exact_snippets": "Completed first line systemic therapy",
                        "criterion": "first line systemic therapy",
                        "requirement": {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "2-8 cycles of chemotherapy",
                        "criterion": "cycles of chemotherapy",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "cycles"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 8,
                                        "unit": "cycles"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "gemcitabine based regimen",
                        "criterion": "chemotherapy regimen",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "gemcitabine based"
                        }
                    },
                    {
                        "exact_snippets": "CCRT",
                        "criterion": "CCRT",
                        "requirement": {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Completed first line systemic therapy",
                                "criterion": "first line systemic therapy",
                                "requirement": {
                                    "requirement_type": "completion",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "2-8 cycles of chemotherapy",
                                "criterion": "cycles of chemotherapy",
                                "requirement": {
                                    "requirement_type": "range",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": ">=",
                                                "value": 2,
                                                "unit": "cycles"
                                            },
                                            {
                                                "operator": "<=",
                                                "value": 8,
                                                "unit": "cycles"
                                            }
                                        ]
                                    }
                                }
                            },
                            {
                                "exact_snippets": "gemcitabine based regimen",
                                "criterion": "chemotherapy regimen",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": "gemcitabine based"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "CCRT",
                        "criterion": "CCRT",
                        "requirement": {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. No more than 60 days have elapsed between completion of the prior line of chemotherapy or CCRT and enrollment",
                "criterions": [
                    {
                        "exact_snippets": "No more than 60 days have elapsed between completion of the prior line of chemotherapy or CCRT and enrollment",
                        "criterion": "time elapsed since prior treatment",
                        "requirement": {
                            "requirement_type": "maximum duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 60,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No more than 60 days have elapsed between completion of the prior line of chemotherapy or CCRT and enrollment",
                        "criterion": "time elapsed since prior treatment",
                        "requirement": {
                            "requirement_type": "maximum duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 60,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Part 2 only: Patient has not received intervening systemic therapy since first line treatment",
                "criterions": [
                    {
                        "exact_snippets": "Patient has not received intervening systemic therapy since first line treatment",
                        "criterion": "intervening systemic therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patient has not received intervening systemic therapy since first line treatment",
                        "criterion": "intervening systemic therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Part 2 only",
                        "criterion": "trial part",
                        "requirement": {
                            "requirement_type": "participation",
                            "expected_value": "Part 2"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2 in Part 1 and 0-1 in Part 2",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2 in Part 1",
                        "criterion": "ECOG Performance Status in Part 1",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ... 0-1 in Part 2",
                        "criterion": "ECOG Performance Status in Part 2",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "xor_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2 in Part 1",
                                "criterion": "ECOG Performance Status in Part 1",
                                "requirement": {
                                    "requirement_type": "range",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": ">=",
                                                "value": 0,
                                                "unit": "N/A"
                                            },
                                            {
                                                "operator": "<=",
                                                "value": 2,
                                                "unit": "N/A"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ... 0-1 in Part 2",
                                "criterion": "ECOG Performance Status in Part 2",
                                "requirement": {
                                    "requirement_type": "range",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": ">=",
                                                "value": 0,
                                                "unit": "N/A"
                                            },
                                            {
                                                "operator": "<=",
                                                "value": 1,
                                                "unit": "N/A"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. Life expectancy is >12 weeks",
                "criterions": [
                    {
                        "exact_snippets": "Life expectancy is >12 weeks",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Life expectancy is >12 weeks",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "10. Adequate bone marrow function, demonstrated by:",
                "criterions": [
                    {
                        "exact_snippets": "Adequate bone marrow function",
                        "criterion": "bone marrow function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate bone marrow function",
                        "criterion": "bone marrow function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. Absolute neutrophil count (ANC) ≥1,500 cell/mm3",
                "criterions": [
                    {
                        "exact_snippets": "Absolute neutrophil count (ANC) ≥1,500 cell/mm3",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "cell/mm3"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Absolute neutrophil count (ANC) ≥1,500 cell/mm3",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "cell/mm3"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Platelet count ≥100,000 cells/mm3",
                "criterions": [
                    {
                        "exact_snippets": "Platelet count ≥100,000 cells/mm3",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "cells/mm3"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Platelet count ≥100,000 cells/mm3",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "cells/mm3"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Hemoglobin ≥9 g/dL",
                "criterions": [
                    {
                        "exact_snippets": "Hemoglobin ≥9 g/dL",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hemoglobin ≥9 g/dL",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "11. Adequate liver function, demonstrated by:",
                "criterions": [
                    {
                        "exact_snippets": "Adequate liver function",
                        "criterion": "liver function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate liver function",
                        "criterion": "liver function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 x upper limit of normal (ULN), or ≤5.0 x ULN in the case of liver metastases",
                "criterions": [
                    {
                        "exact_snippets": "Aspartate transaminase (AST) ... ≤2.5 x upper limit of normal (ULN), or ≤5.0 x ULN in the case of liver metastases",
                        "criterion": "Aspartate transaminase (AST)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Aspartate transaminase (AST) ... ≤2.5 x upper limit of normal (ULN), or ≤5.0 x ULN in the case of liver metastases",
                        "criterion": "Aspartate transaminase (AST)",
                        "requirement": {
                            "requirement_type": "level with liver metastases",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5.0,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "alanine transaminase (ALT) ≤2.5 x upper limit of normal (ULN), or ≤5.0 x ULN in the case of liver metastases",
                        "criterion": "alanine transaminase (ALT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "alanine transaminase (ALT) ≤2.5 x upper limit of normal (ULN), or ≤5.0 x ULN in the case of liver metastases",
                        "criterion": "alanine transaminase (ALT)",
                        "requirement": {
                            "requirement_type": "level with liver metastases",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5.0,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Aspartate transaminase (AST) ... ≤2.5 x upper limit of normal (ULN), or ≤5.0 x ULN in the case of liver metastases",
                                        "criterion": "Aspartate transaminase (AST)",
                                        "requirement": {
                                            "requirement_type": "level",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": "<=",
                                                        "value": 2.5,
                                                        "unit": "x ULN"
                                                    }
                                                ]
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "alanine transaminase (ALT) ≤2.5 x upper limit of normal (ULN), or ≤5.0 x ULN in the case of liver metastases",
                                        "criterion": "alanine transaminase (ALT)",
                                        "requirement": {
                                            "requirement_type": "level",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": "<=",
                                                        "value": 2.5,
                                                        "unit": "x ULN"
                                                    }
                                                ]
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Aspartate transaminase (AST) ... ≤2.5 x upper limit of normal (ULN), or ≤5.0 x ULN in the case of liver metastases",
                                        "criterion": "Aspartate transaminase (AST)",
                                        "requirement": {
                                            "requirement_type": "level with liver metastases",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": "<=",
                                                        "value": 5.0,
                                                        "unit": "x ULN"
                                                    }
                                                ]
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "alanine transaminase (ALT) ≤2.5 x upper limit of normal (ULN), or ≤5.0 x ULN in the case of liver metastases",
                                        "criterion": "alanine transaminase (ALT)",
                                        "requirement": {
                                            "requirement_type": "level with liver metastases",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": "<=",
                                                        "value": 5.0,
                                                        "unit": "x ULN"
                                                    }
                                                ]
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Albumin ≥3.0 g/dL",
                "criterions": [
                    {
                        "exact_snippets": "Albumin ≥3.0 g/dL",
                        "criterion": "albumin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3.0,
                                "unit": "g/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Albumin ≥3.0 g/dL",
                        "criterion": "albumin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3.0,
                                "unit": "g/dL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. International normalized ratio (INR) <1.5",
                "criterions": [
                    {
                        "exact_snippets": "International normalized ratio (INR) <1.5",
                        "criterion": "International normalized ratio (INR)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "International normalized ratio (INR) <1.5",
                        "criterion": "International normalized ratio (INR)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "12. Adequate renal function, demonstrated by:",
                "criterions": [
                    {
                        "exact_snippets": "Adequate renal function",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate renal function",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. Serum creatinine ≤1.5 x ULN",
                "criterions": [
                    {
                        "exact_snippets": "Serum creatinine ≤1.5 x ULN",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Serum creatinine ≤1.5 x ULN",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "13. If a woman of childbearing potential, the patient has a negative serum pregnancy test at screening and is not breastfeeding",
                "criterions": [
                    {
                        "exact_snippets": "woman of childbearing potential",
                        "criterion": "woman of childbearing potential",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "negative serum pregnancy test",
                        "criterion": "serum pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "not breastfeeding",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "woman of childbearing potential",
                    "criterion": "woman of childbearing potential",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "negative serum pregnancy test",
                            "criterion": "serum pregnancy test",
                            "requirement": {
                                "requirement_type": "result",
                                "expected_value": "negative"
                            }
                        },
                        {
                            "exact_snippets": "not breastfeeding",
                            "criterion": "breastfeeding",
                            "requirement": {
                                "requirement_type": "status",
                                "expected_value": false
                            }
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "14. If a woman of childbearing potential, patient must use a medically acceptable form of contraception as 2 barrier methods (e.g., combination of condom, diaphragm, or intrauterine device), hormonal contraception (estrogen or progesterone agents) or 1 barrier method in combination with spermicide. Birth control is required 1 month prior to screening, for the duration of their study participation, and for 1 month after the end of the study; female partners of male patients must adhere to the same birth control methods.",
                "criterions": [
                    {
                        "exact_snippets": "woman of childbearing potential",
                        "criterion": "woman of childbearing potential",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "patient must use a medically acceptable form of contraception",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "2 barrier methods (e.g., combination of condom, diaphragm, or intrauterine device)",
                        "criterion": "barrier methods",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "methods"
                            }
                        }
                    },
                    {
                        "exact_snippets": "hormonal contraception (estrogen or progesterone agents)",
                        "criterion": "hormonal contraception",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "1 barrier method in combination with spermicide",
                        "criterion": "barrier method with spermicide",
                        "requirement": {
                            "requirement_type": "combination",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Birth control is required 1 month prior to screening",
                        "criterion": "birth control duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "1 month prior to screening"
                        }
                    },
                    {
                        "exact_snippets": "for the duration of their study participation",
                        "criterion": "birth control duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "for the duration of study participation"
                        }
                    },
                    {
                        "exact_snippets": "for 1 month after the end of the study",
                        "criterion": "birth control duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "1 month after the end of the study"
                        }
                    },
                    {
                        "exact_snippets": "female partners of male patients must adhere to the same birth control methods",
                        "criterion": "female partners of male patients birth control",
                        "requirement": {
                            "requirement_type": "adherence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "woman of childbearing potential",
                    "criterion": "woman of childbearing potential",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "and_criteria": [
                        {
                            "or_criteria": [
                                {
                                    "and_criteria": [
                                        {
                                            "exact_snippets": "patient must use a medically acceptable form of contraception",
                                            "criterion": "contraception use",
                                            "requirement": {
                                                "requirement_type": "presence",
                                                "expected_value": true
                                            }
                                        },
                                        {
                                            "exact_snippets": "2 barrier methods (e.g., combination of condom, diaphragm, or intrauterine device)",
                                            "criterion": "barrier methods",
                                            "requirement": {
                                                "requirement_type": "quantity",
                                                "expected_value": {
                                                    "operator": ">=",
                                                    "value": 2,
                                                    "unit": "methods"
                                                }
                                            }
                                        }
                                    ]
                                },
                                {
                                    "exact_snippets": "hormonal contraception (estrogen or progesterone agents)",
                                    "criterion": "hormonal contraception",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "exact_snippets": "1 barrier method in combination with spermicide",
                                    "criterion": "barrier method with spermicide",
                                    "requirement": {
                                        "requirement_type": "combination",
                                        "expected_value": true
                                    }
                                }
                            ]
                        },
                        {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Birth control is required 1 month prior to screening",
                                    "criterion": "birth control duration",
                                    "requirement": {
                                        "requirement_type": "duration",
                                        "expected_value": "1 month prior to screening"
                                    }
                                },
                                {
                                    "exact_snippets": "for the duration of their study participation",
                                    "criterion": "birth control duration",
                                    "requirement": {
                                        "requirement_type": "duration",
                                        "expected_value": "for the duration of study participation"
                                    }
                                },
                                {
                                    "exact_snippets": "for 1 month after the end of the study",
                                    "criterion": "birth control duration",
                                    "requirement": {
                                        "requirement_type": "duration",
                                        "expected_value": "1 month after the end of the study"
                                    }
                                }
                            ]
                        },
                        {
                            "exact_snippets": "female partners of male patients must adhere to the same birth control methods",
                            "criterion": "female partners of male patients birth control",
                            "requirement": {
                                "requirement_type": "adherence",
                                "expected_value": true
                            }
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "15. Patient is willing to comply with protocol-required visit schedule and visit requirements",
                "criterions": [
                    {
                        "exact_snippets": "Patient is willing to comply with protocol-required visit schedule and visit requirements",
                        "criterion": "willingness to comply with protocol",
                        "requirement": {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patient is willing to comply with protocol-required visit schedule and visit requirements",
                        "criterion": "willingness to comply with protocol",
                        "requirement": {
                            "requirement_type": "compliance",
                            "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"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "1. Part 2 only: More than one prior chemotherapy regimen for unresectable metastatic or locally advanced BTC Note: prior radiation (with or without radiosensitizing doses of chemotherapy) or fluoropyrimidine chemotherapy are allowed as postsurgical adjuvant therapy.",
                "criterions": [
                    {
                        "exact_snippets": "More than one prior chemotherapy regimen for unresectable metastatic or locally advanced BTC",
                        "criterion": "prior chemotherapy regimen",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "regimen"
                            }
                        }
                    },
                    {
                        "exact_snippets": "prior radiation (with or without radiosensitizing doses of chemotherapy) ... are allowed as postsurgical adjuvant therapy",
                        "criterion": "prior radiation",
                        "requirement": {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "fluoropyrimidine chemotherapy are allowed as postsurgical adjuvant therapy",
                        "criterion": "fluoropyrimidine chemotherapy",
                        "requirement": {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "More than one prior chemotherapy regimen for unresectable metastatic or locally advanced BTC",
                                    "criterion": "prior chemotherapy regimen",
                                    "requirement": {
                                        "requirement_type": "quantity",
                                        "expected_value": {
                                            "operator": ">",
                                            "value": 1,
                                            "unit": "regimen"
                                        }
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "exact_snippets": "prior radiation (with or without radiosensitizing doses of chemotherapy) ... are allowed as postsurgical adjuvant therapy",
                                        "criterion": "prior radiation",
                                        "requirement": {
                                            "requirement_type": "allowance",
                                            "expected_value": true
                                        }
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "exact_snippets": "fluoropyrimidine chemotherapy are allowed as postsurgical adjuvant therapy",
                                        "criterion": "fluoropyrimidine chemotherapy",
                                        "requirement": {
                                            "requirement_type": "allowance",
                                            "expected_value": true
                                        }
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Part 2 only: Received any systemic therapy (chemotherapy, biologics, immunotherapy, or investigational agents) for metastatic disease other than gemcitabine based chemotherapy or CCRT for locally advanced BTC",
                "criterions": [
                    {
                        "exact_snippets": "Received any systemic therapy (chemotherapy, biologics, immunotherapy, or investigational agents) for metastatic disease",
                        "criterion": "systemic therapy for metastatic disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "other than gemcitabine based chemotherapy",
                        "criterion": "gemcitabine based chemotherapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "CCRT for locally advanced BTC",
                        "criterion": "CCRT for locally advanced BTC",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Received any systemic therapy (chemotherapy, biologics, immunotherapy, or investigational agents) for metastatic disease",
                                "criterion": "systemic therapy for metastatic disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "other than gemcitabine based chemotherapy",
                                    "criterion": "gemcitabine based chemotherapy",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": false
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "CCRT for locally advanced BTC",
                            "criterion": "CCRT for locally advanced BTC",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Prior discontinuation of gemcitabine because of pulmonary or hepatic toxicity or hemolytic uremic syndrome (HUS) or hypersensitivity, allergic reaction, or intolerance",
                "criterions": [
                    {
                        "exact_snippets": "Prior discontinuation of gemcitabine because of pulmonary ... toxicity",
                        "criterion": "pulmonary toxicity",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior discontinuation of gemcitabine because of ... hepatic toxicity",
                        "criterion": "hepatic toxicity",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior discontinuation of gemcitabine because of ... hemolytic uremic syndrome (HUS)",
                        "criterion": "hemolytic uremic syndrome (HUS)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior discontinuation of gemcitabine because of ... hypersensitivity",
                        "criterion": "hypersensitivity",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior discontinuation of gemcitabine because of ... allergic reaction",
                        "criterion": "allergic reaction",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior discontinuation of gemcitabine because of ... intolerance",
                        "criterion": "intolerance",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Prior discontinuation of gemcitabine because of pulmonary ... toxicity",
                                "criterion": "pulmonary toxicity",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Prior discontinuation of gemcitabine because of pulmonary ... toxicity",
                                "criterion": "gemcitabine discontinuation",
                                "requirement": {
                                    "requirement_type": "cause",
                                    "expected_value": "pulmonary toxicity"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Prior discontinuation of gemcitabine because of ... hepatic toxicity",
                                "criterion": "hepatic toxicity",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Prior discontinuation of gemcitabine because of ... hepatic toxicity",
                                "criterion": "gemcitabine discontinuation",
                                "requirement": {
                                    "requirement_type": "cause",
                                    "expected_value": "hepatic toxicity"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Prior discontinuation of gemcitabine because of ... hemolytic uremic syndrome (HUS)",
                                "criterion": "hemolytic uremic syndrome (HUS)",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Prior discontinuation of gemcitabine because of ... hemolytic uremic syndrome (HUS)",
                                "criterion": "gemcitabine discontinuation",
                                "requirement": {
                                    "requirement_type": "cause",
                                    "expected_value": "hemolytic uremic syndrome (HUS)"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Prior discontinuation of gemcitabine because of ... hypersensitivity",
                                "criterion": "hypersensitivity",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Prior discontinuation of gemcitabine because of ... hypersensitivity",
                                "criterion": "gemcitabine discontinuation",
                                "requirement": {
                                    "requirement_type": "cause",
                                    "expected_value": "hypersensitivity"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Prior discontinuation of gemcitabine because of ... allergic reaction",
                                "criterion": "allergic reaction",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Prior discontinuation of gemcitabine because of ... allergic reaction",
                                "criterion": "gemcitabine discontinuation",
                                "requirement": {
                                    "requirement_type": "cause",
                                    "expected_value": "allergic reaction"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Prior discontinuation of gemcitabine because of ... intolerance",
                                "criterion": "intolerance",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Prior discontinuation of gemcitabine because of ... intolerance",
                                "criterion": "gemcitabine discontinuation",
                                "requirement": {
                                    "requirement_type": "cause",
                                    "expected_value": "intolerance"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Any GI disorder which would significantly impede absorption of an oral agent",
                "criterions": [
                    {
                        "exact_snippets": "GI disorder which would significantly impede absorption of an oral agent",
                        "criterion": "GI disorder",
                        "requirement": {
                            "requirement_type": "impact on absorption",
                            "expected_value": "significantly impede"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "GI disorder which would significantly impede absorption of an oral agent",
                    "criterion": "GI disorder",
                    "requirement": {
                        "requirement_type": "impact on absorption",
                        "expected_value": "significantly impede"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "6. Known brain or leptomeningeal metastases",
                "criterions": [
                    {
                        "exact_snippets": "Known brain or leptomeningeal metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Known brain or leptomeningeal metastases",
                        "criterion": "leptomeningeal metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Known brain or leptomeningeal metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Known brain or leptomeningeal metastases",
                        "criterion": "leptomeningeal metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Surgery or radiation therapy within the past 28 days",
                "criterions": [
                    {
                        "exact_snippets": "Surgery ... within the past 28 days",
                        "criterion": "surgery",
                        "requirement": {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "radiation therapy within the past 28 days",
                        "criterion": "radiation therapy",
                        "requirement": {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Surgery ... within the past 28 days",
                        "criterion": "surgery",
                        "requirement": {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "radiation therapy within the past 28 days",
                        "criterion": "radiation therapy",
                        "requirement": {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Part 2 only: Evidence of disease progression, based on the Investigator's assessment, on the screening computed tomography (CT) scan or magnetic resonance imaging (MRI) scan",
                "criterions": [
                    {
                        "exact_snippets": "Evidence of disease progression ... on the screening computed tomography (CT) scan or magnetic resonance imaging (MRI) scan",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Evidence of disease progression ... on the screening computed tomography (CT) scan or magnetic resonance imaging (MRI) scan",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "11. Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, unstable angina, congestive heart failure, or New York Heart Association [NYHA] Grade 2 or greater), or uncontrolled serious cardiac arrhythmia",
                "criterions": [
                    {
                        "exact_snippets": "Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, unstable angina, congestive heart failure, or New York Heart Association [NYHA] Grade 2 or greater)",
                        "criterion": "cardiovascular disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled hypertension",
                        "criterion": "hypertension",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "unstable angina",
                        "criterion": "angina",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "congestive heart failure",
                        "criterion": "heart failure",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "congestive"
                        }
                    },
                    {
                        "exact_snippets": "New York Heart Association [NYHA] Grade 2 or greater",
                        "criterion": "NYHA grade",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled serious cardiac arrhythmia",
                        "criterion": "cardiac arrhythmia",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled serious cardiac arrhythmia",
                        "criterion": "cardiac arrhythmia",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, unstable angina, congestive heart failure, or New York Heart Association [NYHA] Grade 2 or greater)",
                                "criterion": "cardiovascular disease",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "clinically significant"
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "uncontrolled hypertension",
                                        "criterion": "hypertension",
                                        "requirement": {
                                            "requirement_type": "control",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "unstable angina",
                                        "criterion": "angina",
                                        "requirement": {
                                            "requirement_type": "stability",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "congestive heart failure",
                                        "criterion": "heart failure",
                                        "requirement": {
                                            "requirement_type": "type",
                                            "expected_value": "congestive"
                                        }
                                    },
                                    {
                                        "exact_snippets": "New York Heart Association [NYHA] Grade 2 or greater",
                                        "criterion": "NYHA grade",
                                        "requirement": {
                                            "requirement_type": "severity",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 2,
                                                "unit": "grade"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "uncontrolled serious cardiac arrhythmia",
                                "criterion": "cardiac arrhythmia",
                                "requirement": {
                                    "requirement_type": "control",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "uncontrolled serious cardiac arrhythmia",
                                "criterion": "cardiac arrhythmia",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "serious"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "12. Patient has a history of drug or alcohol abuse within last year",
                "criterions": [
                    {
                        "exact_snippets": "history of drug or alcohol abuse within last year",
                        "criterion": "drug or alcohol abuse",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "history of drug or alcohol abuse within last year",
                        "criterion": "drug or alcohol abuse",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within last year"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "history of drug or alcohol abuse within last year",
                        "criterion": "drug or alcohol abuse",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "history of drug or alcohol abuse within last year",
                        "criterion": "drug or alcohol abuse",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within last year"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "13. Patient has documented cerebrovascular disease",
                "criterions": [
                    {
                        "exact_snippets": "documented cerebrovascular disease",
                        "criterion": "cerebrovascular disease",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "documented cerebrovascular disease",
                    "criterion": "cerebrovascular disease",
                    "requirement": {
                        "requirement_type": "documentation",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "14. Patient has a seizure disorder not controlled on medication (based on decision of Investigator)",
                "criterions": [
                    {
                        "exact_snippets": "seizure disorder not controlled on medication",
                        "criterion": "seizure disorder",
                        "requirement": {
                            "requirement_type": "control status",
                            "expected_value": "not controlled on medication"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "seizure disorder not controlled on medication",
                                "criterion": "seizure disorder",
                                "requirement": {
                                    "requirement_type": "control status",
                                    "expected_value": "not controlled on medication"
                                }
                            },
                            {
                                "exact_snippets": "based on decision of Investigator",
                                "criterion": "decision of Investigator",
                                "requirement": {
                                    "requirement_type": "approval",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "15. Patient received an investigational agent within 28 days of enrollment",
                "criterions": [
                    {
                        "exact_snippets": "Patient received an investigational agent within 28 days of enrollment",
                        "criterion": "investigational agent",
                        "requirement": {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Patient received an investigational agent within 28 days of enrollment",
                    "criterion": "investigational agent",
                    "requirement": {
                        "requirement_type": "time since last administration",
                        "expected_value": {
                            "operator": "<=",
                            "value": 28,
                            "unit": "days"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "16. Patients with uncontrolled active viral, bacterial, or systemic fungal infection",
                "criterions": [
                    {
                        "exact_snippets": "uncontrolled active viral, bacterial, or systemic fungal infection",
                        "criterion": "viral infection",
                        "requirement": {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled active"
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled active viral, bacterial, or systemic fungal infection",
                        "criterion": "bacterial infection",
                        "requirement": {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled active"
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled active viral, bacterial, or systemic fungal infection",
                        "criterion": "systemic fungal infection",
                        "requirement": {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled active"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "uncontrolled active viral, bacterial, or systemic fungal infection",
                        "criterion": "viral infection",
                        "requirement": {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled active"
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled active viral, bacterial, or systemic fungal infection",
                        "criterion": "bacterial infection",
                        "requirement": {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled active"
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled active viral, bacterial, or systemic fungal infection",
                        "criterion": "systemic fungal infection",
                        "requirement": {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled active"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "17. Patient has known human immunodeficiency virus (HIV) infection",
                "criterions": [
                    {
                        "exact_snippets": "Patient has known human immunodeficiency virus (HIV) infection",
                        "criterion": "HIV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Patient has known human immunodeficiency virus (HIV) infection",
                    "criterion": "HIV infection",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "18. Patient has hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection in medical history. If positive results are not indicative of true active or chronic infection, the patient can enter the study after discussion and agreement between the Investigator and the Clinical Research Organization (CRO) Medical Monitor",
                "criterions": [
                    {
                        "exact_snippets": "Patient has hepatitis B virus (HBV) ... infection in medical history",
                        "criterion": "hepatitis B virus (HBV) infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Patient has ... hepatitis C virus (HCV) infection in medical history",
                        "criterion": "hepatitis C virus (HCV) infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
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                        {
                            "exact_snippets": "Patient has hepatitis B virus (HBV) ... infection in medical history",
                            "criterion": "hepatitis B virus (HBV) infection",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        },
                        {
                            "exact_snippets": "Patient has ... hepatitis C virus (HCV) infection in medical history",
                            "criterion": "hepatitis C virus (HCV) infection",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        }
                    ]
                },
                "then_criteria": {
                    "not_criteria": {
                        "condition": {
                            "exact_snippets": "If positive results are not indicative of true active or chronic infection",
                            "criterion": "positive results indicative of true active or chronic infection",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        },
                        "then_criteria": null,
                        "else_criteria": null
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "19. Patient has received yellow fever vaccine or other live attenuated vaccine(s) within the 4 weeks prior to screening",
                "criterions": [
                    {
                        "exact_snippets": "Patient has received yellow fever vaccine",
                        "criterion": "yellow fever vaccine",
                        "requirement": {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Patient has received yellow fever vaccine",
                        "criterion": "yellow fever vaccine",
                        "requirement": {
                            "requirement_type": "time since receipt",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "other live attenuated vaccine(s)",
                        "criterion": "live attenuated vaccine",
                        "requirement": {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "other live attenuated vaccine(s)",
                        "criterion": "live attenuated vaccine",
                        "requirement": {
                            "requirement_type": "time since receipt",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Patient has received yellow fever vaccine",
                                "criterion": "yellow fever vaccine",
                                "requirement": {
                                    "requirement_type": "receipt",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Patient has received yellow fever vaccine",
                                "criterion": "yellow fever vaccine",
                                "requirement": {
                                    "requirement_type": "time since receipt",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "other live attenuated vaccine(s)",
                                "criterion": "live attenuated vaccine",
                                "requirement": {
                                    "requirement_type": "receipt",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "other live attenuated vaccine(s)",
                                "criterion": "live attenuated vaccine",
                                "requirement": {
                                    "requirement_type": "time since receipt",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "2. Total bilirubin ≤1.5 x ULN",
                "criterions": [
                    {
                        "exact_snippets": "Total bilirubin ≤1.5 x ULN",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Total bilirubin \u00141.5 x ULN",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Creatinine clearance ≥ 60 mL/min calculated by Cockcroft-Gault formula or directly measured with 24 hr urine collection",
                "criterions": [
                    {
                        "exact_snippets": "Creatinine clearance ≥ 60 mL/min",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    },
                    {
                        "exact_snippets": "calculated by Cockcroft-Gault formula",
                        "criterion": "creatinine clearance calculation method",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": "Cockcroft-Gault formula"
                        }
                    },
                    {
                        "exact_snippets": "directly measured with 24 hr urine collection",
                        "criterion": "creatinine clearance measurement method",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": "24 hr urine collection"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "3. Diagnosis of active malignancy (other than GI cancer [Part 1] or BTC [Part 2]) within the past 2 years, except nonmelanoma skin carcinoma and carcinoma-in-situ of uterine cervix treated with curative intent",
                "criterions": [
                    {
                        "exact_snippets": "Diagnosis of active malignancy (other than GI cancer [Part 1] or BTC [Part 2]) within the past 2 years",
                        "criterion": "active malignancy diagnosis",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Diagnosis of active malignancy (other than GI cancer [Part 1] or BTC [Part 2]) within the past 2 years",
                        "criterion": "active malignancy diagnosis",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "GI cancer",
                                "BTC"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "except nonmelanoma skin carcinoma and carcinoma-in-situ of uterine cervix treated with curative intent",
                        "criterion": "active malignancy diagnosis",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "nonmelanoma skin carcinoma",
                                "carcinoma-in-situ of uterine cervix treated with curative intent"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "9. Any active disease or condition that would not permit compliance with the protocol",
                "criterions": [
                    {
                        "exact_snippets": "Any active disease or condition",
                        "criterion": "active disease or condition",
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                            "requirement_type": "presence",
                            "expected_value": false
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                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Any active disease or condition",
                        "criterion": "active disease or condition",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "that would not permit compliance with the protocol",
                        "criterion": "compliance with the protocol",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": false
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                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "10. Residual toxicity from prior chemotherapy or CCRT that is Grade ≥2 (residual Grade 2 neuropathy and alopecia are permitted)",
                "criterions": [
                    {
                        "exact_snippets": "Residual toxicity from prior chemotherapy or CCRT that is Grade ≥2",
                        "criterion": "residual toxicity from prior chemotherapy or CCRT",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "residual Grade 2 neuropathy and alopecia are permitted",
                        "criterion": "residual neuropathy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "residual Grade 2 neuropathy and alopecia are permitted",
                        "criterion": "residual neuropathy",
                        "requirement": {
                            "requirement_type": "permitted",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "residual Grade 2 neuropathy and alopecia are permitted",
                        "criterion": "alopecia",
                        "requirement": {
                            "requirement_type": "permitted",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
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                    "requirement_type": "failed",
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                }
            }
        },
        {
            "identified_line": {
                "line": "20. Patient has any other serious medical condition that, in the Investigator's medical opinion, would preclude safe participation in, and compliance with, a clinical trial",
                "criterions": [
                    {
                        "exact_snippets": "any other serious medical condition",
                        "criterion": "serious medical condition",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
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            "logical_structure": {
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                    {
                        "exact_snippets": "any other serious medical condition",
                        "criterion": "serious medical condition",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "in the Investigator's medical opinion, would preclude safe participation in, and compliance with, a clinical trial",
                        "criterion": "investigator's medical opinion on trial safety and compliance",
                        "requirement": {
                            "requirement_type": "opinion",
                            "expected_value": "would preclude safe participation and compliance"
                        }
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}