{
    "info": {
        "nct_id": "NCT06799065",
        "official_title": "A Phase 1/2, Open-Label, Dose-Escalation and Expansion First-In-Human Study of ATX-295, an Oral Inhibitor of the Kinesin Motor Protein KIF18A, in Patients With Locally Advanced or Metastatic Solid Tumors, Including High-Grade Serous Ovarian Cancer",
        "inclusion_criteria": "* Patients with histologically confirmed solid tumors who have locally recurrent or metastatic disease, including HGSOC\n* Refractory to or relapsed after all standard therapies with proven clinical benefit, unless as deemed by the Investigator, the subject is not a candidate for standard treatment, there is no standard treatment, or the subject refuses standard treatment after expressing an understanding of all available therapies with proven clinical benefit\n* For the expansion cohorts, participants must have histological confirmation of HGSOC and be determined to be platinum-resistant, platinum-refractory, or platinum-intolerant\n* There is no limit to the number of prior treatment regimens\n* Have measurable or evaluable disease\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n\nKey\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Clinically unstable central nervous system (CNS) tumors or brain metastasis\n* Any other concurrent anti-cancer treatment, except for hormonal blockade\n* Has undergone a major surgery within 3 weeks of starting study treatment\n* Medical issue that limits oral ingestion or impairment of gastrointestinal function that is expected to significantly reduce the absorption of ATX-295, however participants with a functioning distal ileostomy or colostomy may be permitted on trial\n* Clinically significant (ie, active) or uncontrolled cardiovascular disease\n* Need to use proton pump inhibitors on study or H2-receptor antagonists for the dose escalation portion of the study.\n* Unable to transition off strong or moderate CYP3A4 inhibitors or strong inducers\n* Pregnancy or intent to breastfeed or conceive a child within the projected duration of treatment\n\nOther inclusion and exclusion criteria as defined in the study protocol",
        "miscellaneous_criteria": "Key"
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Refractory to or relapsed after all standard therapies with proven clinical benefit, unless as deemed by the Investigator, the subject is not a candidate for standard treatment, there is no standard treatment, or the subject refuses standard treatment after expressing an understanding of all available therapies with proven clinical benefit",
                "criterions": [
                    {
                        "exact_snippets": "Refractory to ... all standard therapies with proven clinical benefit",
                        "criterion": "refractory to standard therapies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "relapsed after all standard therapies with proven clinical benefit",
                        "criterion": "relapsed after standard therapies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "unless as deemed by the Investigator, the subject is not a candidate for standard treatment",
                        "criterion": "candidate for standard treatment",
                        "requirement": {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "there is no standard treatment",
                        "criterion": "availability of standard treatment",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "the subject refuses standard treatment after expressing an understanding of all available therapies with proven clinical benefit",
                        "criterion": "refusal of standard treatment",
                        "requirement": {
                            "requirement_type": "action",
                            "expected_value": "refusal"
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Refractory to ... all standard therapies with proven clinical benefit",
                                        "criterion": "refractory to standard therapies",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "relapsed after all standard therapies with proven clinical benefit",
                                        "criterion": "relapsed after standard therapies",
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                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
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                                    {
                                        "exact_snippets": "unless as deemed by the Investigator, the subject is not a candidate for standard treatment",
                                        "criterion": "candidate for standard treatment",
                                        "requirement": {
                                            "requirement_type": "eligibility",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "there is no standard treatment",
                                        "criterion": "availability of standard treatment",
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                                        }
                                    },
                                    {
                                        "exact_snippets": "the subject refuses standard treatment after expressing an understanding of all available therapies with proven clinical benefit",
                                        "criterion": "refusal of standard treatment",
                                        "requirement": {
                                            "requirement_type": "action",
                                            "expected_value": "refusal"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* For the expansion cohorts, participants must have histological confirmation of HGSOC and be determined to be platinum-resistant, platinum-refractory, or platinum-intolerant",
                "criterions": [
                    {
                        "exact_snippets": "histological confirmation of HGSOC",
                        "criterion": "HGSOC",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "platinum-resistant, platinum-refractory, or platinum-intolerant",
                        "criterion": "platinum status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "platinum-resistant",
                                "platinum-refractory",
                                "platinum-intolerant"
                            ]
                        }
                    }
                ]
            },
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                        "exact_snippets": "histological confirmation of HGSOC",
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                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "platinum-resistant, platinum-refractory, or platinum-intolerant",
                        "criterion": "platinum status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "platinum-resistant",
                                "platinum-refractory",
                                "platinum-intolerant"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* There is no limit to the number of prior treatment regimens",
                "criterions": [
                    {
                        "exact_snippets": "no limit to the number of prior treatment regimens",
                        "criterion": "prior treatment regimens",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": "no limit"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "no limit to the number of prior treatment regimens",
                        "criterion": "prior treatment regimens",
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                            "requirement_type": "quantity",
                            "expected_value": "no limit"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Have measurable or evaluable disease",
                "criterions": [
                    {
                        "exact_snippets": "measurable",
                        "criterion": "disease",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "evaluable",
                        "criterion": "disease",
                        "requirement": {
                            "requirement_type": "evaluability",
                            "expected_value": true
                        }
                    }
                ]
            },
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                    {
                        "exact_snippets": "measurable",
                        "criterion": "disease",
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                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "evaluable",
                        "criterion": "disease",
                        "requirement": {
                            "requirement_type": "evaluability",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Key",
                "criterions": [
                    {
                        "exact_snippets": "Key",
                        "criterion": "key",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Key",
                        "criterion": "key",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            }
        },
        {
            "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": "* Clinically unstable central nervous system (CNS) tumors or brain metastasis",
                "criterions": [
                    {
                        "exact_snippets": "Clinically unstable central nervous system (CNS) tumors",
                        "criterion": "central nervous system (CNS) tumors",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": "clinically unstable"
                        }
                    },
                    {
                        "exact_snippets": "Clinically unstable ... brain metastasis",
                        "criterion": "brain metastasis",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": "clinically unstable"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Clinically unstable central nervous system (CNS) tumors",
                        "criterion": "central nervous system (CNS) tumors",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": "clinically unstable"
                        }
                    },
                    {
                        "exact_snippets": "Clinically unstable ... brain metastasis",
                        "criterion": "brain metastasis",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": "clinically unstable"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has undergone a major surgery within 3 weeks of starting study treatment",
                "criterions": [
                    {
                        "exact_snippets": "Has undergone a major surgery within 3 weeks",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Has undergone a major surgery within 3 weeks",
                    "criterion": "major surgery",
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                        "requirement_type": "time since surgery",
                        "expected_value": {
                            "operator": "<=",
                            "value": 3,
                            "unit": "weeks"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Medical issue that limits oral ingestion or impairment of gastrointestinal function that is expected to significantly reduce the absorption of ATX-295, however participants with a functioning distal ileostomy or colostomy may be permitted on trial",
                "criterions": [
                    {
                        "exact_snippets": "Medical issue that limits oral ingestion",
                        "criterion": "oral ingestion",
                        "requirement": {
                            "requirement_type": "limitation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "impairment of gastrointestinal function that is expected to significantly reduce the absorption of ATX-295",
                        "criterion": "gastrointestinal function",
                        "requirement": {
                            "requirement_type": "impairment",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "participants with a functioning distal ileostomy or colostomy may be permitted",
                        "criterion": "distal ileostomy or colostomy",
                        "requirement": {
                            "requirement_type": "functioning",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
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                        {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Medical issue that limits oral ingestion",
                                    "criterion": "oral ingestion",
                                    "requirement": {
                                        "requirement_type": "limitation",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "exact_snippets": "impairment of gastrointestinal function that is expected to significantly reduce the absorption of ATX-295",
                                    "criterion": "gastrointestinal function",
                                    "requirement": {
                                        "requirement_type": "impairment",
                                        "expected_value": true
                                    }
                                }
                            ]
                        }
                    ]
                },
                "then_criteria": {
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                        "exact_snippets": "participants with a functioning distal ileostomy or colostomy may be permitted",
                        "criterion": "distal ileostomy or colostomy",
                        "requirement": {
                            "requirement_type": "functioning",
                            "expected_value": true
                        }
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Need to use proton pump inhibitors on study or H2-receptor antagonists for the dose escalation portion of the study.",
                "criterions": [
                    {
                        "exact_snippets": "Need to use proton pump inhibitors",
                        "criterion": "proton pump inhibitors",
                        "requirement": {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "H2-receptor antagonists for the dose escalation portion of the study",
                        "criterion": "H2-receptor antagonists",
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                            "requirement_type": "use",
                            "expected_value": true
                        }
                    }
                ]
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            "logical_structure": {
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                    {
                        "exact_snippets": "Need to use proton pump inhibitors",
                        "criterion": "proton pump inhibitors",
                        "requirement": {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "H2-receptor antagonists for the dose escalation portion of the study",
                        "criterion": "H2-receptor antagonists",
                        "requirement": {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Unable to transition off strong or moderate CYP3A4 inhibitors or strong inducers",
                "criterions": [
                    {
                        "exact_snippets": "Unable to transition off strong or moderate CYP3A4 inhibitors",
                        "criterion": "CYP3A4 inhibitors",
                        "requirement": {
                            "requirement_type": "transition ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Unable to transition off ... strong inducers",
                        "criterion": "CYP3A4 inducers",
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                            "requirement_type": "transition ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
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                        "and_criteria": [
                            {
                                "exact_snippets": "Unable to transition off strong or moderate CYP3A4 inhibitors",
                                "criterion": "CYP3A4 inhibitors",
                                "requirement": {
                                    "requirement_type": "transition ability",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Unable to transition off ... strong inducers",
                                "criterion": "CYP3A4 inducers",
                                "requirement": {
                                    "requirement_type": "transition ability",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Pregnancy or intent to breastfeed or conceive a child within the projected duration of treatment",
                "criterions": [
                    {
                        "exact_snippets": "Pregnancy",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "intent to breastfeed",
                        "criterion": "intent to breastfeed",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "intent to ... conceive a child within the projected duration of treatment",
                        "criterion": "intent to conceive a child",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Pregnancy",
                        "criterion": "pregnancy",
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                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "intent to breastfeed",
                        "criterion": "intent to breastfeed",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "intent to ... conceive a child within the projected duration of treatment",
                        "criterion": "intent to conceive a child",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Other inclusion and exclusion criteria as defined in the study protocol",
                "criterions": [
                    {
                        "exact_snippets": "inclusion and exclusion criteria",
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                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
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                        "expected_value": true
                    }
                }
            }
        }
    ],
    "miscellaneous_lines": [
        {
            "identified_line": {
                "line": "Key",
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                    {
                        "exact_snippets": "Tissue from tumor must be available",
                        "criterion": "tumor tissue",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Tissue from tumor ... > 2 cm in diameter.",
                        "criterion": "tumor tissue",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "cm"
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            "logical_structure": {
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                        "exact_snippets": "Tissue from tumor must be available",
                        "criterion": "tumor tissue",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Tissue from tumor ... > 2 cm in diameter.",
                        "criterion": "tumor tissue",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    }
                ]
            }
        }
    ],
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        {
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                "line": "* Patients with histologically confirmed solid tumors who have locally recurrent or metastatic disease, including HGSOC",
                "criterions": [
                    {
                        "exact_snippets": "histologically confirmed solid tumors",
                        "criterion": "solid tumors",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    },
                    {
                        "exact_snippets": "locally recurrent or metastatic disease",
                        "criterion": "disease status",
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                            "requirement_type": "status",
                            "expected_value": [
                                "locally recurrent",
                                "metastatic"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "including HGSOC",
                        "criterion": "HGSOC",
                        "requirement": {
                            "requirement_type": "inclusion",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "histologically confirmed solid tumors",
                                "criterion": "solid tumors",
                                "requirement": {
                                    "requirement_type": "confirmation",
                                    "expected_value": "histologically confirmed"
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "locally recurrent or metastatic disease",
                                        "criterion": "disease status",
                                        "requirement": {
                                            "requirement_type": "status",
                                            "expected_value": "locally recurrent"
                                        }
                                    },
                                    {
                                        "exact_snippets": "locally recurrent or metastatic disease",
                                        "criterion": "disease status",
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                                            "requirement_type": "status",
                                            "expected_value": "metastatic"
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "including HGSOC",
                        "criterion": "HGSOC",
                        "requirement": {
                            "requirement_type": "inclusion",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Any other concurrent anti-cancer treatment, except for hormonal blockade",
                "criterions": [
                    {
                        "exact_snippets": "Any other concurrent anti-cancer treatment",
                        "criterion": "concurrent anti-cancer treatment",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "except for hormonal blockade",
                        "criterion": "hormonal blockade",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Any other concurrent anti-cancer treatment",
                                    "criterion": "concurrent anti-cancer treatment",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "exact_snippets": "except for hormonal blockade",
                                        "criterion": "hormonal blockade",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Clinically significant (ie, active) or uncontrolled cardiovascular disease",
                "criterions": [
                    {
                        "exact_snippets": "Clinically significant (ie, active) or uncontrolled cardiovascular disease",
                        "criterion": "cardiovascular disease",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "clinically significant",
                                "active",
                                "uncontrolled"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Clinically significant (ie, active) or uncontrolled cardiovascular disease",
                                "criterion": "cardiovascular disease",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": "clinically significant"
                                }
                            },
                            {
                                "exact_snippets": "Clinically significant (ie, active) or uncontrolled cardiovascular disease",
                                "criterion": "cardiovascular disease",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": "active"
                                }
                            },
                            {
                                "exact_snippets": "Clinically significant (ie, active) or uncontrolled cardiovascular disease",
                                "criterion": "cardiovascular disease",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": "uncontrolled"
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}