{
    "info": {
        "nct_id": "NCT02145026",
        "official_title": "A Prospective Open-Label Study of the Effectiveness of Epoetin Beta for Treating Anemic Patients With Low/Intermediate-1-Risk Myelodysplastic Syndrome (MDS)",
        "inclusion_criteria": "* Adult participants with low or intermediate-1 risk MDS\n* No previous treatment with hematopoietic growth factors within 3 months prior to screening\n* Symptomatic anemia (hemoglobin <10 g/dL) as determined by investigator\n* Serum erythropoietin <500 milliunits/milliliter (mU/mL) within 14 days prior to the first dose of study treatment\n* Require no red blood cell transfusion or dependent on <4 units within 8 weeks prior to screening\n* Clinically stable for at least 1 month prior to entry into the study\n* For female participants of childbearing potential and male participants with partners of childbearing potential, agreement (by participants and/or partner) to use highly effective form(s) of contraception\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Contraindications and/or known hypersensitivity to the active substance and/or any of the excipients of epoetin beta treatment\n* Poorly controlled hypertension as assessed by the investigator\n* History of Acute Myeloid Leukemia (AML) or high risk for AML\n* Administration of another investigational drug within 1 month before screening or planned during the study period\n* Previously documented evidence of Pure Red Cell Aplasia (PRCA)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Adult participants with low or intermediate-1 risk MDS",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Adult participants"
                        ],
                        "criterion": "age",
                        "requirement_type": "category",
                        "expected_value": "adult"
                    },
                    {
                        "exact_snippets": [
                            "low or intermediate-1 risk MDS"
                        ],
                        "criterion": "MDS risk",
                        "requirement_type": "category",
                        "expected_value": [
                            "low",
                            "intermediate-1"
                        ]
                    }
                ]
            },
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                    {
                        "exact_snippets": [
                            "Adult participants"
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                        "expected_value": "adult"
                    },
                    {
                        "exact_snippets": [
                            "low or intermediate-1 risk MDS"
                        ],
                        "criterion": "MDS risk",
                        "requirement_type": "category",
                        "expected_value": [
                            "low",
                            "intermediate-1"
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No previous treatment with hematopoietic growth factors within 3 months prior to screening",
                "criterions": [
                    {
                        "exact_snippets": [
                            "No previous treatment with hematopoietic growth factors"
                        ],
                        "criterion": "hematopoietic growth factors",
                        "requirement_type": "previous treatment",
                        "expected_value": false
                    },
                    {
                        "exact_snippets": [
                            "within 3 months prior to screening"
                        ],
                        "criterion": "time since last treatment with hematopoietic growth factors",
                        "requirement_type": "duration",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 3
                                }
                            ]
                        }
                    }
                ]
            },
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                                "No previous treatment with hematopoietic growth factors"
                            ],
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                            "expected_value": false
                        },
                        {
                            "exact_snippets": [
                                "within 3 months prior to screening"
                            ],
                            "criterion": "time since last treatment with hematopoietic growth factors",
                            "requirement_type": "duration",
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                                    {
                                        "operator": ">=",
                                        "value": 3
                                    }
                                ]
                            }
                        }
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                },
                "then_criteria": null,
                "else_criteria": {
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                            {
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                                    "No previous treatment with hematopoietic growth factors"
                                ],
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                                "requirement_type": "previous treatment",
                                "expected_value": false
                            },
                            {
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                                    "within 3 months prior to screening"
                                ],
                                "criterion": "time since last treatment with hematopoietic growth factors",
                                "requirement_type": "duration",
                                "expected_value": {
                                    "comparisons": [
                                        {
                                            "operator": ">=",
                                            "value": 3
                                        }
                                    ]
                                }
                            }
                        ]
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Symptomatic anemia (hemoglobin <10 g/dL) as determined by investigator",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Symptomatic anemia"
                        ],
                        "criterion": "anemia",
                        "requirement_type": "symptom presence",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "hemoglobin <10 g/dL"
                        ],
                        "criterion": "hemoglobin",
                        "requirement_type": "level",
                        "expected_value": {
                            "operator": "<",
                            "value": 10
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": [
                            "Symptomatic anemia"
                        ],
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                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "hemoglobin <10 g/dL"
                        ],
                        "criterion": "hemoglobin",
                        "requirement_type": "level",
                        "expected_value": {
                            "operator": "<",
                            "value": 10
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Serum erythropoietin <500 milliunits/milliliter (mU/mL) within 14 days prior to the first dose of study treatment",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Serum erythropoietin <500 milliunits/milliliter (mU/mL)"
                        ],
                        "criterion": "serum erythropoietin",
                        "requirement_type": "quantity",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": "<",
                                    "value": 500
                                }
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
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                            "Serum erythropoietin <500 milliunits/milliliter (mU/mL)"
                        ],
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                        "requirement_type": "quantity",
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                                {
                                    "operator": "<",
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                                }
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                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Require no red blood cell transfusion or dependent on <4 units within 8 weeks prior to screening",
                "criterions": [
                    {
                        "exact_snippets": [
                            "no red blood cell transfusion"
                        ],
                        "criterion": "red blood cell transfusion",
                        "requirement_type": "absence",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "dependent on <4 units within 8 weeks prior to screening"
                        ],
                        "criterion": "red blood cell transfusion",
                        "requirement_type": "dependency",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": "<",
                                    "value": 4
                                }
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": [
                                "no red blood cell transfusion"
                            ],
                            "criterion": "red blood cell transfusion",
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": [
                            "dependent on <4 units within 8 weeks prior to screening"
                        ],
                        "criterion": "red blood cell transfusion",
                        "requirement_type": "dependency",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": "<",
                                    "value": 4
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Clinically stable for at least 1 month prior to entry into the study",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Clinically stable for at least 1 month"
                        ],
                        "criterion": "clinical stability",
                        "requirement_type": "duration",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 1
                                }
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": [
                            "Clinically stable for at least 1 month"
                        ],
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                        "requirement_type": "duration",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 1
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* For female participants of childbearing potential and male participants with partners of childbearing potential, agreement (by participants and/or partner) to use highly effective form(s) of contraception",
                "criterions": [
                    {
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                            "female participants of childbearing potential"
                        ],
                        "criterion": "female participants",
                        "requirement_type": "childbearing potential",
                        "expected_value": true
                    },
                    {
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                            "male participants with partners of childbearing potential"
                        ],
                        "criterion": "male participants",
                        "requirement_type": "partners' childbearing potential",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "agreement (by participants and/or partner) to use highly effective form(s) of contraception"
                        ],
                        "criterion": "contraception",
                        "requirement_type": "agreement to use",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "condition": {
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                        {
                            "and_criteria": [
                                {
                                    "exact_snippets": [
                                        "female participants of childbearing potential"
                                    ],
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                                    "requirement_type": "childbearing potential",
                                    "expected_value": true
                                },
                                {
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                                        "agreement (by participants and/or partner) to use highly effective form(s) of contraception"
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                                }
                            ]
                        },
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                                        "male participants with partners of childbearing potential"
                                    ],
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                                    "requirement_type": "partners' childbearing potential",
                                    "expected_value": true
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                                {
                                    "exact_snippets": [
                                        "agreement (by participants and/or partner) to use highly effective form(s) of contraception"
                                    ],
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                                    "requirement_type": "agreement to use",
                                    "expected_value": true
                                }
                            ]
                        }
                    ]
                },
                "then_criteria": null,
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Healthy volunteers allowed"
                        ],
                        "criterion": "volunteer health status",
                        "requirement_type": "allowance",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": [
                            "Healthy volunteers allowed"
                        ],
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        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": [
                            "minimum age of 18 Years"
                        ],
                        "criterion": "age",
                        "requirement_type": "minimum",
                        "expected_value": {
                            "operator": ">=",
                            "value": 18
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
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                            "minimum age of 18 Years"
                        ],
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                        "requirement_type": "minimum",
                        "expected_value": {
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                        }
                    }
                ]
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        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Contraindications and/or known hypersensitivity to the active substance and/or any of the excipients of epoetin beta treatment",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Contraindications",
                            "to the active substance and/or any of the excipients of epoetin beta treatment"
                        ],
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                    {
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                "criterions": [
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                        "exact_snippets": [
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                        "exact_snippets": [
                            "Poorly controlled hypertension"
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                        "requirement_type": "control",
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                    }
                ]
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        },
        {
            "identified_line": {
                "line": "* History of Acute Myeloid Leukemia (AML) or high risk for AML",
                "criterions": [
                    {
                        "exact_snippets": [
                            "History of Acute Myeloid Leukemia (AML)"
                        ],
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                    },
                    {
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                        ],
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                            "History of Acute Myeloid Leukemia (AML)"
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                    },
                    {
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                        ],
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                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Administration of another investigational drug within 1 month before screening or planned during the study period",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Administration of another investigational drug"
                        ],
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                                    "value": 1
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                                "Administration of another investigational drug"
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                                "within 1 month before screening"
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                                        "value": 1
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            }
        },
        {
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                "line": "* Previously documented evidence of Pure Red Cell Aplasia (PRCA)",
                "criterions": [
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                        "exact_snippets": [
                            "Previously documented evidence of Pure Red Cell Aplasia (PRCA)"
                        ],
                        "criterion": "Pure Red Cell Aplasia (PRCA)",
                        "requirement_type": "documentation",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
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                    ],
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        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}