{
    "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": [
        {
            "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"
                    ]
                }
            ]
        },
        {
            "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
                            }
                        ]
                    }
                }
            ]
        },
        {
            "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
                    }
                }
            ]
        },
        {
            "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
                            }
                        ]
                    }
                }
            ]
        },
        {
            "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
                            }
                        ]
                    }
                }
            ]
        },
        {
            "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
                            }
                        ]
                    }
                }
            ]
        },
        {
            "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": [
                {
                    "exact_snippets": [
                        "female participants of childbearing potential"
                    ],
                    "criterion": "female participants",
                    "requirement_type": "childbearing potential",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "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
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "volunteer health status",
                    "requirement_type": "allowance",
                    "expected_value": true
                }
            ]
        },
        {
            "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
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "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"
                    ],
                    "criterion": "contraindications",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "known hypersensitivity",
                        "to the active substance and/or any of the excipients of epoetin beta treatment"
                    ],
                    "criterion": "hypersensitivity",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Poorly controlled hypertension as assessed by the investigator",
            "criterions": [
                {
                    "exact_snippets": [
                        "Poorly controlled hypertension"
                    ],
                    "criterion": "hypertension",
                    "requirement_type": "control",
                    "expected_value": "poorly controlled"
                }
            ]
        },
        {
            "line": "* History of Acute Myeloid Leukemia (AML) or high risk for AML",
            "criterions": [
                {
                    "exact_snippets": [
                        "History of Acute Myeloid Leukemia (AML)"
                    ],
                    "criterion": "Acute Myeloid Leukemia (AML)",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "high risk for AML"
                    ],
                    "criterion": "Acute Myeloid Leukemia (AML)",
                    "requirement_type": "risk",
                    "expected_value": "high"
                }
            ]
        },
        {
            "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"
                    ],
                    "criterion": "investigational drug",
                    "requirement_type": "administration",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "within 1 month before screening"
                    ],
                    "criterion": "investigational drug administration",
                    "requirement_type": "timeframe",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 1
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Previously documented evidence of Pure Red Cell Aplasia (PRCA)",
            "criterions": [
                {
                    "exact_snippets": [
                        "Previously documented evidence of Pure Red Cell Aplasia (PRCA)"
                    ],
                    "criterion": "Pure Red Cell Aplasia (PRCA)",
                    "requirement_type": "documentation",
                    "expected_value": true
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}