{
    "info": {
        "nct_id": "NCT00272662",
        "official_title": "A Phase 2, Open-Label, Multi-Center Dose Escalation Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Subcutaneously Administered Peginesatide in Anemic Cancer Patients Receiving Chemotherapy",
        "inclusion_criteria": "* Participant is informed of the investigational nature of this study and has given written, witnessed informed consent in accordance with institutional, local, and national guidelines\n* Males or females ≥ 18 and ≤ 80 years of age; pre-menopausal females (with the exception of those who are surgically sterile) must have a negative pregnancy test at screening; those who are sexually active must practice a highly effective method of birth control for at least 2 weeks prior to study start, and must be willing to continue practicing birth control for at least 4 weeks after the last dose of study drug. A highly effective method of birth control is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence (only acceptable if practiced as a life-style and not acceptable if one who is sexually active practices abstinence only for the duration of study) or vasectomized partner\n* Participants with histologically confirmed solid tumor malignancy or lymphoma who are scheduled to receive at least 9 weeks of cyclic myelosuppressive chemotherapy while on study\n* Hemoglobin value of ≥ 8 and < 11 g/dL within 1 week prior to administration of study drug.\n* ECOG Performance Status of 0-2\n* One reticulocyte hemoglobin content (CHr) > 29 picograms within 4 weeks prior to study drug administration.\n* One transferrin saturation ≥ 15% within 4 weeks prior to study drug administration.\n* One serum or red cell folate level above the lower limit of normal within 4 weeks prior to study drug administration\n* One vitamin B12 level above the lower limit of normal within 4 weeks prior to study drug administration\n* One absolute neutrophil count ≥ 1.0 x 10^9/L within 1 week prior to administration of study drug\n* One platelet count ≥ 75 x 10^9/L within 1 week prior to administration of study drug\n* Life expectancy > 6 months.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "* Treatment with any erythropoiesis stimulating agent (ESA) in the past 90 days\n* History of failure to respond to ESA treatment\n* Known antibodies to other ESAs or history of pure red cell aplasia (PRCA)\n* Acute or chronic leukemia, myelodysplastic syndrome (MDS), or multiple myeloma\n* Any previous or planned radiotherapy to more than 50% of either the pelvis or spine\n* Known intolerance to parenteral iron supplementation\n* Red blood cell transfusion within 4 weeks prior to study drug administration\n* Known hemoglobinopathy (e.g., homozygous sickle-cell disease, thalassemia of all types, etc.)\n* Known hemolysis\n* History of pulmonary embolism or deep venous thrombosis (DVT) in the previous 2 years or current therapeutic doses of anticoagulants\n* Known blood loss as a cause of anemia\n* Uncontrolled, or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.)\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times the upper limit of normal; AST or ALT > 5 times the upper limit of normal if liver metastases are present.\n* Creatinine > 175 micromoles per liter (µmol/L)\n* History of bone marrow or peripheral blood cell transplantation\n* Pyrexia/fever of ≥ 39 °C within 48 hours prior to study drug administration\n* Poorly controlled hypertension, per the Investigator's judgment, within 4 weeks prior to study drug administration (e.g., systolic ≥ 170 mm Hg or diastolic ≥ 100 mm Hg on repeat readings)\n* Epileptic seizure in the 6 months prior to study drug administration\n* Advanced chronic congestive heart failure - New York Heart Association Class IV\n* High likelihood of early withdrawal or interruption of the study\n* Anticipated elective surgery during the study period\n* History of multiple drug allergies\n* Exposure to any investigational agent within 1 month prior to administration of study drug or planned receipt during the study period.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Participant is informed of the investigational nature of this study and has given written, witnessed informed consent in accordance with institutional, local, and national guidelines",
            "criterions": [
                {
                    "exact_snippets": "Participant is informed of the investigational nature of this study",
                    "criterion": "informed of investigational nature",
                    "requirements": [
                        {
                            "requirement_type": "awareness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "has given written, witnessed informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "form",
                            "expected_value": "written, witnessed"
                        }
                    ]
                },
                {
                    "exact_snippets": "in accordance with institutional, local, and national guidelines",
                    "criterion": "guidelines compliance",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": [
                                "institutional",
                                "local",
                                "national"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Males or females ≥ 18 and ≤ 80 years of age; pre-menopausal females (with the exception of those who are surgically sterile) must have a negative pregnancy test at screening; those who are sexually active must practice a highly effective method of birth control for at least 2 weeks prior to study start, and must be willing to continue practicing birth control for at least 4 weeks after the last dose of study drug. A highly effective method of birth control is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence (only acceptable if practiced as a life-style and not acceptable if one who is sexually active practices abstinence only for the duration of study) or vasectomized partner",
            "criterions": [
                {
                    "exact_snippets": "Males or females",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "≥ 18 and ≤ 80 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 80,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "pre-menopausal females (with the exception of those who are surgically sterile) must have a negative pregnancy test at screening",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "those who are sexually active must practice a highly effective method of birth control for at least 2 weeks prior to study start",
                    "criterion": "birth control method",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "at least 2 weeks prior to study start"
                        }
                    ]
                },
                {
                    "exact_snippets": "must be willing to continue practicing birth control for at least 4 weeks after the last dose of study drug",
                    "criterion": "birth control method",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "at least 4 weeks after the last dose of study drug"
                        }
                    ]
                },
                {
                    "exact_snippets": "A highly effective method of birth control is defined as one that results in a low failure rate (i.e., less than 1% per year)",
                    "criterion": "birth control method effectiveness",
                    "requirements": [
                        {
                            "requirement_type": "failure rate",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "% per year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with histologically confirmed solid tumor malignancy or lymphoma who are scheduled to receive at least 9 weeks of cyclic myelosuppressive chemotherapy while on study",
            "criterions": [
                {
                    "exact_snippets": "histologically confirmed solid tumor malignancy or lymphoma",
                    "criterion": "solid tumor malignancy or lymphoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "scheduled to receive at least 9 weeks of cyclic myelosuppressive chemotherapy",
                    "criterion": "cyclic myelosuppressive chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin value of ≥ 8 and < 11 g/dL within 1 week prior to administration of study drug.",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin value of ≥ 8 and < 11 g/dL",
                    "criterion": "hemoglobin value",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 8,
                                        "unit": "g/dL"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 11,
                                        "unit": "g/dL"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "within 1 week prior to administration of study drug",
                    "criterion": "timeframe for hemoglobin test",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 1 week prior to administration of study drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG Performance Status of 0-2",
            "criterions": [
                {
                    "exact_snippets": "ECOG Performance Status of 0-2",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* One reticulocyte hemoglobin content (CHr) > 29 picograms within 4 weeks prior to study drug administration.",
            "criterions": [
                {
                    "exact_snippets": "reticulocyte hemoglobin content (CHr) > 29 picograms",
                    "criterion": "reticulocyte hemoglobin content (CHr)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 29,
                                "unit": "picograms"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* One transferrin saturation ≥ 15% within 4 weeks prior to study drug administration.",
            "criterions": [
                {
                    "exact_snippets": "transferrin saturation ≥ 15%",
                    "criterion": "transferrin saturation",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* One serum or red cell folate level above the lower limit of normal within 4 weeks prior to study drug administration",
            "criterions": [
                {
                    "exact_snippets": "One serum or red cell folate level above the lower limit of normal within 4 weeks prior to study drug administration",
                    "criterion": "serum or red cell folate level",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 0,
                                "unit": "lower limit of normal"
                            }
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 4 weeks prior to study drug administration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* One vitamin B12 level above the lower limit of normal within 4 weeks prior to study drug administration",
            "criterions": [
                {
                    "exact_snippets": "vitamin B12 level above the lower limit of normal",
                    "criterion": "vitamin B12 level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": "> lower limit of normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 4 weeks prior to study drug administration",
                    "criterion": "timeframe for vitamin B12 level test",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 4 weeks prior to study drug administration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* One absolute neutrophil count ≥ 1.0 x 10^9/L within 1 week prior to administration of study drug",
            "criterions": [
                {
                    "exact_snippets": "absolute neutrophil count ≥ 1.0 x 10^9/L",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.0,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* One platelet count ≥ 75 x 10^9/L within 1 week prior to administration of study drug",
            "criterions": [
                {
                    "exact_snippets": "platelet count ≥ 75 x 10^9/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 75,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "within 1 week prior to administration of study drug",
                    "criterion": "timeframe for platelet count measurement",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 1 week prior to administration of study drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy > 6 months.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy > 6 months.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 80 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 80 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Treatment with any erythropoiesis stimulating agent (ESA) in the past 90 days",
            "criterions": [
                {
                    "exact_snippets": "Treatment with any erythropoiesis stimulating agent (ESA) in the past 90 days",
                    "criterion": "erythropoiesis stimulating agent (ESA) treatment",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 90,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of failure to respond to ESA treatment",
            "criterions": [
                {
                    "exact_snippets": "History of failure to respond to ESA treatment",
                    "criterion": "ESA treatment response",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "failure"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known antibodies to other ESAs or history of pure red cell aplasia (PRCA)",
            "criterions": [
                {
                    "exact_snippets": "Known antibodies to other ESAs",
                    "criterion": "antibodies to ESAs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of pure red cell aplasia (PRCA)",
                    "criterion": "pure red cell aplasia (PRCA)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Acute or chronic leukemia, myelodysplastic syndrome (MDS), or multiple myeloma",
            "criterions": [
                {
                    "exact_snippets": "Acute or chronic leukemia",
                    "criterion": "leukemia",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "acute",
                                "chronic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "myelodysplastic syndrome (MDS)",
                    "criterion": "myelodysplastic syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "multiple myeloma",
                    "criterion": "multiple myeloma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any previous or planned radiotherapy to more than 50% of either the pelvis or spine",
            "criterions": [
                {
                    "exact_snippets": "previous or planned radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": [
                                "previous",
                                "planned"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "more than 50% of either the pelvis",
                    "criterion": "pelvis radiotherapy coverage",
                    "requirements": [
                        {
                            "requirement_type": "coverage",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "more than 50% of ... spine",
                    "criterion": "spine radiotherapy coverage",
                    "requirements": [
                        {
                            "requirement_type": "coverage",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known intolerance to parenteral iron supplementation",
            "criterions": [
                {
                    "exact_snippets": "Known intolerance to parenteral iron supplementation",
                    "criterion": "intolerance to parenteral iron supplementation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Red blood cell transfusion within 4 weeks prior to study drug administration",
            "criterions": [
                {
                    "exact_snippets": "Red blood cell transfusion within 4 weeks prior to study drug administration",
                    "criterion": "red blood cell transfusion",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known hemoglobinopathy (e.g., homozygous sickle-cell disease, thalassemia of all types, etc.)",
            "criterions": [
                {
                    "exact_snippets": "Known hemoglobinopathy (e.g., homozygous sickle-cell disease, thalassemia of all types, etc.)",
                    "criterion": "hemoglobinopathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known hemolysis",
            "criterions": [
                {
                    "exact_snippets": "Known hemolysis",
                    "criterion": "hemolysis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of pulmonary embolism or deep venous thrombosis (DVT) in the previous 2 years or current therapeutic doses of anticoagulants",
            "criterions": [
                {
                    "exact_snippets": "History of pulmonary embolism",
                    "criterion": "pulmonary embolism",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... deep venous thrombosis (DVT)",
                    "criterion": "deep venous thrombosis (DVT)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "current therapeutic doses of anticoagulants",
                    "criterion": "therapeutic doses of anticoagulants",
                    "requirements": [
                        {
                            "requirement_type": "current use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known blood loss as a cause of anemia",
            "criterions": [
                {
                    "exact_snippets": "Known blood loss as a cause of anemia",
                    "criterion": "blood loss",
                    "requirements": [
                        {
                            "requirement_type": "cause of anemia",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled, or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.)",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled, or symptomatic inflammatory disease",
                    "criterion": "inflammatory disease",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "symptom presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "rheumatoid arthritis",
                    "criterion": "rheumatoid arthritis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "systemic lupus erythematosus",
                    "criterion": "systemic lupus erythematosus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times the upper limit of normal; AST or ALT > 5 times the upper limit of normal if liver metastases are present.",
            "criterions": [
                {
                    "exact_snippets": "Aspartate aminotransferase (AST) ... > 2.5 times the upper limit of normal",
                    "criterion": "Aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.5,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine aminotransferase (ALT) ... > 2.5 times the upper limit of normal",
                    "criterion": "alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.5,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST ... > 5 times the upper limit of normal if liver metastases are present",
                    "criterion": "Aspartate aminotransferase (AST) with liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT ... > 5 times the upper limit of normal if liver metastases are present",
                    "criterion": "alanine aminotransferase (ALT) with liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine > 175 micromoles per liter (µmol/L)",
            "criterions": [
                {
                    "exact_snippets": "Creatinine > 175 micromoles per liter (µmol/L)",
                    "criterion": "creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 175,
                                "unit": "micromoles per liter (µmol/L)"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of bone marrow or peripheral blood cell transplantation",
            "criterions": [
                {
                    "exact_snippets": "History of bone marrow or peripheral blood cell transplantation",
                    "criterion": "bone marrow transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of bone marrow or peripheral blood cell transplantation",
                    "criterion": "peripheral blood cell transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pyrexia/fever of ≥ 39 °C within 48 hours prior to study drug administration",
            "criterions": [
                {
                    "exact_snippets": "Pyrexia/fever of ≥ 39 °C",
                    "criterion": "pyrexia/fever",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 39,
                                "unit": "°C"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "within 48 hours prior to study drug administration",
                    "criterion": "time since fever",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 48,
                                "unit": "hours"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Poorly controlled hypertension, per the Investigator's judgment, within 4 weeks prior to study drug administration (e.g., systolic ≥ 170 mm Hg or diastolic ≥ 100 mm Hg on repeat readings)",
            "criterions": [
                {
                    "exact_snippets": "Poorly controlled hypertension, per the Investigator's judgment",
                    "criterion": "hypertension control",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "poorly controlled"
                        }
                    ]
                },
                {
                    "exact_snippets": "systolic ≥ 170 mm Hg",
                    "criterion": "systolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 170,
                                "unit": "mm Hg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "diastolic ≥ 100 mm Hg",
                    "criterion": "diastolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "mm Hg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Epileptic seizure in the 6 months prior to study drug administration",
            "criterions": [
                {
                    "exact_snippets": "Epileptic seizure in the 6 months prior to study drug administration",
                    "criterion": "epileptic seizure",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "6 months prior to study drug administration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Advanced chronic congestive heart failure - New York Heart Association Class IV",
            "criterions": [
                {
                    "exact_snippets": "Advanced chronic congestive heart failure",
                    "criterion": "chronic congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "advanced"
                        }
                    ]
                },
                {
                    "exact_snippets": "New York Heart Association Class IV",
                    "criterion": "New York Heart Association class",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": "Class IV"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* High likelihood of early withdrawal or interruption of the study",
            "criterions": [
                {
                    "exact_snippets": "High likelihood of early withdrawal or interruption of the study",
                    "criterion": "likelihood of early withdrawal or interruption",
                    "requirements": [
                        {
                            "requirement_type": "likelihood",
                            "expected_value": "high"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Anticipated elective surgery during the study period",
            "criterions": [
                {
                    "exact_snippets": "Anticipated elective surgery during the study period",
                    "criterion": "elective surgery",
                    "requirements": [
                        {
                            "requirement_type": "anticipated",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "during the study period"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of multiple drug allergies",
            "criterions": [
                {
                    "exact_snippets": "History of multiple drug allergies",
                    "criterion": "drug allergies",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": "multiple"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Exposure to any investigational agent within 1 month prior to administration of study drug or planned receipt during the study period.",
            "criterions": [
                {
                    "exact_snippets": "Exposure to any investigational agent within 1 month prior to administration of study drug",
                    "criterion": "exposure to investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "planned receipt during the study period",
                    "criterion": "planned receipt of investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "during the study period"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}