{
    "info": {
        "nct_id": "NCT00001748",
        "official_title": "HLA-Mismatched Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Hematological Malignancies",
        "inclusion_criteria": "Healthy volunteers allowed",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Patient:\n\nAges 10-45 years.\n\nChronic myelogenous leukemia, any of these categories: accelerated phase or blast transformation.\n\nAcute lymphoblastic leukemia, any of these categories: Adults (greater than 18 years) in any remission with high-risk features (presenting leukocyte count greater than 100,000/cu mm, Karyotypes t9; 22, t4, t19, t11, biphenotypic leukemia). All second remissions, primary induction failure including partial remission, partially responding or untreated relapse.\n\nAcute myelogenous leukemia (AML): All AML in second or subsequent remission, primary induction failure or partial remission and resistant relapse.\n\nMyelodysplastic syndromes, any of these categories: refractory anemia with excess of blasts, transformation to acute leukemia, chronic myelomonocytic leukemia.\n\nMyeloproliferative disorders undergoing transformation to terminal stages.\n\nChronic lymphocytic leukemia (CLL) in Richter transformation.\n\nHigh-grade lymphoma, refractory to standard treatment approaches, mantle cell lymphoma.\n\nNo major organ dysfunction precluding transplantation.\n\nDLCO greater than 65% predicted.\n\nLeft ventricular ejection fraction: greater than 40% predicted.\n\nECOG performance status of 0 or 1.\n\nInformed consent given. Informed consent from parents for minors.\n\nWomen of childbearing age with a negative pregnancy test may participate.\n\nDonor:\n\nPartially HLA matched family donor (3-5/6 matches).\n\nFit to receive G-CSF and give peripheral blood stem cells (normal blood count, normotensive, and no history of stroke).\n\nInformed consent given.\n\nPatients or donors must not be pregnant or nursing.\n\nMust not have ECOG performance status of 2 or more.\n\nNo severe psychiatric illness in patient or donor: Mental deficiency sufficiently severe as to make compliance with the BMT treatment unlikely and making informed consent impossible.\n\nNo major anticipated illness or organ failure incompatible with survival from BMT.\n\nDLCO must not be less than 65% predicted.\n\nNo left ventricular ejection fraction: less than 40% predicted.\n\nMust not have serum creatinine greater than 3 mg/dl.\n\nMust not have serum bilirubin greater than 4 mg/dl, Transaminases greater than 3 times the upper limit of normal.\n\nDonor or patient must not be HIV positive.\n\nMust not have history of other malignancies except basal cell or squamous carcinoma of the skin, positive PAP smear and subsequent negative follow up.\n\nDonor must be fit to receive G-CSF and undergo apheresis.\n\nMust not fail to mobilize adequate numbers of CD34+ cells after two cycles of G-CSF."
    },
    "inclusion_lines": [
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "Ages 10-45 years.",
            "criterions": [
                {
                    "exact_snippets": "Ages 10-45 years.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 10,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 45,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Chronic myelogenous leukemia, any of these categories: accelerated phase or blast transformation.",
            "criterions": [
                {
                    "exact_snippets": "Chronic myelogenous leukemia",
                    "criterion": "chronic myelogenous leukemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any of these categories: accelerated phase",
                    "criterion": "leukemia phase",
                    "requirements": [
                        {
                            "requirement_type": "category",
                            "expected_value": "accelerated phase"
                        }
                    ]
                },
                {
                    "exact_snippets": "any of these categories: ... blast transformation",
                    "criterion": "leukemia phase",
                    "requirements": [
                        {
                            "requirement_type": "category",
                            "expected_value": "blast transformation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Acute lymphoblastic leukemia, any of these categories: Adults (greater than 18 years) in any remission with high-risk features (presenting leukocyte count greater than 100,000/cu mm, Karyotypes t9; 22, t4, t19, t11, biphenotypic leukemia). All second remissions, primary induction failure including partial remission, partially responding or untreated relapse.",
            "criterions": [
                {
                    "exact_snippets": "Acute lymphoblastic leukemia",
                    "criterion": "acute lymphoblastic leukemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adults (greater than 18 years)",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "in any remission",
                    "criterion": "remission status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "any remission"
                        }
                    ]
                },
                {
                    "exact_snippets": "high-risk features",
                    "criterion": "high-risk features",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "presenting leukocyte count greater than 100,000/cu mm",
                    "criterion": "leukocyte count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "cu mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Karyotypes t9; 22, t4, t19, t11",
                    "criterion": "karyotypes",
                    "requirements": [
                        {
                            "requirement_type": "specific karyotypes",
                            "expected_value": [
                                "t9; 22",
                                "t4",
                                "t19",
                                "t11"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "biphenotypic leukemia",
                    "criterion": "biphenotypic leukemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "All second remissions",
                    "criterion": "second remission",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "all"
                        }
                    ]
                },
                {
                    "exact_snippets": "primary induction failure",
                    "criterion": "primary induction failure",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "partial remission",
                    "criterion": "partial remission",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "partially responding",
                    "criterion": "response status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "partially responding"
                        }
                    ]
                },
                {
                    "exact_snippets": "untreated relapse",
                    "criterion": "untreated relapse",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Acute myelogenous leukemia (AML): All AML in second or subsequent remission, primary induction failure or partial remission and resistant relapse.",
            "criterions": [
                {
                    "exact_snippets": "Acute myelogenous leukemia (AML)",
                    "criterion": "acute myelogenous leukemia (AML)",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "second or subsequent remission"
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "primary induction failure"
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "partial remission"
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "resistant relapse"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Myelodysplastic syndromes, any of these categories: refractory anemia with excess of blasts, transformation to acute leukemia, chronic myelomonocytic leukemia.",
            "criterions": [
                {
                    "exact_snippets": "Myelodysplastic syndromes, any of these categories: refractory anemia with excess of blasts",
                    "criterion": "myelodysplastic syndromes",
                    "requirements": [
                        {
                            "requirement_type": "categories",
                            "expected_value": [
                                "refractory anemia with excess of blasts"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Myelodysplastic syndromes, any of these categories: ... transformation to acute leukemia",
                    "criterion": "myelodysplastic syndromes",
                    "requirements": [
                        {
                            "requirement_type": "categories",
                            "expected_value": [
                                "transformation to acute leukemia"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Myelodysplastic syndromes, any of these categories: ... chronic myelomonocytic leukemia",
                    "criterion": "myelodysplastic syndromes",
                    "requirements": [
                        {
                            "requirement_type": "categories",
                            "expected_value": [
                                "chronic myelomonocytic leukemia"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Myeloproliferative disorders undergoing transformation to terminal stages.",
            "criterions": [
                {
                    "exact_snippets": "Myeloproliferative disorders undergoing transformation to terminal stages",
                    "criterion": "myeloproliferative disorders",
                    "requirements": [
                        {
                            "requirement_type": "transformation stage",
                            "expected_value": "terminal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Chronic lymphocytic leukemia (CLL) in Richter transformation.",
            "criterions": [
                {
                    "exact_snippets": "Chronic lymphocytic leukemia (CLL)",
                    "criterion": "chronic lymphocytic leukemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Richter transformation",
                    "criterion": "Richter transformation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "High-grade lymphoma, refractory to standard treatment approaches, mantle cell lymphoma.",
            "criterions": [
                {
                    "exact_snippets": "High-grade lymphoma",
                    "criterion": "lymphoma",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": "high"
                        }
                    ]
                },
                {
                    "exact_snippets": "refractory to standard treatment approaches",
                    "criterion": "treatment response",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "refractory"
                        }
                    ]
                },
                {
                    "exact_snippets": "mantle cell lymphoma",
                    "criterion": "lymphoma subtype",
                    "requirements": [
                        {
                            "requirement_type": "subtype",
                            "expected_value": "mantle cell"
                        }
                    ]
                }
            ]
        },
        {
            "line": "No major organ dysfunction precluding transplantation.",
            "criterions": [
                {
                    "exact_snippets": "No major organ dysfunction",
                    "criterion": "major organ dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "precluding transplantation",
                    "criterion": "transplantation",
                    "requirements": [
                        {
                            "requirement_type": "preclusion",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "DLCO greater than 65% predicted.",
            "criterions": [
                {
                    "exact_snippets": "DLCO greater than 65% predicted",
                    "criterion": "DLCO",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 65,
                                "unit": "% predicted"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Left ventricular ejection fraction: greater than 40% predicted.",
            "criterions": [
                {
                    "exact_snippets": "Left ventricular ejection fraction: greater than 40%",
                    "criterion": "left ventricular ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 40,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "ECOG performance status of 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status of 0 or 1.",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Informed consent given. Informed consent from parents for minors.",
            "criterions": [
                {
                    "exact_snippets": "Informed consent given.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Informed consent from parents for minors.",
                    "criterion": "informed consent from parents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Women of childbearing age with a negative pregnancy test may participate.",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing age",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive status",
                            "expected_value": "childbearing age"
                        }
                    ]
                },
                {
                    "exact_snippets": "negative pregnancy test",
                    "criterion": "pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Donor:",
            "criterions": [
                {
                    "exact_snippets": "Donor",
                    "criterion": "donor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Partially HLA matched family donor (3-5/6 matches).",
            "criterions": [
                {
                    "exact_snippets": "Partially HLA matched family donor (3-5/6 matches)",
                    "criterion": "HLA match with family donor",
                    "requirements": [
                        {
                            "requirement_type": "match level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "matches"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "matches"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Fit to receive G-CSF and give peripheral blood stem cells (normal blood count, normotensive, and no history of stroke).",
            "criterions": [
                {
                    "exact_snippets": "Fit to receive G-CSF",
                    "criterion": "G-CSF administration",
                    "requirements": [
                        {
                            "requirement_type": "fitness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "give peripheral blood stem cells",
                    "criterion": "peripheral blood stem cell donation",
                    "requirements": [
                        {
                            "requirement_type": "fitness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "normal blood count",
                    "criterion": "blood count",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "normotensive",
                    "criterion": "blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normotensive"
                        }
                    ]
                },
                {
                    "exact_snippets": "no history of stroke",
                    "criterion": "history of stroke",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Informed consent given.",
            "criterions": [
                {
                    "exact_snippets": "Informed consent given",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "given",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Patients or donors must not be pregnant or nursing.",
            "criterions": [
                {
                    "exact_snippets": "Patients or donors must not be pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients or donors must not be ... nursing",
                    "criterion": "nursing status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must not have ECOG performance status of 2 or more.",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status of 2 or more",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "No severe psychiatric illness in patient or donor: Mental deficiency sufficiently severe as to make compliance with the BMT treatment unlikely and making informed consent impossible.",
            "criterions": [
                {
                    "exact_snippets": "No severe psychiatric illness in patient",
                    "criterion": "psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "No severe psychiatric illness in ... donor",
                    "criterion": "psychiatric illness in donor",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "Mental deficiency sufficiently severe as to make compliance with the BMT treatment unlikely",
                    "criterion": "mental deficiency",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "sufficiently severe to make compliance with the BMT treatment unlikely"
                        }
                    ]
                },
                {
                    "exact_snippets": "Mental deficiency ... making informed consent impossible",
                    "criterion": "mental deficiency",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "making informed consent impossible"
                        }
                    ]
                }
            ]
        },
        {
            "line": "No major anticipated illness or organ failure incompatible with survival from BMT.",
            "criterions": [
                {
                    "exact_snippets": "No major anticipated illness",
                    "criterion": "major anticipated illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... organ failure incompatible with survival from BMT",
                    "criterion": "organ failure incompatible with survival from BMT",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "DLCO must not be less than 65% predicted.",
            "criterions": [
                {
                    "exact_snippets": "DLCO must not be less than 65% predicted.",
                    "criterion": "DLCO",
                    "requirements": [
                        {
                            "requirement_type": "predicted percentage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 65,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "No left ventricular ejection fraction: less than 40% predicted.",
            "criterions": [
                {
                    "exact_snippets": "No left ventricular ejection fraction: less than 40%",
                    "criterion": "left ventricular ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 40,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must not have serum creatinine greater than 3 mg/dl.",
            "criterions": [
                {
                    "exact_snippets": "serum creatinine greater than 3 mg/dl",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "mg/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must not have serum bilirubin greater than 4 mg/dl, Transaminases greater than 3 times the upper limit of normal.",
            "criterions": [
                {
                    "exact_snippets": "serum bilirubin greater than 4 mg/dl",
                    "criterion": "serum bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "mg/dl"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Transaminases greater than 3 times the upper limit of normal",
                    "criterion": "Transaminases",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Donor or patient must not be HIV positive.",
            "criterions": [
                {
                    "exact_snippets": "Donor or patient must not be HIV positive.",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must not have history of other malignancies except basal cell or squamous carcinoma of the skin, positive PAP smear and subsequent negative follow up.",
            "criterions": [
                {
                    "exact_snippets": "Must not have history of other malignancies",
                    "criterion": "history of other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except basal cell or squamous carcinoma of the skin",
                    "criterion": "basal cell or squamous carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "positive PAP smear",
                    "criterion": "positive PAP smear",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "subsequent negative follow up",
                    "criterion": "negative follow up after positive PAP smear",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Donor must be fit to receive G-CSF and undergo apheresis.",
            "criterions": [
                {
                    "exact_snippets": "Donor must be fit to receive G-CSF",
                    "criterion": "fitness to receive G-CSF",
                    "requirements": [
                        {
                            "requirement_type": "fitness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Donor must be fit to ... undergo apheresis",
                    "criterion": "fitness to undergo apheresis",
                    "requirements": [
                        {
                            "requirement_type": "fitness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must not fail to mobilize adequate numbers of CD34+ cells after two cycles of G-CSF.",
            "criterions": [
                {
                    "exact_snippets": "Must not fail to mobilize adequate numbers of CD34+ cells",
                    "criterion": "CD34+ cell mobilization",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "after two cycles of G-CSF",
                    "criterion": "G-CSF cycles",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "cycles"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Patient:",
            "criterions": []
        }
    ]
}