{
    "info": {
        "nct_id": "NCT05455294",
        "official_title": "A Phase 1 Study of Triplet Therapy with Navitoclax, Venetoclax, and Decitabine for High-risk Myeloid Malignancies",
        "inclusion_criteria": "* 18 years or older\n* Subjects must have a diagnosis of one of the following:\n\n  * Myelofibrosis in accelerated phase (AP-MF), defined by WHO as 10-19% blasts in either bone marrow or blood. There is no requirement for prior therapy.\n  * Myelofibrosis in blast phase (BP-MF), defined as ≥ 20% blasts in either bone marrow or blood. There is no requirement for prior therapy.\n  * Untreated secondary AML (s-AML), which includes subjects with therapy-related disease or known antecedent MDS or MDS/MPN. All these subjects must be ineligible or not recommended for any available approved therapy as determined by the treating provider. For subjects with known antecedent MDS or MDS/MPN, they must have received prior HMA therapy (minimum number of cycles are not required in this setting).\n  * MDS/MPN overlap syndromes (e.g. CMML) with ≥ 5% blasts in either bone marrow or blood. No requirements for prior therapy.\n  * MDS with excess blasts defined as ≥ 5% blasts in either bone marrow or blood must be ineligible for any available approved therapy including intensive chemotherapy and immediate allogeneic stem cell transplant per treating investigator and must meet at least one of the following criteria: 1) persistent disease despite prior exposure to venetoclax plus HMA for at least 3 cycles, 2) disease progression per IWG 2006 criteria on venetoclax plus HMA or on M15-954 protocol, or 3) persistent disease after at least four cycles of any HMA-based therapy.\n* ECOG performance status ≤ 2 (see Appendix A)\n* Baseline platelet count ≥ 25 x 109/L\n* Subjects must have adequate organ function as defined below:\n\n  * Aspartate transaminase (AST) and alanine transaminase (ALT) < 3 x ULN\n  * Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)\n  * Subject must have adequate renal function as demonstrated by a creatinine clearance ≥ 45 mL/min; calculated by the Cockcroft Gault formula\n  * aPTT ≤ 1.5 x ULN\n  * INR ≤ 1.5 x ULN\n* Prior treatment-related toxicities must be grade 1 or baseline except for alopecia.\n* Moderate/strong inhibitors of CYP3A are allowed if they cannot be substituted; however, patients must be on these agents for at least 2-3 days prior to treatment start. (See section 5.5 for details on concomitant medications and dose adjustment.)\n* If female, subject must be either :\n\n  * Postmenopausal (surgically sterile or age > 55 years with no menses for 12 or more months without an alternative medical cause or age greater than or equal to 55 or less with no menses for 12 or more months without an alternative medical cause and an FSH level > 40 IU/L); or\n  * Of children bearing potential. These subjects must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Subject must agree to have a negative urine or serum beta-HCG test result during screening and repeated within 7 days prior to study drug (local labs are allowed) to be eligible.\n* Subject must voluntarily sign and date an informed consent\n* Subjects must be able to swallow pills\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Subject cannot have had prior navitoclax or any BCL-XL therapy. Otherwise, there are no restrictions on any other prior therapies. Prior venetoclax is allowed.\n* Subject is eligible and willing to receive intensive chemotherapy for their specific disease.\n* Anti-leukemic therapy within 14 days of first day of study treatment except for hydroxyurea. If on hydroxyurea, then subject needs to be off hydroxyurea at least 3 days prior to first dose of study treatment. If on venetoclax, then a wash-out period of at least five times the half-life of the treatment.\n* Subject with known and active concurrent malignancy requiring treatment. Subjects with basal or squamous skin cancers or carcinomas in situ are allowed. Exception: hormonal or topical therapies are allowed.\n* Subject has known active/uncontrolled HIV and on contraindicated medication due to drug-drug CYP inducer interaction. HIV testing is not required.\n* Subject has known and active CNS involvement with AML.\n* Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:\n\n  * Uncontrolled and/or active systemic infection (viral, bacterial or fungal). Controlled infections are allowed.\n  * Chronic, active hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate. Subjects that have prior HCV that has been definitively treated with negative HCV viral load prior to study initiation and no evidence of cirrhosis are allowed to participate.\n* Recent diagnosis of myocardial infarction or worse heart failure within the last six months.\n* Treatment with any moderate or strong CYP3A inducers (see Appendix D for examples) within 7 days prior to the first dose of study drug.\n* Administration or consumption of any of the following within 3 days prior to the first dose of study drug:\n\n  * Grapefruit or grapefruit products\n  * Seville oranges (including marmalade containing Seville oranges)\n  * Star fruit\n* White blood cell count (WBC) greater than or equal to 25 x 109/L. Exception: Subjects with myelofibrosis or MDS/MPN overlap syndrome may enter study with WBC greater than or equal 25 x 109/L on the first day of therapy only if the absolute blast count is < 5 x 109/L; hospitalization for subjects with this particular disease subset is required during dose ramp-up of venetoclax for TLS monitoring. This criterion is intended to exclude AML patients at high risk of TLS, but permit entry of patients with MF or CMML who frequently have leukocytosis without AML transformation who are at low risk for TLS.\n* Ongoing requirement for anticoagulation with the exception of low-dose anticoagulation medications used to maintain patency of a central venous catheter or for deep venous thrombosis prophylaxis. Antiplatelet agents such as aspirin and clopidogrel are not allowed if platelet count < 50 x 109/L.\n* Known history of immune thrombocytopenia that previously required therapy.\n* Known history of platelet refractoriness and HLA alloimmunization prior to study start.\n* History of serious or life-threatening bleeding in last 12 months that has not been definitively treated.\n* Uncontrolled, systemic infection (viral, bacterial, or fungal). Antibiotic use is permitted. (See Section 5.5 for concomitant drugs)\n* Active and known SARS-CoV-2 infection.\n\n  * If a subject has signs/symptoms suggestive of SARS-CoV-2 infection, then the subject must undergo molecular (e.g. PCR) testing to rule out SARS-CoV-2 infection.\n  * Subjects positive for active SARS-CoV-2 infection may re-screen after they meet either criteria A or B indicating SARS-CoV-2 infection has resolved with viral clearance: A) ≥14 days since first the PCR test result in an asymptomatic subject; OR B) ≥14 days since recovery, defined as resolution of fever without use of anti-pyretics and improvement in symptoms.\n* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and/or would make the subject inappropriate for enrollment into this study.\n* Vaccination with live, attenuated vaccines ≤4 weeks prior to initiation of study treatment or anticipation of need for such a vaccine during the study. All other recommended vaccinations including COVID19 is permitted.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* 18 years or older",
            "criterions": [
                {
                    "exact_snippets": "18 years or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects must have a diagnosis of one of the following:",
            "criterions": [
                {
                    "exact_snippets": "diagnosis of one of the following",
                    "criterion": "diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Myelofibrosis in accelerated phase (AP-MF), defined by WHO as 10-19% blasts in either bone marrow or blood. There is no requirement for prior therapy.",
            "criterions": [
                {
                    "exact_snippets": "Myelofibrosis in accelerated phase (AP-MF)",
                    "criterion": "myelofibrosis",
                    "requirements": [
                        {
                            "requirement_type": "phase",
                            "expected_value": "accelerated"
                        }
                    ]
                },
                {
                    "exact_snippets": "10-19% blasts in either bone marrow or blood",
                    "criterion": "blasts percentage",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 10,
                                        "unit": "%"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 19,
                                        "unit": "%"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "There is no requirement for prior therapy",
                    "criterion": "prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Myelofibrosis in blast phase (BP-MF), defined as ≥ 20% blasts in either bone marrow or blood. There is no requirement for prior therapy.",
            "criterions": [
                {
                    "exact_snippets": "Myelofibrosis in blast phase (BP-MF)",
                    "criterion": "myelofibrosis in blast phase",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "≥ 20% blasts in either bone marrow or blood",
                    "criterion": "blasts percentage",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "There is no requirement for prior therapy",
                    "criterion": "prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Untreated secondary AML (s-AML), which includes subjects with therapy-related disease or known antecedent MDS or MDS/MPN. All these subjects must be ineligible or not recommended for any available approved therapy as determined by the treating provider. For subjects with known antecedent MDS or MDS/MPN, they must have received prior HMA therapy (minimum number of cycles are not required in this setting).",
            "criterions": [
                {
                    "exact_snippets": "Untreated secondary AML (s-AML)",
                    "criterion": "secondary AML (s-AML)",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "therapy-related disease",
                    "criterion": "therapy-related disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known antecedent MDS",
                    "criterion": "antecedent MDS",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known antecedent ... MDS/MPN",
                    "criterion": "antecedent MDS/MPN",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ineligible or not recommended for any available approved therapy",
                    "criterion": "eligibility for approved therapy",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "received prior HMA therapy",
                    "criterion": "prior HMA therapy",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* MDS/MPN overlap syndromes (e.g. CMML) with ≥ 5% blasts in either bone marrow or blood. No requirements for prior therapy.",
            "criterions": [
                {
                    "exact_snippets": "MDS/MPN overlap syndromes",
                    "criterion": "MDS/MPN overlap syndromes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "≥ 5% blasts in either bone marrow or blood",
                    "criterion": "blasts in bone marrow or blood",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No requirements for prior therapy",
                    "criterion": "prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* MDS with excess blasts defined as ≥ 5% blasts in either bone marrow or blood must be ineligible for any available approved therapy including intensive chemotherapy and immediate allogeneic stem cell transplant per treating investigator and must meet at least one of the following criteria: 1) persistent disease despite prior exposure to venetoclax plus HMA for at least 3 cycles, 2) disease progression per IWG 2006 criteria on venetoclax plus HMA or on M15-954 protocol, or 3) persistent disease after at least four cycles of any HMA-based therapy.",
            "criterions": [
                {
                    "exact_snippets": "MDS with excess blasts defined as ≥ 5% blasts in either bone marrow or blood",
                    "criterion": "MDS with excess blasts",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 5,
                                        "unit": "%"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "must be ineligible for any available approved therapy including intensive chemotherapy and immediate allogeneic stem cell transplant per treating investigator",
                    "criterion": "ineligibility for approved therapy",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "must meet at least one of the following criteria: 1) persistent disease despite prior exposure to venetoclax plus HMA for at least 3 cycles",
                    "criterion": "persistent disease despite prior exposure to venetoclax plus HMA",
                    "requirements": [
                        {
                            "requirement_type": "treatment duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "cycles"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "must meet at least one of the following criteria: ... 2) disease progression per IWG 2006 criteria on venetoclax plus HMA or on M15-954 protocol",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "progression criteria",
                            "expected_value": "IWG 2006 criteria"
                        }
                    ]
                },
                {
                    "exact_snippets": "must meet at least one of the following criteria: ... 3) persistent disease after at least four cycles of any HMA-based therapy",
                    "criterion": "persistent disease after HMA-based therapy",
                    "requirements": [
                        {
                            "requirement_type": "treatment duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "cycles"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status ≤ 2 (see Appendix A)",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status ≤ 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Baseline platelet count ≥ 25 x 109/L",
            "criterions": [
                {
                    "exact_snippets": "Baseline platelet count ≥ 25 x 109/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "baseline",
                            "expected_value": {
                                "operator": ">=",
                                "value": 25,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects must have adequate organ function as defined below:",
            "criterions": [
                {
                    "exact_snippets": "adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin ≤1.5 x ULN",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unless bilirubin rise is due to Gilbert's syndrome",
                    "criterion": "bilirubin rise due to Gilbert's syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unless bilirubin rise is ... of non-hepatic origin",
                    "criterion": "bilirubin rise of non-hepatic origin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject must have adequate renal function as demonstrated by a creatinine clearance ≥ 45 mL/min; calculated by the Cockcroft Gault formula",
            "criterions": [
                {
                    "exact_snippets": "adequate renal function as demonstrated by a creatinine clearance ≥ 45 mL/min",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "creatinine clearance",
                            "expected_value": {
                                "operator": ">=",
                                "value": 45,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* aPTT ≤ 1.5 x ULN",
            "criterions": [
                {
                    "exact_snippets": "aPTT ≤ 1.5 x ULN",
                    "criterion": "aPTT",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* INR ≤ 1.5 x ULN",
            "criterions": [
                {
                    "exact_snippets": "INR ≤ 1.5 x ULN",
                    "criterion": "INR",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment-related toxicities must be grade 1 or baseline except for alopecia.",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment-related toxicities must be grade 1 or baseline",
                    "criterion": "prior treatment-related toxicities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "grade 1",
                                "baseline"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "except for alopecia",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Moderate/strong inhibitors of CYP3A are allowed if they cannot be substituted; however, patients must be on these agents for at least 2-3 days prior to treatment start. (See section 5.5 for details on concomitant medications and dose adjustment.)",
            "criterions": [
                {
                    "exact_snippets": "Moderate/strong inhibitors of CYP3A are allowed if they cannot be substituted",
                    "criterion": "CYP3A inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "substitution",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "patients must be on these agents for at least 2-3 days prior to treatment start",
                    "criterion": "CYP3A inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "days"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If female, subject must be either :",
            "criterions": [
                {
                    "exact_snippets": "If female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Postmenopausal (surgically sterile or age > 55 years with no menses for 12 or more months without an alternative medical cause or age greater than or equal to 55 or less with no menses for 12 or more months without an alternative medical cause and an FSH level > 40 IU/L); or",
            "criterions": [
                {
                    "exact_snippets": "Postmenopausal (surgically sterile",
                    "criterion": "postmenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "surgical sterility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "age > 55 years with no menses for 12 or more months without an alternative medical cause",
                    "criterion": "postmenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": ">",
                                "value": 55,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "menses absence duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        },
                        {
                            "requirement_type": "alternative medical cause",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "age greater than or equal to 55 or less with no menses for 12 or more months without an alternative medical cause and an FSH level > 40 IU/L",
                    "criterion": "postmenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": "<=",
                                "value": 55,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "menses absence duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        },
                        {
                            "requirement_type": "alternative medical cause",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "FSH level",
                            "expected_value": {
                                "operator": ">",
                                "value": 40,
                                "unit": "IU/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Of children bearing potential. These subjects must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Subject must agree to have a negative urine or serum beta-HCG test result during screening and repeated within 7 days prior to study drug (local labs are allowed) to be eligible.",
            "criterions": [
                {
                    "exact_snippets": "children bearing potential",
                    "criterion": "children bearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence)",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subject must agree to have a negative urine or serum beta-HCG test result during screening and repeated within 7 days prior to study drug",
                    "criterion": "beta-HCG test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject must voluntarily sign and date an informed consent",
            "criterions": [
                {
                    "exact_snippets": "Subject must voluntarily sign and date an informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "voluntary signing and dating",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects must be able to swallow pills",
            "criterions": [
                {
                    "exact_snippets": "Subjects must be able to swallow pills",
                    "criterion": "ability to swallow pills",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Subject cannot have had prior navitoclax or any BCL-XL therapy. Otherwise, there are no restrictions on any other prior therapies. Prior venetoclax is allowed.",
            "criterions": [
                {
                    "exact_snippets": "Subject cannot have had prior navitoclax",
                    "criterion": "prior navitoclax therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Subject cannot have had ... any BCL-XL therapy",
                    "criterion": "prior BCL-XL therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior venetoclax is allowed",
                    "criterion": "prior venetoclax therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject is eligible and willing to receive intensive chemotherapy for their specific disease.",
            "criterions": [
                {
                    "exact_snippets": "Subject is eligible ... to receive intensive chemotherapy",
                    "criterion": "eligibility for intensive chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to receive intensive chemotherapy",
                    "criterion": "willingness to receive intensive chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Anti-leukemic therapy within 14 days of first day of study treatment except for hydroxyurea. If on hydroxyurea, then subject needs to be off hydroxyurea at least 3 days prior to first dose of study treatment. If on venetoclax, then a wash-out period of at least five times the half-life of the treatment.",
            "criterions": [
                {
                    "exact_snippets": "Anti-leukemic therapy within 14 days of first day of study treatment",
                    "criterion": "anti-leukemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except for hydroxyurea. If on hydroxyurea, then subject needs to be off hydroxyurea at least 3 days prior to first dose of study treatment",
                    "criterion": "hydroxyurea",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "If on venetoclax, then a wash-out period of at least five times the half-life of the treatment",
                    "criterion": "venetoclax",
                    "requirements": [
                        {
                            "requirement_type": "wash-out period",
                            "expected_value": "at least five times the half-life of the treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject with known and active concurrent malignancy requiring treatment. Subjects with basal or squamous skin cancers or carcinomas in situ are allowed. Exception: hormonal or topical therapies are allowed.",
            "criterions": [
                {
                    "exact_snippets": "known and active concurrent malignancy requiring treatment",
                    "criterion": "concurrent malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "basal or squamous skin cancers or carcinomas in situ are allowed",
                    "criterion": "basal or squamous skin cancers or carcinomas in situ",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hormonal or topical therapies are allowed",
                    "criterion": "hormonal or topical therapies",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject has known active/uncontrolled HIV and on contraindicated medication due to drug-drug CYP inducer interaction. HIV testing is not required.",
            "criterions": [
                {
                    "exact_snippets": "Subject has known active/uncontrolled HIV",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active/uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "on contraindicated medication due to drug-drug CYP inducer interaction",
                    "criterion": "medication",
                    "requirements": [
                        {
                            "requirement_type": "interaction",
                            "expected_value": "contraindicated due to drug-drug CYP inducer interaction"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject has known and active CNS involvement with AML.",
            "criterions": [
                {
                    "exact_snippets": "known and active CNS involvement with AML",
                    "criterion": "CNS involvement with AML",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "known and active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:",
            "criterions": [
                {
                    "exact_snippets": "Evidence of other clinically significant uncontrolled condition(s)",
                    "criterion": "clinically significant uncontrolled condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled and/or active systemic infection (viral, bacterial or fungal). Controlled infections are allowed.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled and/or active systemic infection (viral, bacterial or fungal). Controlled infections are allowed.",
                    "criterion": "systemic infection",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled or active"
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "viral",
                                "bacterial",
                                "fungal"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Chronic, active hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate. Subjects that have prior HCV that has been definitively treated with negative HCV viral load prior to study initiation and no evidence of cirrhosis are allowed to participate.",
            "criterions": [
                {
                    "exact_snippets": "Chronic, active hepatitis B virus (HBV) ... requiring treatment.",
                    "criterion": "chronic active hepatitis B virus (HBV)",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Chronic, active ... hepatitis C (HCV) requiring treatment.",
                    "criterion": "chronic active hepatitis C (HCV)",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative)",
                    "criterion": "prior vaccination to HBV",
                    "requirements": [
                        {
                            "requirement_type": "serologic evidence",
                            "expected_value": [
                                "hepatitis B surface (HBs) antigen negative",
                                "anti-HBs antibody positive",
                                "anti-hepatitis B core (HBc) antibody negative"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "positive anti-HBc antibody from intravenous immunoglobulins (IVIG)",
                    "criterion": "positive anti-HBc antibody from IVIG",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior HCV that has been definitively treated with negative HCV viral load prior to study initiation and no evidence of cirrhosis",
                    "criterion": "prior HCV",
                    "requirements": [
                        {
                            "requirement_type": "definitive treatment",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "HCV viral load",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "evidence of cirrhosis",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recent diagnosis of myocardial infarction or worse heart failure within the last six months.",
            "criterions": [
                {
                    "exact_snippets": "Recent diagnosis of myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "worse heart failure within the last six months",
                    "criterion": "heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "worse"
                        },
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treatment with any moderate or strong CYP3A inducers (see Appendix D for examples) within 7 days prior to the first dose of study drug.",
            "criterions": [
                {
                    "exact_snippets": "Treatment with any moderate or strong CYP3A inducers",
                    "criterion": "CYP3A inducers",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "within 7 days prior to the first dose of study drug",
                    "criterion": "time since last treatment with CYP3A inducers",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Administration or consumption of any of the following within 3 days prior to the first dose of study drug:",
            "criterions": [
                {
                    "exact_snippets": "Administration or consumption of any of the following within 3 days prior to the first dose of study drug",
                    "criterion": "administration or consumption of specific substances",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 3 days prior to the first dose of study drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Grapefruit or grapefruit products",
            "criterions": [
                {
                    "exact_snippets": "Grapefruit or grapefruit products",
                    "criterion": "grapefruit consumption",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Seville oranges (including marmalade containing Seville oranges)",
            "criterions": [
                {
                    "exact_snippets": "Seville oranges (including marmalade containing Seville oranges)",
                    "criterion": "Seville oranges",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Star fruit",
            "criterions": [
                {
                    "exact_snippets": "Star fruit",
                    "criterion": "star fruit",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* White blood cell count (WBC) greater than or equal to 25 x 109/L. Exception: Subjects with myelofibrosis or MDS/MPN overlap syndrome may enter study with WBC greater than or equal 25 x 109/L on the first day of therapy only if the absolute blast count is < 5 x 109/L; hospitalization for subjects with this particular disease subset is required during dose ramp-up of venetoclax for TLS monitoring. This criterion is intended to exclude AML patients at high risk of TLS, but permit entry of patients with MF or CMML who frequently have leukocytosis without AML transformation who are at low risk for TLS.",
            "criterions": [
                {
                    "exact_snippets": "White blood cell count (WBC) greater than or equal to 25 x 109/L",
                    "criterion": "white blood cell count (WBC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 25,
                                "unit": "x 109/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "absolute blast count is < 5 x 109/L",
                    "criterion": "absolute blast count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "x 109/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hospitalization for subjects with this particular disease subset is required during dose ramp-up of venetoclax for TLS monitoring",
                    "criterion": "hospitalization during dose ramp-up of venetoclax for TLS monitoring",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ongoing requirement for anticoagulation with the exception of low-dose anticoagulation medications used to maintain patency of a central venous catheter or for deep venous thrombosis prophylaxis. Antiplatelet agents such as aspirin and clopidogrel are not allowed if platelet count < 50 x 109/L.",
            "criterions": [
                {
                    "exact_snippets": "Ongoing requirement for anticoagulation",
                    "criterion": "anticoagulation requirement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "low-dose anticoagulation medications used to maintain patency of a central venous catheter or for deep venous thrombosis prophylaxis",
                    "criterion": "low-dose anticoagulation medications",
                    "requirements": [
                        {
                            "requirement_type": "purpose",
                            "expected_value": [
                                "maintain patency of a central venous catheter",
                                "deep venous thrombosis prophylaxis"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Antiplatelet agents such as aspirin and clopidogrel are not allowed",
                    "criterion": "antiplatelet agents",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "platelet count < 50 x 109/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known history of immune thrombocytopenia that previously required therapy.",
            "criterions": [
                {
                    "exact_snippets": "Known history of immune thrombocytopenia",
                    "criterion": "immune thrombocytopenia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "previously required therapy",
                    "criterion": "immune thrombocytopenia",
                    "requirements": [
                        {
                            "requirement_type": "previous therapy requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known history of platelet refractoriness and HLA alloimmunization prior to study start.",
            "criterions": [
                {
                    "exact_snippets": "Known history of platelet refractoriness",
                    "criterion": "platelet refractoriness",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HLA alloimmunization prior to study start",
                    "criterion": "HLA alloimmunization",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of serious or life-threatening bleeding in last 12 months that has not been definitively treated.",
            "criterions": [
                {
                    "exact_snippets": "History of serious or life-threatening bleeding",
                    "criterion": "bleeding history",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious or life-threatening"
                        }
                    ]
                },
                {
                    "exact_snippets": "in last 12 months",
                    "criterion": "bleeding history",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "last 12 months"
                        }
                    ]
                },
                {
                    "exact_snippets": "that has not been definitively treated",
                    "criterion": "bleeding history",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "not definitively treated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled, systemic infection (viral, bacterial, or fungal). Antibiotic use is permitted. (See Section 5.5 for concomitant drugs)",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled, systemic infection (viral, bacterial, or fungal)",
                    "criterion": "systemic infection",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "viral",
                                "bacterial",
                                "fungal"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active and known SARS-CoV-2 infection.",
            "criterions": [
                {
                    "exact_snippets": "Active and known SARS-CoV-2 infection",
                    "criterion": "SARS-CoV-2 infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "awareness",
                            "expected_value": "known"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If a subject has signs/symptoms suggestive of SARS-CoV-2 infection, then the subject must undergo molecular (e.g. PCR) testing to rule out SARS-CoV-2 infection.",
            "criterions": [
                {
                    "exact_snippets": "signs/symptoms suggestive of SARS-CoV-2 infection",
                    "criterion": "SARS-CoV-2 infection signs/symptoms",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "molecular (e.g. PCR) testing to rule out SARS-CoV-2 infection",
                    "criterion": "SARS-CoV-2 infection",
                    "requirements": [
                        {
                            "requirement_type": "molecular testing",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects positive for active SARS-CoV-2 infection may re-screen after they meet either criteria A or B indicating SARS-CoV-2 infection has resolved with viral clearance: A) ≥14 days since first the PCR test result in an asymptomatic subject; OR B) ≥14 days since recovery, defined as resolution of fever without use of anti-pyretics and improvement in symptoms.",
            "criterions": [
                {
                    "exact_snippets": "positive for active SARS-CoV-2 infection",
                    "criterion": "active SARS-CoV-2 infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "≥14 days since first the PCR test result in an asymptomatic subject",
                    "criterion": "time since first PCR test result in an asymptomatic subject",
                    "requirements": [
                        {
                            "requirement_type": "time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "≥14 days since recovery",
                    "criterion": "time since recovery",
                    "requirements": [
                        {
                            "requirement_type": "time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "resolution of fever without use of anti-pyretics",
                    "criterion": "fever resolution without anti-pyretics",
                    "requirements": [
                        {
                            "requirement_type": "resolution",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "improvement in symptoms",
                    "criterion": "symptom improvement",
                    "requirements": [
                        {
                            "requirement_type": "improvement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and/or would make the subject inappropriate for enrollment into this study.",
            "criterions": [
                {
                    "exact_snippets": "Other severe acute or chronic medical or psychiatric condition",
                    "criterion": "medical or psychiatric condition",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": [
                                "acute",
                                "chronic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "laboratory abnormality",
                    "criterion": "laboratory abnormality",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Vaccination with live, attenuated vaccines ≤4 weeks prior to initiation of study treatment or anticipation of need for such a vaccine during the study. All other recommended vaccinations including COVID19 is permitted.",
            "criterions": [
                {
                    "exact_snippets": "Vaccination with live, attenuated vaccines ≤4 weeks prior to initiation of study treatment",
                    "criterion": "vaccination with live, attenuated vaccines",
                    "requirements": [
                        {
                            "requirement_type": "time since vaccination",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "anticipation of need for such a vaccine during the study",
                    "criterion": "need for live, attenuated vaccine",
                    "requirements": [
                        {
                            "requirement_type": "anticipated need during study",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Aspartate transaminase (AST) and alanine transaminase (ALT) < 3 x ULN",
            "criterions": [
                {
                    "exact_snippets": "Aspartate transaminase (AST) < 3 x ULN",
                    "criterion": "Aspartate transaminase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine transaminase (ALT) < 3 x ULN",
                    "criterion": "alanine transaminase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}