{
    "info": {
        "nct_id": "NCT02749617",
        "official_title": "A Pilot Study Investigating Apixaban and Dexamethasone InterAction in Multiple Myeloma",
        "inclusion_criteria": "* Patients with diagnosis of multiple myeloma according to criteria of the International Myeloma Working Group\n* Patients in whom a LEN-DEX-based treatment regimen is indicated\n* Adult patients ≥ 19 years of age who are able to freely provide informed consent\nHealthy volunteers allowed\nMust have minimum age of 19 Years",
        "exclusion_criteria": "* Concomitant antiplatelet or anticoagulant use\n* Calculated creatinine clearance < 30 mL/min by Cockcroft-Gault formula\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times upper limit of normal (ULN)\n* Total bilirubin > 2 x ULN\n* Thrombocytopenia < 50 x 10 gigalitres (Gl)\n* High bleeding risk or spontaneously prolonged prothrombin time or activated partial thromboplastin time > 1.5 x ULN\n* Body weight <50 or >120 kg\n* Concomitant use of CYP3A4 or p-glycoprotein inducers or inhibitors\n* Use of Ginkgo biloba or St. John's Wort within 14 days before first dose of study drug\n* Dexamethasone use within last 3 months\n* Women of Childbearing potential without proper contraceptive measures, pregnancy or breast feeding\n* Life expectancy less than 3 months\n* Inability to swallow or issues with malabsorption\n* Any other medical, social, logistical, geographical or psychological factors, which in the opinion of the investigator, would prohibit follow-up, compliance and study completion",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients with diagnosis of multiple myeloma according to criteria of the International Myeloma Working Group",
            "criterions": [
                {
                    "exact_snippets": "diagnosis of multiple myeloma",
                    "criterion": "multiple myeloma diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "according to criteria of the International Myeloma Working Group",
                    "criterion": "International Myeloma Working Group criteria",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients in whom a LEN-DEX-based treatment regimen is indicated",
            "criterions": [
                {
                    "exact_snippets": "LEN-DEX-based treatment regimen is indicated",
                    "criterion": "LEN-DEX-based treatment regimen",
                    "requirements": [
                        {
                            "requirement_type": "indication",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adult patients ≥ 19 years of age who are able to freely provide informed consent",
            "criterions": [
                {
                    "exact_snippets": "Adult patients ≥ 19 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 19,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "able to freely provide informed consent",
                    "criterion": "ability to provide informed consent",
                    "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 19 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 19 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 19,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Concomitant antiplatelet or anticoagulant use",
            "criterions": [
                {
                    "exact_snippets": "Concomitant antiplatelet or anticoagulant use",
                    "criterion": "antiplatelet use",
                    "requirements": [
                        {
                            "requirement_type": "concomitant use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Concomitant antiplatelet or anticoagulant use",
                    "criterion": "anticoagulant use",
                    "requirements": [
                        {
                            "requirement_type": "concomitant use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Calculated creatinine clearance < 30 mL/min by Cockcroft-Gault formula",
            "criterions": [
                {
                    "exact_snippets": "Calculated creatinine clearance < 30 mL/min by Cockcroft-Gault formula",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "calculation method",
                            "expected_value": "Cockcroft-Gault formula"
                        },
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times upper limit of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Alanine aminotransferase (ALT) ... > 3 times upper limit of normal (ULN)",
                    "criterion": "Alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate aminotransferase (AST) ... > 3 times upper limit of normal (ULN)",
                    "criterion": "aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin > 2 x ULN",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin > 2 x ULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Thrombocytopenia < 50 x 10 gigalitres (Gl)",
            "criterions": [
                {
                    "exact_snippets": "Thrombocytopenia < 50 x 10 gigalitres (Gl)",
                    "criterion": "thrombocytopenia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "x 10 gigalitres (Gl)"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* High bleeding risk or spontaneously prolonged prothrombin time or activated partial thromboplastin time > 1.5 x ULN",
            "criterions": [
                {
                    "exact_snippets": "High bleeding risk",
                    "criterion": "bleeding risk",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "high"
                        }
                    ]
                },
                {
                    "exact_snippets": "spontaneously prolonged prothrombin time",
                    "criterion": "prothrombin time",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "prolonged"
                        }
                    ]
                },
                {
                    "exact_snippets": "activated partial thromboplastin time > 1.5 x ULN",
                    "criterion": "activated partial thromboplastin time",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Body weight <50 or >120 kg",
            "criterions": [
                {
                    "exact_snippets": "Body weight <50 or >120 kg",
                    "criterion": "body weight",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 50,
                                        "unit": "kg"
                                    },
                                    {
                                        "operator": ">",
                                        "value": 120,
                                        "unit": "kg"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concomitant use of CYP3A4 or p-glycoprotein inducers or inhibitors",
            "criterions": [
                {
                    "exact_snippets": "Concomitant use of CYP3A4 or p-glycoprotein inducers or inhibitors",
                    "criterion": "concomitant use of CYP3A4 inducers or inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Concomitant use of CYP3A4 or p-glycoprotein inducers or inhibitors",
                    "criterion": "concomitant use of p-glycoprotein inducers or inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of Ginkgo biloba or St. John's Wort within 14 days before first dose of study drug",
            "criterions": [
                {
                    "exact_snippets": "Use of Ginkgo biloba ... within 14 days before first dose of study drug",
                    "criterion": "Ginkgo biloba use",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Use of ... St. John's Wort within 14 days before first dose of study drug",
                    "criterion": "St. John's Wort use",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Dexamethasone use within last 3 months",
            "criterions": [
                {
                    "exact_snippets": "Dexamethasone use within last 3 months",
                    "criterion": "Dexamethasone use",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within last 3 months"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of Childbearing potential without proper contraceptive measures, pregnancy or breast feeding",
            "criterions": [
                {
                    "exact_snippets": "Women of Childbearing potential",
                    "criterion": "women of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "without proper contraceptive measures",
                    "criterion": "contraceptive measures",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy less than 3 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy less than 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability to swallow or issues with malabsorption",
            "criterions": [
                {
                    "exact_snippets": "Inability to swallow",
                    "criterion": "swallowing ability",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "issues with malabsorption",
                    "criterion": "malabsorption",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any other medical, social, logistical, geographical or psychological factors, which in the opinion of the investigator, would prohibit follow-up, compliance and study completion",
            "criterions": [
                {
                    "exact_snippets": "Any other medical ... factors",
                    "criterion": "medical factors",
                    "requirements": [
                        {
                            "requirement_type": "opinion of the investigator",
                            "expected_value": "prohibit follow-up, compliance and study completion"
                        }
                    ]
                },
                {
                    "exact_snippets": "Any other ... social ... factors",
                    "criterion": "social factors",
                    "requirements": [
                        {
                            "requirement_type": "opinion of the investigator",
                            "expected_value": "prohibit follow-up, compliance and study completion"
                        }
                    ]
                },
                {
                    "exact_snippets": "Any other ... logistical ... factors",
                    "criterion": "logistical factors",
                    "requirements": [
                        {
                            "requirement_type": "opinion of the investigator",
                            "expected_value": "prohibit follow-up, compliance and study completion"
                        }
                    ]
                },
                {
                    "exact_snippets": "Any other ... geographical ... factors",
                    "criterion": "geographical factors",
                    "requirements": [
                        {
                            "requirement_type": "opinion of the investigator",
                            "expected_value": "prohibit follow-up, compliance and study completion"
                        }
                    ]
                },
                {
                    "exact_snippets": "Any other ... psychological factors",
                    "criterion": "psychological factors",
                    "requirements": [
                        {
                            "requirement_type": "opinion of the investigator",
                            "expected_value": "prohibit follow-up, compliance and study completion"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}