{
    "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",
                    "requirement_type": "diagnosis",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "criteria of the International Myeloma Working Group"
                    ],
                    "criterion": "International Myeloma Working Group criteria",
                    "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",
                    "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"
                    ],
                    "criterion": "age group",
                    "requirement_type": "category",
                    "expected_value": "adult"
                },
                {
                    "exact_snippets": [
                        "≥ 19 years of age"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 19
                    }
                },
                {
                    "exact_snippets": [
                        "able to freely provide informed consent"
                    ],
                    "criterion": "informed consent",
                    "requirement_type": "ability to provide",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 19 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 19 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 19
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Concomitant antiplatelet or anticoagulant use",
            "criterions": [
                {
                    "exact_snippets": [
                        "Concomitant antiplatelet"
                    ],
                    "criterion": "antiplatelet use",
                    "requirement_type": "concomitant use",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Concomitant",
                        "anticoagulant use"
                    ],
                    "criterion": "anticoagulant use",
                    "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",
                        "Cockcroft-Gault formula"
                    ],
                    "criterion": "creatinine clearance",
                    "requirement_type": "calculation",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 30
                            }
                        ]
                    }
                }
            ]
        },
        {
            "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)",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 3
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "aspartate aminotransferase (AST)",
                        " > 3 times upper limit of normal (ULN)"
                    ],
                    "criterion": "aspartate aminotransferase (AST)",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 3
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Total bilirubin > 2 x ULN",
            "criterions": [
                {
                    "exact_snippets": [
                        "Total bilirubin > 2 x ULN"
                    ],
                    "criterion": "total bilirubin",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 2
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Total bilirubin > 2 x ULN"
                    ],
                    "criterion": "ULN",
                    "requirement_type": "reference",
                    "expected_value": "standard"
                }
            ]
        },
        {
            "line": "* Thrombocytopenia < 50 x 10 gigalitres (Gl)",
            "criterions": [
                {
                    "exact_snippets": [
                        "Thrombocytopenia < 50 x 10 gigalitres (Gl)"
                    ],
                    "criterion": "thrombocytopenia",
                    "requirement_type": "severity",
                    "expected_value": {
                        "operator": "<",
                        "value": 500
                    }
                }
            ]
        },
        {
            "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",
                    "requirement_type": "severity",
                    "expected_value": "high"
                },
                {
                    "exact_snippets": [
                        "spontaneously prolonged prothrombin time"
                    ],
                    "criterion": "prothrombin time",
                    "requirement_type": "duration",
                    "expected_value": "prolonged"
                },
                {
                    "exact_snippets": [
                        "activated partial thromboplastin time > 1.5 x ULN"
                    ],
                    "criterion": "activated partial thromboplastin time",
                    "requirement_type": "comparison",
                    "expected_value": {
                        "operator": ">",
                        "value": 1.5
                    }
                }
            ]
        },
        {
            "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": "CYP3A4 inducers or inhibitors",
                    "requirement_type": "concomitant use",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Concomitant use of CYP3A4 or p-glycoprotein inducers or inhibitors"
                    ],
                    "criterion": "p-glycoprotein inducers or inhibitors",
                    "requirement_type": "concomitant use",
                    "expected_value": true
                }
            ]
        },
        {
            "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"
                    ],
                    "criterion": "Ginkgo biloba",
                    "requirement_type": "use",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "Use of",
                        "St. John's Wort"
                    ],
                    "criterion": "St. John's Wort",
                    "requirement_type": "use",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "within 14 days before first dose of study drug"
                    ],
                    "criterion": "time since last use",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 14
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Dexamethasone use within last 3 months",
            "criterions": [
                {
                    "exact_snippets": [
                        "Dexamethasone use within last 3 months"
                    ],
                    "criterion": "Dexamethasone use",
                    "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": "childbearing potential",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "without proper contraceptive measures"
                    ],
                    "criterion": "contraceptive measures",
                    "requirement_type": "adequacy",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "pregnancy"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "presence",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "breast feeding"
                    ],
                    "criterion": "breast feeding",
                    "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",
                    "requirement_type": "duration",
                    "expected_value": {
                        "operator": "<",
                        "value": 3
                    }
                }
            ]
        },
        {
            "line": "* Inability to swallow or issues with malabsorption",
            "criterions": [
                {
                    "exact_snippets": [
                        "Inability to swallow"
                    ],
                    "criterion": "swallowing ability",
                    "requirement_type": "ability",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "issues with malabsorption"
                    ],
                    "criterion": "malabsorption",
                    "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": [
                        "medical",
                        "factors"
                    ],
                    "criterion": "medical factors",
                    "requirement_type": "prohibition",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "social",
                        "factors"
                    ],
                    "criterion": "social factors",
                    "requirement_type": "prohibition",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "logistical",
                        "factors"
                    ],
                    "criterion": "logistical factors",
                    "requirement_type": "prohibition",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "geographical",
                        "factors"
                    ],
                    "criterion": "geographical factors",
                    "requirement_type": "prohibition",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "psychological",
                        "factors"
                    ],
                    "criterion": "psychological factors",
                    "requirement_type": "prohibition",
                    "expected_value": true
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Body weight <50 or >120 kg",
            "criterions": [
                {
                    "exact_snippets": [
                        "Body weight <50"
                    ],
                    "criterion": "body weight",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 50
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Body weight >120"
                    ],
                    "criterion": "body weight",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 120
                            }
                        ]
                    }
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}