{
    "info": {
        "nct_id": "NCT03240120",
        "official_title": "A Prospective Study of Dabigatran Etexilate as Primary Treatment of Malignancy Associated Venous Thromboembolism",
        "inclusion_criteria": "1. are aged 18 years or above;\n2. have acute symptomatic deep vein thrombosis or pulmonary embolism with objective confirmation;\n3. have active cancer, which is defined as a diagnosis of cancer other than basal cell or squamous cell carcinoma of skin within six months before enrollment, any treatment for cancer within the previous six months or recurrent or metastatic cancer.\n4. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.\n5. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. have Eastern Cooperative Oncology Group (ECOG) performance status score of > 2 at the time of randomization;\n2. have life expectancy of less than 3 months;\n3. have active bleeding, are at high risk of bleeding, or have contraindications to anticoagulant treatment;\n4. receive thrombectomy or fibrinolytic agent to treat the current episode of VTE;\n5. receive more than 72 hours pre-treatment with therapeutic dosages of anticoagulant treatment prior to randomization to treat the current VTE episode;\n6. are already on long term oral anticoagulation;\n7. are on low molecular weight heparin for indications other than VTE;\n8. have platelet count of less than 100 x 109/L;\n9. are on dual antiplatelet therapy;\n10. have a serum creatinine level of more than 220 umol/L or have a calculated creatinine clearance (CrCl) of less than 30 ml/min;\n11. have alanine aminotransferase level more than 2 times the upper limit of normal range or cirrhosis;\n12. have history of heparin induced thrombocytopenia;\n13. are on treatment of potent inhibitors or inducers of P-glycoprotein.\n14. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. are aged 18 years or above;",
            "criterions": [
                {
                    "exact_snippets": "aged 18 years or above",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. have acute symptomatic deep vein thrombosis or pulmonary embolism with objective confirmation;",
            "criterions": [
                {
                    "exact_snippets": "acute symptomatic deep vein thrombosis",
                    "criterion": "deep vein thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "acuteness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pulmonary embolism",
                    "criterion": "pulmonary embolism",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "acuteness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "objective confirmation",
                    "criterion": "objective confirmation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. have active cancer, which is defined as a diagnosis of cancer other than basal cell or squamous cell carcinoma of skin within six months before enrollment, any treatment for cancer within the previous six months or recurrent or metastatic cancer.",
            "criterions": [
                {
                    "exact_snippets": "active cancer, which is defined as a diagnosis of cancer other than basal cell or squamous cell carcinoma of skin within six months before enrollment",
                    "criterion": "active cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "cancer other than basal cell or squamous cell carcinoma of skin"
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "any treatment for cancer within the previous six months",
                    "criterion": "cancer treatment",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "recurrent or metastatic cancer",
                    "criterion": "cancer status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "recurrent",
                                "metastatic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.",
            "criterions": [
                {
                    "exact_snippets": "Female subjects of childbearing potential",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive status",
                            "expected_value": "childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to use 2 methods of birth control",
                    "criterion": "birth control methods",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "methods"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "be surgically sterile",
                    "criterion": "surgical sterilization",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "abstain from heterosexual activity",
                    "criterion": "sexual activity",
                    "requirements": [
                        {
                            "requirement_type": "abstinence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "for the course of the study through 120 days after the last dose of study medication",
                    "criterion": "duration of birth control or abstinence",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "course of the study through 120 days after the last dose of study medication"
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects of childbearing potential are those who have not been surgically sterilized",
                    "criterion": "surgical sterilization",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "have not been free from menses for > 1 year",
                    "criterion": "menstrual status",
                    "requirements": [
                        {
                            "requirement_type": "duration without menses",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.",
            "criterions": [
                {
                    "exact_snippets": "Male subjects should agree to use an adequate method of contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "starting with the first dose of study therapy through 120 days after the last dose of study therapy",
                    "criterion": "contraception use duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "from first dose through 120 days after last dose"
                        }
                    ]
                }
            ]
        },
        {
            "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": "1. have Eastern Cooperative Oncology Group (ECOG) performance status score of > 2 at the time of randomization;",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status score of > 2",
                    "criterion": "ECOG performance status score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. have life expectancy of less than 3 months;",
            "criterions": [
                {
                    "exact_snippets": "life expectancy of less than 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. have active bleeding, are at high risk of bleeding, or have contraindications to anticoagulant treatment;",
            "criterions": [
                {
                    "exact_snippets": "have active bleeding",
                    "criterion": "active bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "are at high risk of bleeding",
                    "criterion": "risk of bleeding",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "high"
                        }
                    ]
                },
                {
                    "exact_snippets": "have contraindications to anticoagulant treatment",
                    "criterion": "contraindications to anticoagulant treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. receive thrombectomy or fibrinolytic agent to treat the current episode of VTE;",
            "criterions": [
                {
                    "exact_snippets": "receive thrombectomy",
                    "criterion": "thrombectomy",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "receive ... fibrinolytic agent",
                    "criterion": "fibrinolytic agent",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. receive more than 72 hours pre-treatment with therapeutic dosages of anticoagulant treatment prior to randomization to treat the current VTE episode;",
            "criterions": [
                {
                    "exact_snippets": "receive more than 72 hours pre-treatment with therapeutic dosages of anticoagulant treatment",
                    "criterion": "anticoagulant treatment pre-treatment duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 72,
                                "unit": "hours"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. are already on long term oral anticoagulation;",
            "criterions": [
                {
                    "exact_snippets": "are already on long term oral anticoagulation",
                    "criterion": "oral anticoagulation",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "long term"
                        },
                        {
                            "requirement_type": "current use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. are on low molecular weight heparin for indications other than VTE;",
            "criterions": [
                {
                    "exact_snippets": "are on low molecular weight heparin",
                    "criterion": "low molecular weight heparin usage",
                    "requirements": [
                        {
                            "requirement_type": "indication",
                            "expected_value": {
                                "operator": "!=",
                                "value": 1,
                                "unit": "VTE"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. have platelet count of less than 100 x 109/L;",
            "criterions": [
                {
                    "exact_snippets": "platelet count of less than 100 x 109/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 100,
                                "unit": "x 109/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. are on dual antiplatelet therapy;",
            "criterions": [
                {
                    "exact_snippets": "on dual antiplatelet therapy",
                    "criterion": "dual antiplatelet therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. have a serum creatinine level of more than 220 umol/L or have a calculated creatinine clearance (CrCl) of less than 30 ml/min;",
            "criterions": [
                {
                    "exact_snippets": "serum creatinine level of more than 220 umol/L",
                    "criterion": "serum creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 220,
                                "unit": "umol/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "calculated creatinine clearance (CrCl) of less than 30 ml/min",
                    "criterion": "calculated creatinine clearance (CrCl)",
                    "requirements": [
                        {
                            "requirement_type": "clearance",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "ml/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. have alanine aminotransferase level more than 2 times the upper limit of normal range or cirrhosis;",
            "criterions": [
                {
                    "exact_snippets": "alanine aminotransferase level more than 2 times the upper limit of normal range",
                    "criterion": "alanine aminotransferase level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "times the upper limit of normal range"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "cirrhosis",
                    "criterion": "cirrhosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. have history of heparin induced thrombocytopenia;",
            "criterions": [
                {
                    "exact_snippets": "history of heparin induced thrombocytopenia",
                    "criterion": "heparin induced thrombocytopenia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. are on treatment of potent inhibitors or inducers of P-glycoprotein.",
            "criterions": [
                {
                    "exact_snippets": "treatment of potent inhibitors or inducers of P-glycoprotein",
                    "criterion": "treatment with P-glycoprotein inhibitors or inducers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.",
            "criterions": [
                {
                    "exact_snippets": "Is pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "expecting to conceive",
                    "criterion": "expecting to conceive",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "father children",
                    "criterion": "expecting to father children",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}