{
    "info": {
        "nct_id": "NCT05112666",
        "official_title": "Observational Studies in Cancer Associated Thrombosis for Rivaroxaban - United Kingdom Cohort (OSCAR-UK)",
        "inclusion_criteria": "* Be ≥18 years of age at the time of anticoagulation initiation\n* Have active cancer and acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE)\n* Treated with rivaroxaban (or any DOAC) or LMWH as their first recorded anticoagulant prescription 7 to 30 days post-acute CAT event diagnosis\n* Have been active in the data set for at least 12-months prior to the index event and had at least one provider visit in the 12-months prior to the acute VTE event\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Evidence of atrial fibrillation, recent hip/knee replacement (with 90 days of CAT), ongoing VTE treatment, valvular heart disease defined as any rheumatic heart disease, mitral stenosis or mitral valve repair/replacement\n* History of inferior vena cava filter before cohort entry\n* vitamin K antagonist (VKA) use between cohort entry and index day (initiation of DOAC or LMWH)\n* Evidence of any type of therapeutic anticoagulation use during all available look-back period per written prescription or patient self-report\n* Initiation of rivaroxaban or other DOACs or LMWH during the study period at non-therapeutic doses (e.g., enoxaparin at a dose other than 1 mg/kg twice daily or 1.5 mg/kg once daily; dalteparin at a dose other than 200 IU/kg of total body weight)\n* Pregnancy\n* Recording indicative of palliative care before cohort entry\n* Any clinically-relevant bleeding-related d hospitalization or VTE recurrence between the initial CAT and the start of observation",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Be ≥18 years of age at the time of anticoagulation initiation",
            "criterions": [
                {
                    "exact_snippets": "Be ≥18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have active cancer and acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE)",
            "criterions": [
                {
                    "exact_snippets": "active cancer",
                    "criterion": "cancer",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "acute deep vein thrombosis (DVT)",
                    "criterion": "deep vein thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "acute"
                        }
                    ]
                },
                {
                    "exact_snippets": "pulmonary embolism (PE)",
                    "criterion": "pulmonary embolism",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "acute"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treated with rivaroxaban (or any DOAC) or LMWH as their first recorded anticoagulant prescription 7 to 30 days post-acute CAT event diagnosis",
            "criterions": [
                {
                    "exact_snippets": "Treated with rivaroxaban (or any DOAC) or LMWH as their first recorded anticoagulant prescription",
                    "criterion": "first recorded anticoagulant prescription",
                    "requirements": [
                        {
                            "requirement_type": "medication",
                            "expected_value": [
                                "rivaroxaban",
                                "DOAC",
                                "LMWH"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "7 to 30 days post-acute CAT event diagnosis",
                    "criterion": "time since acute CAT event diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "time range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 7,
                                        "unit": "days"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 30,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have been active in the data set for at least 12-months prior to the index event and had at least one provider visit in the 12-months prior to the acute VTE event",
            "criterions": [
                {
                    "exact_snippets": "Have been active in the data set for at least 12-months prior to the index event",
                    "criterion": "activity in data set",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "had at least one provider visit in the 12-months prior to the acute VTE event",
                    "criterion": "provider visit",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "visit"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Evidence of atrial fibrillation, recent hip/knee replacement (with 90 days of CAT), ongoing VTE treatment, valvular heart disease defined as any rheumatic heart disease, mitral stenosis or mitral valve repair/replacement",
            "criterions": [
                {
                    "exact_snippets": "Evidence of atrial fibrillation",
                    "criterion": "atrial fibrillation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "recent hip/knee replacement (with 90 days of CAT)",
                    "criterion": "hip/knee replacement",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 90,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ongoing VTE treatment",
                    "criterion": "VTE treatment",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "ongoing"
                        }
                    ]
                },
                {
                    "exact_snippets": "valvular heart disease defined as any rheumatic heart disease, mitral stenosis or mitral valve repair/replacement",
                    "criterion": "valvular heart disease",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "rheumatic heart disease",
                                "mitral stenosis",
                                "mitral valve repair/replacement"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of inferior vena cava filter before cohort entry",
            "criterions": [
                {
                    "exact_snippets": "History of inferior vena cava filter",
                    "criterion": "inferior vena cava filter",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* vitamin K antagonist (VKA) use between cohort entry and index day (initiation of DOAC or LMWH)",
            "criterions": [
                {
                    "exact_snippets": "vitamin K antagonist (VKA) use between cohort entry and index day",
                    "criterion": "vitamin K antagonist (VKA) use",
                    "requirements": [
                        {
                            "requirement_type": "time period",
                            "expected_value": "between cohort entry and index day"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of any type of therapeutic anticoagulation use during all available look-back period per written prescription or patient self-report",
            "criterions": [
                {
                    "exact_snippets": "Evidence of any type of therapeutic anticoagulation use",
                    "criterion": "therapeutic anticoagulation use",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "during all available look-back period",
                    "criterion": "look-back period",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "all available"
                        }
                    ]
                },
                {
                    "exact_snippets": "per written prescription or patient self-report",
                    "criterion": "source of evidence",
                    "requirements": [
                        {
                            "requirement_type": "source",
                            "expected_value": [
                                "written prescription",
                                "patient self-report"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Initiation of rivaroxaban or other DOACs or LMWH during the study period at non-therapeutic doses (e.g., enoxaparin at a dose other than 1 mg/kg twice daily or 1.5 mg/kg once daily; dalteparin at a dose other than 200 IU/kg of total body weight)",
            "criterions": [
                {
                    "exact_snippets": "Initiation of rivaroxaban or other DOACs or LMWH during the study period",
                    "criterion": "initiation of anticoagulant therapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "during the study period"
                        }
                    ]
                },
                {
                    "exact_snippets": "non-therapeutic doses",
                    "criterion": "anticoagulant dose",
                    "requirements": [
                        {
                            "requirement_type": "therapeutic",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "enoxaparin at a dose other than 1 mg/kg twice daily or 1.5 mg/kg once daily",
                    "criterion": "enoxaparin dose",
                    "requirements": [
                        {
                            "requirement_type": "specific dose",
                            "expected_value": "other than 1 mg/kg twice daily or 1.5 mg/kg once daily"
                        }
                    ]
                },
                {
                    "exact_snippets": "dalteparin at a dose other than 200 IU/kg of total body weight",
                    "criterion": "dalteparin dose",
                    "requirements": [
                        {
                            "requirement_type": "specific dose",
                            "expected_value": "other than 200 IU/kg of total body weight"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recording indicative of palliative care before cohort entry",
            "criterions": [
                {
                    "exact_snippets": "Recording indicative of palliative care",
                    "criterion": "palliative care",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any clinically-relevant bleeding-related d hospitalization or VTE recurrence between the initial CAT and the start of observation",
            "criterions": [
                {
                    "exact_snippets": "clinically-relevant bleeding-related d hospitalization",
                    "criterion": "clinically-relevant bleeding-related hospitalization",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "VTE recurrence between the initial CAT and the start of observation",
                    "criterion": "VTE recurrence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}