{
    "info": {
        "nct_id": "NCT02825420",
        "official_title": "NonInterventional, Multicenter, Prospective, European Study to Describe the Effectiveness of Trabectedin + PLD in the Treatment of Relapsed Ovarian Cancer (ROC) Patients According to SmPC Regardless of Previous Use of an Antiangiogenic Drug",
        "inclusion_criteria": "* Women aged 18 years or older.\n* Presence of platinum-sensitive relapsed ovarian cancer.\n* Treatment and treated indication according to local label SmPC and reimbursement for trabectedin and PLD treatment.\n* Prior treatment with a minimum of 1 cycle of trabectedin + PLD according to SmPC before inclusion in the study, and no more than 3 previous treatment lines.\n* Written informed consent indicating that patients understand the purpose and procedures and are willing to participate in the study.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* None",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Women aged 18 years or older.",
            "criterions": [
                {
                    "exact_snippets": "Women",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected gender",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "aged 18 years or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of platinum-sensitive relapsed ovarian cancer.",
            "criterions": [
                {
                    "exact_snippets": "Presence of platinum-sensitive relapsed ovarian cancer.",
                    "criterion": "platinum-sensitive relapsed ovarian cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treatment and treated indication according to local label SmPC and reimbursement for trabectedin and PLD treatment.",
            "criterions": [
                {
                    "exact_snippets": "Treatment and treated indication according to local label SmPC",
                    "criterion": "treatment and treated indication",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": "local label SmPC"
                        }
                    ]
                },
                {
                    "exact_snippets": "reimbursement for trabectedin and PLD treatment",
                    "criterion": "reimbursement",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": [
                                "trabectedin",
                                "PLD treatment"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment with a minimum of 1 cycle of trabectedin + PLD according to SmPC before inclusion in the study, and no more than 3 previous treatment lines.",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with a minimum of 1 cycle of trabectedin + PLD",
                    "criterion": "prior treatment with trabectedin + PLD",
                    "requirements": [
                        {
                            "requirement_type": "minimum cycles",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "cycle"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no more than 3 previous treatment lines",
                    "criterion": "previous treatment lines",
                    "requirements": [
                        {
                            "requirement_type": "maximum number",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "treatment lines"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Written informed consent indicating that patients understand the purpose and procedures and are willing to participate in the study.",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent indicating that patients understand the purpose and procedures and are willing to participate in the study.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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 be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "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": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* None",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}