{
    "info": {
        "nct_id": "NCT05184257",
        "official_title": "The Effectiveness of Zoladex® 10.8 mg Compared to Zoladex® 3.6mg in the Treatment of Premenopausal and Perimenopausal Hormone Receptor Positive Breast Cancer: A Real-World Study",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion Criteria\n\n* Diagnosed with primary breast cancer\n* Female, ≥18 years old (at index date)\n* HR positive\n* Receive Zoladex® 10.8 mg or Zoladex® 3.6 mg treatment\n* Premenopausal status prior to the treatment of Zoladex®. Baseline premenopausal status will be confirmed if the patient's last E2 measurement within 180 days prior to the index date indicated premenopausal status or there was a recorded menstrual history within 180 days prior to the index date\n* At least one actual or expected E2 testing measurement within 8-28 weeks of the index date Exclusion Criteria\n* Patients received concurrent treatments that may affect E2 testing results"
    },
    "inclusion_lines": [
        {
            "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": "expected_value",
                            "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": [
        {
            "line": "* Diagnosed with primary breast cancer",
            "criterions": [
                {
                    "exact_snippets": "Diagnosed with primary breast cancer",
                    "criterion": "primary breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female, ≥18 years old (at index date)",
            "criterions": [
                {
                    "exact_snippets": "Female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "≥18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HR positive",
            "criterions": [
                {
                    "exact_snippets": "HR positive",
                    "criterion": "hormone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Receive Zoladex® 10.8 mg or Zoladex® 3.6 mg treatment",
            "criterions": [
                {
                    "exact_snippets": "Receive Zoladex® 10.8 mg or Zoladex® 3.6 mg treatment",
                    "criterion": "Zoladex® treatment",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": [
                                "10.8 mg",
                                "3.6 mg"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Premenopausal status prior to the treatment of Zoladex®. Baseline premenopausal status will be confirmed if the patient's last E2 measurement within 180 days prior to the index date indicated premenopausal status or there was a recorded menstrual history within 180 days prior to the index date",
            "criterions": [
                {
                    "exact_snippets": "Premenopausal status prior to the treatment of Zoladex®",
                    "criterion": "premenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior to the treatment of Zoladex®"
                        }
                    ]
                },
                {
                    "exact_snippets": "Baseline premenopausal status will be confirmed if the patient's last E2 measurement within 180 days prior to the index date indicated premenopausal status",
                    "criterion": "E2 measurement",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 180 days prior to the index date"
                        },
                        {
                            "requirement_type": "indication",
                            "expected_value": "premenopausal status"
                        }
                    ]
                },
                {
                    "exact_snippets": "recorded menstrual history within 180 days prior to the index date",
                    "criterion": "menstrual history",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 180 days prior to the index date"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least one actual or expected E2 testing measurement within 8-28 weeks of the index date Exclusion Criteria",
            "criterions": [
                {
                    "exact_snippets": "At least one actual or expected E2 testing measurement within 8-28 weeks of the index date",
                    "criterion": "E2 testing measurement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 8,
                                        "unit": "weeks"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 28,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients received concurrent treatments that may affect E2 testing results",
            "criterions": [
                {
                    "exact_snippets": "concurrent treatments that may affect E2 testing results",
                    "criterion": "concurrent treatments",
                    "requirements": [
                        {
                            "requirement_type": "impact on E2 testing results",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Inclusion Criteria",
            "criterions": []
        }
    ]
}