{
"info": {
"nct_id": "NCT05132101",
"official_title": "Analysis of the Real-world Prescription Pattern of Palbociclib Combination Therapy With Aromatase Inhibitor as a 1st Line Therapy in Metastatic Breast Cancer Patients Using the National Health Insurance Claims Data in South Korea",
"inclusion_criteria": "* Patients who were prescribed with palbociclib in combination with AI for at least 1 cycle during the index period\n* Patients who were diagnosed with BC during the index period\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Male\n* Prescribed with palbociclib during 12-month period preceding the index date",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Patients who were prescribed with palbociclib in combination with AI for at least 1 cycle during the index period",
"criterions": [
{
"exact_snippets": "prescribed with palbociclib in combination with AI",
"criterion": "medication regimen",
"requirements": [
{
"requirement_type": "combination",
"expected_value": [
"palbociclib",
"AI"
]
}
]
},
{
"exact_snippets": "at least 1 cycle during the index period",
"criterion": "treatment duration",
"requirements": [
{
"requirement_type": "minimum cycles",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "cycle"
}
}
]
}
]
},
{
"line": "* Patients who were diagnosed with BC during the index period",
"criterions": [
{
"exact_snippets": "Patients who were diagnosed with BC",
"criterion": "BC diagnosis",
"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": "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": [
{
"line": "* Male",
"criterions": [
{
"exact_snippets": "Male",
"criterion": "gender",
"requirements": [
{
"requirement_type": "value",
"expected_value": "male"
}
]
}
]
},
{
"line": "* Prescribed with palbociclib during 12-month period preceding the index date",
"criterions": [
{
"exact_snippets": "Prescribed with palbociclib during 12-month period preceding the index date",
"criterion": "palbociclib prescription",
"requirements": [
{
"requirement_type": "timeframe",
"expected_value": "12-month period preceding the index date"
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}