{
"info": {
"nct_id": "NCT00539331",
"official_title": "A Two-Part Study in Japanese Patients With Advanced or Metastatic NSCLC. Open-Label Phase I to Assess the Safety & Tolerability of AZD2171 in Combination With Pac/Carb, Then a Phase II, Randomised, Double-Blind Study to Assess the Efficacy of Pac/Carb Alone and in Combination With AZD2171 and Pac/Carb",
"inclusion_criteria": "* Having histologically or cytologically confirmed NSCLC\n* Patients with previously untreated advanced/metastatic (Stage IIIB/IV) or postsurgery recurrent NSCLC\n* WHO performance status 0-1\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Untreated unstable brain or meningeal metastases\n* Patient with inappropriate laboratory tests values\n* Patient with poorly controlled hypertension",
"miscellaneous_criteria": ""
},
"inclusion_lines": [],
"exclusion_lines": [
{
"identified_line": {
"line": "* Untreated unstable brain or meningeal metastases",
"criterions": [
{
"exact_snippets": "Untreated unstable brain ... metastases",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "untreated"
}
},
{
"exact_snippets": "Untreated unstable brain ... metastases",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "stability",
"expected_value": "unstable"
}
},
{
"exact_snippets": "Untreated unstable ... meningeal metastases",
"criterion": "meningeal metastases",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "untreated"
}
},
{
"exact_snippets": "Untreated unstable ... meningeal metastases",
"criterion": "meningeal metastases",
"requirement": {
"requirement_type": "stability",
"expected_value": "unstable"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Untreated unstable brain ... metastases",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "untreated"
}
},
{
"exact_snippets": "Untreated unstable brain ... metastases",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "stability",
"expected_value": "unstable"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Untreated unstable ... meningeal metastases",
"criterion": "meningeal metastases",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "untreated"
}
},
{
"exact_snippets": "Untreated unstable ... meningeal metastases",
"criterion": "meningeal metastases",
"requirement": {
"requirement_type": "stability",
"expected_value": "unstable"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patient with inappropriate laboratory tests values",
"criterions": [
{
"exact_snippets": "inappropriate laboratory tests values",
"criterion": "laboratory tests values",
"requirement": {
"requirement_type": "appropriateness",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
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"criterion": "laboratory tests values",
"requirement": {
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"expected_value": false
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]
}
},
{
"identified_line": {
"line": "* Patient with poorly controlled hypertension",
"criterions": [
{
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"criterion": "hypertension",
"requirement": {
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"expected_value": "poorly controlled"
}
}
]
},
"logical_structure": {
"not_criteria": {
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"criterion": "hypertension",
"requirement": {
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"expected_value": "poorly controlled"
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Having histologically or cytologically confirmed NSCLC",
"criterions": [
{
"exact_snippets": "histologically or cytologically confirmed NSCLC",
"criterion": "NSCLC",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": [
"histologically",
"cytologically"
]
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Patients with previously untreated advanced/metastatic (Stage IIIB/IV) or postsurgery recurrent NSCLC",
"criterions": [
{
"exact_snippets": "previously untreated advanced/metastatic (Stage IIIB/IV)",
"criterion": "NSCLC stage",
"requirement": {
"requirement_type": "stage",
"expected_value": [
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"IV"
]
}
},
{
"exact_snippets": "previously untreated advanced/metastatic",
"criterion": "treatment history",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "untreated"
}
},
{
"exact_snippets": "postsurgery recurrent NSCLC",
"criterion": "NSCLC recurrence",
"requirement": {
"requirement_type": "recurrence status",
"expected_value": "postsurgery recurrent"
}
}
]
},
"logical_structure": {
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"criterion": "failed",
"requirement": {
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"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* WHO performance status 0-1",
"criterions": [
{
"exact_snippets": "WHO performance status 0-1",
"criterion": "WHO performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 1,
"unit": "N/A"
}
]
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
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"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}