{
"info": {
"nct_id": "NCT00447057",
"official_title": "A Phase 2 Study of Pemetrexed Versus Pemetrexed Plus Erlotinib in Second-Line Treatment in Patients With Nonsquamous NSCLC",
"inclusion_criteria": "* Histological or cytological diagnosis of locally advanced or metastatic NSCLC that is of nonsquamous histology and not amenable to curative therapy.\n* Failure of previous treatment with one prior platinum-based chemotherapy regimen.\n* Good performance status.\n* Adequate bone marrow reserve, renal and hepatic functions.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Serious concomitant systemic disease.\n* Inability to take oral medication.\n* Inability or unwillingness to take vitamin supplementation and corticosteroids.\n* Pregnancy / Breast-feeding.\n* Treatment with certain medicines that prevent blood from clotting.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Failure of previous treatment with one prior platinum-based chemotherapy regimen.",
"criterions": [
{
"exact_snippets": "Failure of previous treatment",
"criterion": "previous treatment",
"requirement": {
"requirement_type": "outcome",
"expected_value": "failure"
}
},
{
"exact_snippets": "one prior platinum-based chemotherapy regimen",
"criterion": "prior chemotherapy regimen",
"requirement": {
"requirement_type": "type",
"expected_value": "platinum-based"
}
},
{
"exact_snippets": "one prior platinum-based chemotherapy regimen",
"criterion": "prior chemotherapy regimen",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "=",
"value": 1,
"unit": "regimen"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Failure of previous treatment",
"criterion": "previous treatment",
"requirement": {
"requirement_type": "outcome",
"expected_value": "failure"
}
},
{
"exact_snippets": "one prior platinum-based chemotherapy regimen",
"criterion": "prior chemotherapy regimen",
"requirement": {
"requirement_type": "type",
"expected_value": "platinum-based"
}
}
]
},
{
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"criterion": "prior chemotherapy regimen",
"requirement": {
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"expected_value": {
"operator": "=",
"value": 1,
"unit": "regimen"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Good performance status.",
"criterions": [
{
"exact_snippets": "Good performance status.",
"criterion": "performance status",
"requirement": {
"requirement_type": "quality",
"expected_value": "good"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Good performance status.",
"criterion": "performance status",
"requirement": {
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}
}
]
}
},
{
"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": {
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"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
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}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
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"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Adequate bone marrow reserve, renal and hepatic functions.",
"criterions": [
{
"exact_snippets": "Adequate bone marrow reserve",
"criterion": "bone marrow reserve",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "adequate ... renal ... functions",
"criterion": "renal functions",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "adequate ... hepatic functions",
"criterion": "hepatic functions",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "Adequate bone marrow reserve",
"criterion": "bone marrow reserve",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "adequate ... renal ... functions",
"criterion": "renal functions",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "adequate ... hepatic functions",
"criterion": "hepatic functions",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Serious concomitant systemic disease.",
"criterions": [
{
"exact_snippets": "Serious concomitant systemic disease",
"criterion": "concomitant systemic disease",
"requirement": {
"requirement_type": "severity",
"expected_value": "serious"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Serious concomitant systemic disease",
"criterion": "concomitant systemic disease",
"requirement": {
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"expected_value": "serious"
}
}
}
},
{
"identified_line": {
"line": "* Inability to take oral medication.",
"criterions": [
{
"exact_snippets": "Inability to take oral medication",
"criterion": "ability to take oral medication",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Inability to take oral medication",
"criterion": "ability to take oral medication",
"requirement": {
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"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Inability or unwillingness to take vitamin supplementation and corticosteroids.",
"criterions": [
{
"exact_snippets": "Inability or unwillingness to take vitamin supplementation",
"criterion": "vitamin supplementation",
"requirement": {
"requirement_type": "ability or willingness",
"expected_value": true
}
},
{
"exact_snippets": "Inability or unwillingness to take ... corticosteroids",
"criterion": "corticosteroids",
"requirement": {
"requirement_type": "ability or willingness",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"not_criteria": {
"exact_snippets": "Inability or unwillingness to take vitamin supplementation",
"criterion": "vitamin supplementation",
"requirement": {
"requirement_type": "ability or willingness",
"expected_value": true
}
}
},
{
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"exact_snippets": "Inability or unwillingness to take ... corticosteroids",
"criterion": "corticosteroids",
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"expected_value": true
}
}
}
]
}
},
{
"identified_line": {
"line": "* Pregnancy / Breast-feeding.",
"criterions": [
{
"exact_snippets": "Pregnancy",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Breast-feeding",
"criterion": "breast-feeding",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "Pregnancy",
"criterion": "pregnancy",
"requirement": {
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"expected_value": false
}
},
{
"exact_snippets": "Breast-feeding",
"criterion": "breast-feeding",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Treatment with certain medicines that prevent blood from clotting.",
"criterions": [
{
"exact_snippets": "Treatment with certain medicines that prevent blood from clotting.",
"criterion": "treatment with anticoagulant medicines",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Treatment with certain medicines that prevent blood from clotting.",
"criterion": "treatment with anticoagulant medicines",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Histological or cytological diagnosis of locally advanced or metastatic NSCLC that is of nonsquamous histology and not amenable to curative therapy.",
"criterions": [
{
"exact_snippets": "Histological or cytological diagnosis",
"criterion": "diagnosis method",
"requirement": {
"requirement_type": "method",
"expected_value": [
"histological",
"cytological"
]
}
},
{
"exact_snippets": "locally advanced or metastatic NSCLC",
"criterion": "NSCLC stage",
"requirement": {
"requirement_type": "stage",
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"metastatic"
]
}
},
{
"exact_snippets": "nonsquamous histology",
"criterion": "NSCLC histology",
"requirement": {
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"expected_value": "nonsquamous"
}
},
{
"exact_snippets": "not amenable to curative therapy",
"criterion": "curative therapy eligibility",
"requirement": {
"requirement_type": "eligibility",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
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]
}
},
{
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]
}
}
]
},
{
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"criterion": "NSCLC stage",
"requirement": {
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]
}
},
{
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]
}
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}
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{
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}
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{
"exact_snippets": "not amenable to curative therapy",
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"requirement": {
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"expected_value": false
}
}
]
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}