{
"info": {
"nct_id": "NCT02215720",
"official_title": "Phase I Study of Temsirolimus and Cetuximab in Adults Patients With Advanced or Metastatic Solid Tumors",
"inclusion_criteria": "* Patients with malignant tumor confirmed histologically or cytologically who does not respond to usual therapeutics or for whom there is no curative treatment\n* Age >/= 18 years\n* ECOG 0 or 1\n* Life expectancy >/= 12 weeks\n* Grade </=1 for all adverse effects related to previous therapy or surgery (except for alopecia)\n* Appropriate organic functions as defined:\n* ASAT and ALAT </= 2.5xLSN or ASAT and ALAT </= 5xLSN in case of inappropriate hepatic function due to the underlying disease\n* Bilirubin </= 1.5xLSN\n* Albumin >/= 3.0 g/dL\n* Neutrophil counts (PNN) >/= 1 500/mL\n* Platelets >/= 100 000/mL\n* Hemoglobin >/= 9.0 g/dL\n* Creatinin </= 1.5xLSN\n* Cooperative patients able to respect the protocol\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Treatment by chemotherapy, radiotherapy, surgery or the two compounds of the study within 4 weeks before the inclusion\n* Previous treatment with an association of mTOR inhibitor or EGFR inhibitor\n* Diagnosis of a secondary cancer within the last 3 years except for a basal-cell carcinoma, cutaneous spinocellular cancer or in situ carcinoma well treated\n* Grade >/= 2 nephropathy according to NCI CTCAE\n* Current treatment with curative dose of coumadin or heparin of low molecular weight\n* Previous uncontrolled brain metastases, medullar compression or carcinomatosis meningitis or any proof of leptomeningeal pathology or metastasis.\n* Presence of one og those pathologies during the last 12 months before the inclusion:\n* myocardial infarction\n* angina pectoris\n* bypass of coronal or peripheral arteries\n* heart failure\n* stroke\n* cerebral bleeding\n* pulmonary embolism\n* Grade 3 bleeding according to NCI CTCAE criteria less than 3 weeks before treatment start\n* Uncontrolled high blood pressure (>150/100mhHg)\n* Grade >/=2 heart rate disorder, atrial fibrillation whichever the grade, lengthen of QTC >450 msec for male or >470 msec for female.\n* Patients HIV positive\n* Pregnant or breastfeeding woman\n* Patients with psychiatric disorder\n* Active alcoholism\n* Previous pulmonary interstitial disease\n* Previous hypersensitivity to antihistamine treatment and/or medical contraindication for an antihistamine or corticoid treatment",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Patients with malignant tumor confirmed histologically or cytologically who does not respond to usual therapeutics or for whom there is no curative treatment",
"criterions": [
{
"exact_snippets": "malignant tumor confirmed histologically or cytologically",
"criterion": "malignant tumor",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": [
"histologically",
"cytologically"
]
}
},
{
"exact_snippets": "does not respond to usual therapeutics",
"criterion": "response to usual therapeutics",
"requirement": {
"requirement_type": "response",
"expected_value": false
}
},
{
"exact_snippets": "no curative treatment",
"criterion": "availability of curative treatment",
"requirement": {
"requirement_type": "availability",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "malignant tumor confirmed histologically or cytologically",
"criterion": "malignant tumor",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": [
"histologically",
"cytologically"
]
}
},
{
"exact_snippets": "does not respond to usual therapeutics",
"criterion": "response to usual therapeutics",
"requirement": {
"requirement_type": "response",
"expected_value": false
}
}
]
},
{
"exact_snippets": "no curative treatment",
"criterion": "availability of curative treatment",
"requirement": {
"requirement_type": "availability",
"expected_value": false
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Age >/= 18 years",
"criterions": [
{
"exact_snippets": "Age >/= 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age >/= 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Life expectancy >/= 12 weeks",
"criterions": [
{
"exact_snippets": "Life expectancy >/= 12 weeks",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 12,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Life expectancy >/= 12 weeks",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 12,
"unit": "weeks"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Grade </=1 for all adverse effects related to previous therapy or surgery (except for alopecia)",
"criterions": [
{
"exact_snippets": "Grade </=1 for all adverse effects related to previous therapy or surgery",
"criterion": "adverse effects related to previous therapy or surgery",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "Grade"
}
}
},
{
"exact_snippets": "except for alopecia",
"criterion": "alopecia",
"requirement": {
"requirement_type": "exclusion",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Grade </=1 for all adverse effects related to previous therapy or surgery",
"criterion": "adverse effects related to previous therapy or surgery",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "Grade"
}
}
},
{
"not_criteria": {
"exact_snippets": "except for alopecia",
"criterion": "alopecia",
"requirement": {
"requirement_type": "exclusion",
"expected_value": true
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Appropriate organic functions as defined:",
"criterions": [
{
"exact_snippets": "Appropriate organic functions",
"criterion": "organic functions",
"requirement": {
"requirement_type": "appropriateness",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "Appropriate organic functions",
"criterion": "organic functions",
"requirement": {
"requirement_type": "appropriateness",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* ASAT and ALAT </= 2.5xLSN or ASAT and ALAT </= 5xLSN in case of inappropriate hepatic function due to the underlying disease",
"criterions": [
{
"exact_snippets": "ASAT and ALAT </= 2.5xLSN",
"criterion": "ASAT and ALAT levels",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": "<=",
"value": 2.5,
"unit": "xLSN"
}
}
},
{
"exact_snippets": "ASAT and ALAT </= 5xLSN in case of inappropriate hepatic function due to the underlying disease",
"criterion": "ASAT and ALAT levels in case of inappropriate hepatic function due to the underlying disease",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": "<=",
"value": 5,
"unit": "xLSN"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "ASAT and ALAT </= 2.5xLSN",
"criterion": "ASAT and ALAT levels",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": "<=",
"value": 2.5,
"unit": "xLSN"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "ASAT and ALAT </= 5xLSN in case of inappropriate hepatic function due to the underlying disease",
"criterion": "ASAT and ALAT levels in case of inappropriate hepatic function due to the underlying disease",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": "<=",
"value": 5,
"unit": "xLSN"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Bilirubin </= 1.5xLSN",
"criterions": [
{
"exact_snippets": "Bilirubin </= 1.5xLSN",
"criterion": "bilirubin level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 1.5,
"unit": "xLSN"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Bilirubin </= 1.5xLSN",
"criterion": "bilirubin level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 1.5,
"unit": "xLSN"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Albumin >/= 3.0 g/dL",
"criterions": [
{
"exact_snippets": "Albumin >/= 3.0 g/dL",
"criterion": "albumin level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 3.0,
"unit": "g/dL"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Albumin >/= 3.0 g/dL",
"criterion": "albumin level",
"requirement": {
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"operator": ">=",
"value": 3.0,
"unit": "g/dL"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Neutrophil counts (PNN) >/= 1 500/mL",
"criterions": [
{
"exact_snippets": "Neutrophil counts (PNN) >/= 1 500/mL",
"criterion": "neutrophil counts",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1500,
"unit": "mL"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Neutrophil counts (PNN) >/= 1 500/mL",
"criterion": "neutrophil counts",
"requirement": {
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"expected_value": {
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{
"operator": ">=",
"value": 1500,
"unit": "mL"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Platelets >/= 100 000/mL",
"criterions": [
{
"exact_snippets": "Platelets >/= 100 000/mL",
"criterion": "platelet count",
"requirement": {
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{
"operator": ">=",
"value": 100000,
"unit": "mL"
}
]
}
}
}
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"and_criteria": [
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"exact_snippets": "Platelets >/= 100 000/mL",
"criterion": "platelet count",
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{
"operator": ">=",
"value": 100000,
"unit": "mL"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Hemoglobin >/= 9.0 g/dL",
"criterions": [
{
"exact_snippets": "Hemoglobin >/= 9.0 g/dL",
"criterion": "hemoglobin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 9.0,
"unit": "g/dL"
}
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Hemoglobin >/= 9.0 g/dL",
"criterion": "hemoglobin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 9.0,
"unit": "g/dL"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Creatinin </= 1.5xLSN",
"criterions": [
{
"exact_snippets": "Creatinin </= 1.5xLSN",
"criterion": "creatinine level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "xLSN"
}
}
}
]
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"logical_structure": {
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{
"exact_snippets": "Creatinin </= 1.5xLSN",
"criterion": "creatinine level",
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"operator": "<=",
"value": 1.5,
"unit": "xLSN"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Cooperative patients able to respect the protocol",
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{
"exact_snippets": "Cooperative patients",
"criterion": "patient cooperation",
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"expected_value": true
}
},
{
"exact_snippets": "able to respect the protocol",
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"requirement": {
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"expected_value": true
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}
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"and_criteria": [
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"exact_snippets": "Cooperative patients",
"criterion": "patient cooperation",
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"expected_value": true
}
},
{
"exact_snippets": "able to respect the protocol",
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"requirement": {
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"expected_value": true
}
}
]
}
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"identified_line": {
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"exact_snippets": "Healthy volunteers allowed",
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}
}
]
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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": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
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"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Treatment by chemotherapy, radiotherapy, surgery or the two compounds of the study within 4 weeks before the inclusion",
"criterions": [
{
"exact_snippets": "Treatment by chemotherapy ... within 4 weeks before the inclusion",
"criterion": "chemotherapy treatment",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
},
{
"exact_snippets": "Treatment by ... radiotherapy ... within 4 weeks before the inclusion",
"criterion": "radiotherapy treatment",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
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{
"exact_snippets": "Treatment by ... surgery ... within 4 weeks before the inclusion",
"criterion": "surgery",
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"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
},
{
"exact_snippets": "Treatment by ... the two compounds of the study within 4 weeks before the inclusion",
"criterion": "treatment with the two compounds of the study",
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"operator": ">=",
"value": 4,
"unit": "weeks"
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}
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"and_criteria": [
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"exact_snippets": "Treatment by chemotherapy ... within 4 weeks before the inclusion",
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"unit": "weeks"
}
}
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"and_criteria": [
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"exact_snippets": "Treatment by ... radiotherapy ... within 4 weeks before the inclusion",
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"expected_value": {
"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
}
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{
"and_criteria": [
{
"exact_snippets": "Treatment by ... surgery ... within 4 weeks before the inclusion",
"criterion": "surgery",
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"unit": "weeks"
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"and_criteria": [
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},
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"identified_line": {
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{
"exact_snippets": "Previous treatment with an association of mTOR inhibitor",
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"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Previous treatment with an association of ... EGFR inhibitor",
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"expected_value": true
}
}
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"exact_snippets": "Previous treatment with an association of mTOR inhibitor",
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"expected_value": true
}
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"exact_snippets": "Previous treatment with an association of ... EGFR inhibitor",
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}
}
]
}
},
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"exact_snippets": "Grade >/= 2 nephropathy according to NCI CTCAE",
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}
},
{
"exact_snippets": "Current treatment with curative dose of ... heparin of low molecular weight",
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}
},
{
"exact_snippets": "Current treatment with curative dose of ... heparin of low molecular weight",
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"and_criteria": [
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"and_criteria": [
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"exact_snippets": "Current treatment with curative dose of ... heparin of low molecular weight",
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{
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"expected_value": false
}
},
{
"exact_snippets": "medullar compression",
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"expected_value": true
}
},
{
"exact_snippets": "carcinomatosis meningitis",
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"expected_value": true
}
},
{
"exact_snippets": "proof of leptomeningeal pathology",
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"requirement": {
"requirement_type": "proof",
"expected_value": true
}
},
{
"exact_snippets": "proof of ... metastasis",
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"requirement": {
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"expected_value": true
}
}
]
},
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{
"and_criteria": [
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"exact_snippets": "uncontrolled brain metastases",
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"expected_value": false
}
},
{
"exact_snippets": "medullar compression",
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}
},
{
"exact_snippets": "carcinomatosis meningitis",
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}
}
]
},
{
"exact_snippets": "proof of leptomeningeal pathology",
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}
},
{
"exact_snippets": "proof of ... metastasis",
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* myocardial infarction",
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{
"exact_snippets": "myocardial infarction",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "myocardial infarction",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* angina pectoris",
"criterions": [
{
"exact_snippets": "angina pectoris",
"criterion": "angina pectoris",
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"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "angina pectoris",
"criterion": "angina pectoris",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* bypass of coronal or peripheral arteries",
"criterions": [
{
"exact_snippets": "bypass of coronal or peripheral arteries",
"criterion": "bypass surgery",
"requirement": {
"requirement_type": "location",
"expected_value": [
"coronal arteries",
"peripheral arteries"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "bypass of coronal or peripheral arteries",
"criterion": "bypass surgery",
"requirement": {
"requirement_type": "location",
"expected_value": [
"coronal arteries",
"peripheral arteries"
]
}
}
]
}
},
{
"identified_line": {
"line": "* heart failure",
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{
"exact_snippets": "heart failure",
"criterion": "heart failure",
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"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "heart failure",
"criterion": "heart failure",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* stroke",
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{
"exact_snippets": "stroke",
"criterion": "stroke",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "stroke",
"criterion": "stroke",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* cerebral bleeding",
"criterions": [
{
"exact_snippets": "cerebral bleeding",
"criterion": "cerebral bleeding",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "cerebral bleeding",
"criterion": "cerebral bleeding",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* pulmonary embolism",
"criterions": [
{
"exact_snippets": "pulmonary embolism",
"criterion": "pulmonary embolism",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "pulmonary embolism",
"criterion": "pulmonary embolism",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Grade 3 bleeding according to NCI CTCAE criteria less than 3 weeks before treatment start",
"criterions": [
{
"exact_snippets": "Grade 3 bleeding according to NCI CTCAE criteria",
"criterion": "bleeding",
"requirement": {
"requirement_type": "severity",
"expected_value": "Grade 3"
}
},
{
"exact_snippets": "Grade 3 bleeding according to NCI CTCAE criteria",
"criterion": "bleeding",
"requirement": {
"requirement_type": "standard",
"expected_value": "NCI CTCAE"
}
},
{
"exact_snippets": "less than 3 weeks before treatment start",
"criterion": "time since bleeding",
"requirement": {
"requirement_type": "time since event",
"expected_value": {
"operator": "<",
"value": 3,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Grade 3 bleeding according to NCI CTCAE criteria",
"criterion": "bleeding",
"requirement": {
"requirement_type": "severity",
"expected_value": "Grade 3"
}
},
{
"exact_snippets": "Grade 3 bleeding according to NCI CTCAE criteria",
"criterion": "bleeding",
"requirement": {
"requirement_type": "standard",
"expected_value": "NCI CTCAE"
}
}
]
},
{
"exact_snippets": "less than 3 weeks before treatment start",
"criterion": "time since bleeding",
"requirement": {
"requirement_type": "time since event",
"expected_value": {
"operator": "<",
"value": 3,
"unit": "weeks"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Uncontrolled high blood pressure (>150/100mhHg)",
"criterions": [
{
"exact_snippets": "Uncontrolled high blood pressure (>150/100mhHg)",
"criterion": "blood pressure",
"requirement": {
"requirement_type": "control",
"expected_value": false
}
},
{
"exact_snippets": "Uncontrolled high blood pressure (>150/100mhHg)",
"criterion": "blood pressure",
"requirement": {
"requirement_type": "systolic",
"expected_value": {
"operator": ">",
"value": 150,
"unit": "mmHg"
}
}
},
{
"exact_snippets": "Uncontrolled high blood pressure (>150/100mhHg)",
"criterion": "blood pressure",
"requirement": {
"requirement_type": "diastolic",
"expected_value": {
"operator": ">",
"value": 100,
"unit": "mmHg"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Uncontrolled high blood pressure (>150/100mhHg)",
"criterion": "blood pressure",
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"requirement_type": "systolic",
"expected_value": {
"operator": ">",
"value": 150,
"unit": "mmHg"
}
}
},
{
"exact_snippets": "Uncontrolled high blood pressure (>150/100mhHg)",
"criterion": "blood pressure",
"requirement": {
"requirement_type": "diastolic",
"expected_value": {
"operator": ">",
"value": 100,
"unit": "mmHg"
}
}
}
]
},
{
"exact_snippets": "Uncontrolled high blood pressure (>150/100mhHg)",
"criterion": "blood pressure",
"requirement": {
"requirement_type": "control",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Grade >/=2 heart rate disorder, atrial fibrillation whichever the grade, lengthen of QTC >450 msec for male or >470 msec for female.",
"criterions": [
{
"exact_snippets": "Grade >/=2 heart rate disorder",
"criterion": "heart rate disorder",
"requirement": {
"requirement_type": "grade",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "N/A"
}
}
},
{
"exact_snippets": "atrial fibrillation whichever the grade",
"criterion": "atrial fibrillation",
"requirement": {
"requirement_type": "grade",
"expected_value": "any"
}
},
{
"exact_snippets": "lengthen of QTC >450 msec for male",
"criterion": "QTC interval",
"requirement": {
"requirement_type": "length",
"expected_value": {
"operator": ">",
"value": 450,
"unit": "msec"
}
}
},
{
"exact_snippets": "lengthen of QTC >450 msec for male",
"criterion": "QTC interval",
"requirement": {
"requirement_type": "gender",
"expected_value": "male"
}
},
{
"exact_snippets": "lengthen of QTC ... >470 msec for female",
"criterion": "QTC interval",
"requirement": {
"requirement_type": "length",
"expected_value": {
"operator": ">",
"value": 470,
"unit": "msec"
}
}
},
{
"exact_snippets": "lengthen of QTC ... >470 msec for female",
"criterion": "QTC interval",
"requirement": {
"requirement_type": "gender",
"expected_value": "female"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Grade >/=2 heart rate disorder",
"criterion": "heart rate disorder",
"requirement": {
"requirement_type": "grade",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "N/A"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "atrial fibrillation whichever the grade",
"criterion": "atrial fibrillation",
"requirement": {
"requirement_type": "grade",
"expected_value": "any"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "lengthen of QTC >450 msec for male",
"criterion": "QTC interval",
"requirement": {
"requirement_type": "length",
"expected_value": {
"operator": ">",
"value": 450,
"unit": "msec"
}
}
},
{
"exact_snippets": "lengthen of QTC >450 msec for male",
"criterion": "QTC interval",
"requirement": {
"requirement_type": "gender",
"expected_value": "male"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "lengthen of QTC ... >470 msec for female",
"criterion": "QTC interval",
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"requirement_type": "length",
"expected_value": {
"operator": ">",
"value": 470,
"unit": "msec"
}
}
},
{
"exact_snippets": "lengthen of QTC ... >470 msec for female",
"criterion": "QTC interval",
"requirement": {
"requirement_type": "gender",
"expected_value": "female"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patients HIV positive",
"criterions": [
{
"exact_snippets": "Patients HIV positive",
"criterion": "HIV status",
"requirement": {
"requirement_type": "status",
"expected_value": "positive"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Patients HIV positive",
"criterion": "HIV status",
"requirement": {
"requirement_type": "status",
"expected_value": "positive"
}
}
}
},
{
"identified_line": {
"line": "* Patients with psychiatric disorder",
"criterions": [
{
"exact_snippets": "psychiatric disorder",
"criterion": "psychiatric disorder",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "psychiatric disorder",
"criterion": "psychiatric disorder",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Active alcoholism",
"criterions": [
{
"exact_snippets": "Active alcoholism",
"criterion": "alcoholism",
"requirement": {
"requirement_type": "status",
"expected_value": "active"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Active alcoholism",
"criterion": "alcoholism",
"requirement": {
"requirement_type": "status",
"expected_value": "active"
}
}
}
},
{
"identified_line": {
"line": "* Previous pulmonary interstitial disease",
"criterions": [
{
"exact_snippets": "Previous pulmonary interstitial disease",
"criterion": "pulmonary interstitial disease",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Previous pulmonary interstitial disease",
"criterion": "pulmonary interstitial disease",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Previous hypersensitivity to antihistamine treatment and/or medical contraindication for an antihistamine or corticoid treatment",
"criterions": [
{
"exact_snippets": "Previous hypersensitivity to antihistamine treatment",
"criterion": "hypersensitivity to antihistamine treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "medical contraindication for an antihistamine",
"criterion": "contraindication for antihistamine treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "medical contraindication for ... corticoid treatment",
"criterion": "contraindication for corticoid treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Previous hypersensitivity to antihistamine treatment",
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"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "medical contraindication for an antihistamine",
"criterion": "contraindication for antihistamine treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"exact_snippets": "medical contraindication for ... corticoid treatment",
"criterion": "contraindication for corticoid treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Presence of one og those pathologies during the last 12 months before the inclusion:",
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{
"exact_snippets": "Presence of one of those pathologies during the last 12 months before the inclusion",
"criterion": "pathologies",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Presence of one of those pathologies during the last 12 months before the inclusion",
"criterion": "pathologies",
"requirement": {
"requirement_type": "time frame",
"expected_value": "last 12 months before the inclusion"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Presence of one of those pathologies during the last 12 months before the inclusion",
"criterion": "pathologies",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Presence of one of those pathologies during the last 12 months before the inclusion",
"criterion": "pathologies",
"requirement": {
"requirement_type": "time frame",
"expected_value": "last 12 months before the inclusion"
}
}
]
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* ECOG 0 or 1",
"criterions": [
{
"exact_snippets": "ECOG 0 or 1",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "value",
"expected_value": [
"0",
"1"
]
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "ECOG 0 or 1",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "value",
"expected_value": "0"
}
},
{
"exact_snippets": "ECOG 0 or 1",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "value",
"expected_value": "1"
}
}
]
}
}
],
"failed_exclusion": [
{
"identified_line": {
"line": "* Diagnosis of a secondary cancer within the last 3 years except for a basal-cell carcinoma, cutaneous spinocellular cancer or in situ carcinoma well treated",
"criterions": [
{
"exact_snippets": "Diagnosis of a secondary cancer within the last 3 years",
"criterion": "secondary cancer diagnosis",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 3,
"unit": "years"
}
]
}
}
},
{
"exact_snippets": "except for a basal-cell carcinoma",
"criterion": "basal-cell carcinoma",
"requirement": {
"requirement_type": "exclusion",
"expected_value": true
}
},
{
"exact_snippets": "cutaneous spinocellular cancer",
"criterion": "cutaneous spinocellular cancer",
"requirement": {
"requirement_type": "exclusion",
"expected_value": true
}
},
{
"exact_snippets": "in situ carcinoma well treated",
"criterion": "in situ carcinoma",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "well treated"
}
},
{
"exact_snippets": "in situ carcinoma well treated",
"criterion": "in situ carcinoma",
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"requirement_type": "exclusion",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Pregnant or breastfeeding woman",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "breastfeeding",
"criterion": "breastfeeding",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "breastfeeding",
"criterion": "breastfeeding",
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"requirement_type": "presence",
"expected_value": true
}
}
]
}
}
],
"failed_miscellaneous": []
}