{
"info": {
"nct_id": "NCT02159248",
"official_title": "09.017 - A Phase I Study of Tolfenamic Acid With Gemcitabine and Radiation in Patients With Locally Advanced or Metastatic Pancreatic Cancer Requiring Definitive or Palliative Radiation Therapy",
"inclusion_criteria": "1. Patients must have histologically or cytologically confirmed:\n\n 1. Locally advanced (potentially resectable) pancreatic adenocarcinoma requiring neoadjuvant radiation or\n 2. Locally advanced (nonresectable) or metastatic pancreatic adenocarcinoma requiring definitive or palliative radiation therapy\n2. Patients may have either measurable or non-measurable disease (according to RECIST criteria, Version 1.1).\n3. Age ≥ 18 years\n4. ECOG performance status of 0 or 1.\n5. A life expectancy of at least 12 weeks.\n6. No other concurrent radiotherapy, chemotherapy or immunotherapy.\n7. A minimum of 4 weeks must have elapsed since completion of any prior chemotherapy or immunotherapy.\n8. Patient must have:\n\n 1. Absolute neutrophil count (ANC) ≥1,000/mm3\n 2. Platelets ≥100,000/mm3\n 3. Hemoglobin ≥10 g/dL [Transfusion to meet the hemoglobin requirement is acceptable]\n 4. Serum creatinine ≤ 1.5 X ULN\n 5. Total bilirubin ≤ 1.5 X ULN\n 6. Aspartate aminotransferase (AST) ≤ 2.5 X ULN\n 7. Alanine aminotransferase (ALT) ≤ 2.5 X ULN\n 8. Alkaline phosphatase ≤ 2.5 X ULN\n 9. PT/INR ≤ 1.5 X ULN\n 10. aPTT ≤ 1.5 X ULN\n 11. Urine Protein ≤ Grade 1\n9. For patients on warfarin: Must have maintained a stable INR on a stable dose of warfarin for at least 4 weeks prior to start of treatment.\n\nPrimary\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "1. Patients who have received prior radiation for their current malignancy at the location of interest.\n2. Patients who have not recovered (to Grade 1 or less) from adverse events, other than alopecia and neuropathy, caused by previously administered chemotherapeutic agents, at the discretion of the PI/treating physician.\n3. Tolfenamic acid use concurrent with, or within 8 weeks prior to the diagnosis of pancreatic cancer.\n4. Current use of any non-steroidal anti-inflammatory agents (NSAIDs), including aspirin, (other than tolfenamic acid) within 4 weeks prior to the start of active treatment.\n5. Previous history of hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin or other NSAIDs.\n6. History of recurrent peptic ulcer/hemorrhage (two or more distinct episodes).\n7. History of gastrointestinal bleeding or perforation related to previous use of NSAIDS.\n8. New York Heart Association Functional Classification of 3 or 4.\n9. Known autoimmune disease that could preclude the use of radiation, at the discretion of the treating physician.\n10. History or evidence of CNS disease (e.g., any brain metastases, primary brain tumor, seizures not controlled with standard medical therapy, or history of stroke).\n11. Known HIV positive.\n12. Active systemic infection requiring parenteral antibiotic therapy.\n13. Receiving systemic steroid therapy. (Inhaled steroid therapy is allowable.)\n14. History of other malignancies within the last 5 years with the exception of non- melanoma skin cancer or cervical cancer in situ that has been successfully treated.",
"miscellaneous_criteria": "Primary"
},
"inclusion_lines": [
{
"identified_line": {
"line": "1. Patients must have histologically or cytologically confirmed:",
"criterions": [
{
"exact_snippets": "histologically or cytologically confirmed",
"criterion": "cancer diagnosis confirmation",
"requirement": {
"requirement_type": "method",
"expected_value": [
"histologically",
"cytologically"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "histologically or cytologically confirmed",
"criterion": "cancer diagnosis confirmation",
"requirement": {
"requirement_type": "method",
"expected_value": [
"histologically",
"cytologically"
]
}
}
]
}
},
{
"identified_line": {
"line": "1. Locally advanced (potentially resectable) pancreatic adenocarcinoma requiring neoadjuvant radiation or",
"criterions": [
{
"exact_snippets": "Locally advanced (potentially resectable) pancreatic adenocarcinoma",
"criterion": "pancreatic adenocarcinoma",
"requirement": {
"requirement_type": "stage",
"expected_value": "locally advanced"
}
},
{
"exact_snippets": "Locally advanced (potentially resectable) pancreatic adenocarcinoma",
"criterion": "pancreatic adenocarcinoma",
"requirement": {
"requirement_type": "resectability",
"expected_value": "potentially resectable"
}
},
{
"exact_snippets": "requiring neoadjuvant radiation",
"criterion": "neoadjuvant radiation",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Locally advanced (potentially resectable) pancreatic adenocarcinoma",
"criterion": "pancreatic adenocarcinoma",
"requirement": {
"requirement_type": "stage",
"expected_value": "locally advanced"
}
},
{
"exact_snippets": "Locally advanced (potentially resectable) pancreatic adenocarcinoma",
"criterion": "pancreatic adenocarcinoma",
"requirement": {
"requirement_type": "resectability",
"expected_value": "potentially resectable"
}
}
]
},
{
"exact_snippets": "requiring neoadjuvant radiation",
"criterion": "neoadjuvant radiation",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "3. Age ≥ 18 years",
"criterions": [
{
"exact_snippets": "Age ≥ 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age ≥ 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "4. ECOG performance status of 0 or 1.",
"criterions": [
{
"exact_snippets": "ECOG performance status of 0 or 1",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "status",
"expected_value": [
"0",
"1"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "ECOG performance status of 0 or 1",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "status",
"expected_value": [
"0",
"1"
]
}
}
]
}
},
{
"identified_line": {
"line": "5. A life expectancy of at least 12 weeks.",
"criterions": [
{
"exact_snippets": "life expectancy of at least 12 weeks",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 12,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "life expectancy of at least 12 weeks",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 12,
"unit": "weeks"
}
}
}
]
}
},
{
"identified_line": {
"line": "6. No other concurrent radiotherapy, chemotherapy or immunotherapy.",
"criterions": [
{
"exact_snippets": "No other concurrent radiotherapy",
"criterion": "concurrent radiotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No other concurrent ... chemotherapy",
"criterion": "concurrent chemotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No other concurrent ... immunotherapy",
"criterion": "concurrent immunotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "No other concurrent radiotherapy",
"criterion": "concurrent radiotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No other concurrent ... chemotherapy",
"criterion": "concurrent chemotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"exact_snippets": "No other concurrent ... immunotherapy",
"criterion": "concurrent immunotherapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "7. A minimum of 4 weeks must have elapsed since completion of any prior chemotherapy or immunotherapy.",
"criterions": [
{
"exact_snippets": "A minimum of 4 weeks must have elapsed since completion of any prior chemotherapy",
"criterion": "elapsed time since prior chemotherapy",
"requirement": {
"requirement_type": "time elapsed",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
},
{
"exact_snippets": "A minimum of 4 weeks must have elapsed since completion of any prior ... immunotherapy",
"criterion": "elapsed time since prior immunotherapy",
"requirement": {
"requirement_type": "time elapsed",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "A minimum of 4 weeks must have elapsed since completion of any prior chemotherapy",
"criterion": "elapsed time since prior chemotherapy",
"requirement": {
"requirement_type": "time elapsed",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
},
{
"exact_snippets": "A minimum of 4 weeks must have elapsed since completion of any prior ... immunotherapy",
"criterion": "elapsed time since prior immunotherapy",
"requirement": {
"requirement_type": "time elapsed",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
}
]
}
},
{
"identified_line": {
"line": "1. Absolute neutrophil count (ANC) ≥1,000/mm3",
"criterions": [
{
"exact_snippets": "Absolute neutrophil count (ANC) ≥1,000/mm3",
"criterion": "absolute neutrophil count (ANC)",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1000,
"unit": "mm3"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Absolute neutrophil count (ANC) ≥1,000/mm3",
"criterion": "absolute neutrophil count (ANC)",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1000,
"unit": "mm3"
}
}
}
]
}
},
{
"identified_line": {
"line": "2. Platelets ≥100,000/mm3",
"criterions": [
{
"exact_snippets": "Platelets ≥100,000/mm3",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "mm3"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Platelets ≥100,000/mm3",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "mm3"
}
}
}
]
}
},
{
"identified_line": {
"line": "3. Hemoglobin ≥10 g/dL [Transfusion to meet the hemoglobin requirement is acceptable]",
"criterions": [
{
"exact_snippets": "Hemoglobin ≥10 g/dL",
"criterion": "hemoglobin level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 10,
"unit": "g/dL"
}
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "Transfusion to meet the hemoglobin requirement is acceptable",
"criterion": "transfusion",
"requirement": {
"requirement_type": "acceptability",
"expected_value": true
}
},
"then_criteria": {
"exact_snippets": "Hemoglobin ≥10 g/dL",
"criterion": "hemoglobin level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 10,
"unit": "g/dL"
}
}
},
"else_criteria": {
"exact_snippets": "Hemoglobin ≥10 g/dL",
"criterion": "hemoglobin level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 10,
"unit": "g/dL"
}
}
}
}
},
{
"identified_line": {
"line": "5. Total bilirubin ≤ 1.5 X ULN",
"criterions": [
{
"exact_snippets": "Total bilirubin ≤ 1.5 X ULN",
"criterion": "total bilirubin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "X ULN"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Total bilirubin ≤ 1.5 X ULN",
"criterion": "total bilirubin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "X ULN"
}
}
}
]
}
},
{
"identified_line": {
"line": "7. Alanine aminotransferase (ALT) ≤ 2.5 X ULN",
"criterions": [
{
"exact_snippets": "Alanine aminotransferase (ALT) ≤ 2.5 X ULN",
"criterion": "Alanine aminotransferase (ALT)",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 2.5,
"unit": "X ULN"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Alanine aminotransferase (ALT) ≤ 2.5 X ULN",
"criterion": "Alanine aminotransferase (ALT)",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 2.5,
"unit": "X ULN"
}
}
}
]
}
},
{
"identified_line": {
"line": "8. Alkaline phosphatase ≤ 2.5 X ULN",
"criterions": [
{
"exact_snippets": "Alkaline phosphatase ≤ 2.5 X ULN",
"criterion": "alkaline phosphatase",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 2.5,
"unit": "X ULN"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Alkaline phosphatase ≤ 2.5 X ULN",
"criterion": "alkaline phosphatase",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 2.5,
"unit": "X ULN"
}
}
}
]
}
},
{
"identified_line": {
"line": "10. aPTT ≤ 1.5 X ULN",
"criterions": [
{
"exact_snippets": "aPTT ≤ 1.5 X ULN",
"criterion": "aPTT",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "X ULN"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "aPTT ≤ 1.5 X ULN",
"criterion": "aPTT",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "X ULN"
}
}
}
]
}
},
{
"identified_line": {
"line": "11. Urine Protein ≤ Grade 1",
"criterions": [
{
"exact_snippets": "Urine Protein ≤ Grade 1",
"criterion": "urine protein",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "Grade"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Urine Protein ≤ Grade 1",
"criterion": "urine protein",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "Grade"
}
}
}
]
}
},
{
"identified_line": {
"line": "9. For patients on warfarin: Must have maintained a stable INR on a stable dose of warfarin for at least 4 weeks prior to start of treatment.",
"criterions": [
{
"exact_snippets": "patients on warfarin",
"criterion": "warfarin use",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "stable INR",
"criterion": "INR stability",
"requirement": {
"requirement_type": "stability",
"expected_value": true
}
},
{
"exact_snippets": "stable dose of warfarin",
"criterion": "warfarin dose stability",
"requirement": {
"requirement_type": "stability",
"expected_value": true
}
},
{
"exact_snippets": "at least 4 weeks prior to start of treatment",
"criterion": "duration of stability",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "patients on warfarin",
"criterion": "warfarin use",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
"then_criteria": {
"and_criteria": [
{
"exact_snippets": "stable INR",
"criterion": "INR stability",
"requirement": {
"requirement_type": "stability",
"expected_value": true
}
},
{
"exact_snippets": "stable dose of warfarin",
"criterion": "warfarin dose stability",
"requirement": {
"requirement_type": "stability",
"expected_value": true
}
},
{
"exact_snippets": "at least 4 weeks prior to start of treatment",
"criterion": "duration of stability",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
}
]
},
"else_criteria": null
}
},
{
"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": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"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": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "8. Patient must have:",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
},
{
"identified_line": {
"line": "Primary",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "1. Patients who have received prior radiation for their current malignancy at the location of interest.",
"criterions": [
{
"exact_snippets": "Patients who have received prior radiation for their current malignancy at the location of interest.",
"criterion": "prior radiation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Patients who have received prior radiation for their current malignancy at the location of interest.",
"criterion": "prior radiation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "2. Patients who have not recovered (to Grade 1 or less) from adverse events, other than alopecia and neuropathy, caused by previously administered chemotherapeutic agents, at the discretion of the PI/treating physician.",
"criterions": [
{
"exact_snippets": "Patients who have not recovered (to Grade 1 or less) from adverse events ... caused by previously administered chemotherapeutic agents",
"criterion": "recovery from adverse events",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "Grade"
}
}
},
{
"exact_snippets": "other than alopecia and neuropathy",
"criterion": "adverse events",
"requirement": {
"requirement_type": "exclusion",
"expected_value": [
"alopecia",
"neuropathy"
]
}
}
]
},
"logical_structure": {
"condition": {
"and_criteria": [
{
"not_criteria": {
"exact_snippets": "Patients who have not recovered (to Grade 1 or less) from adverse events ... caused by previously administered chemotherapeutic agents",
"criterion": "recovery from adverse events",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "Grade"
}
}
}
},
{
"not_criteria": {
"exact_snippets": "other than alopecia and neuropathy",
"criterion": "adverse events",
"requirement": {
"requirement_type": "exclusion",
"expected_value": [
"alopecia",
"neuropathy"
]
}
}
}
]
},
"then_criteria": {
"exact_snippets": "at the discretion of the PI/treating physician",
"criterion": "discretion of the PI/treating physician",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "3. Tolfenamic acid use concurrent with, or within 8 weeks prior to the diagnosis of pancreatic cancer.",
"criterions": [
{
"exact_snippets": "Tolfenamic acid use concurrent with, or within 8 weeks prior to the diagnosis of pancreatic cancer.",
"criterion": "Tolfenamic acid use",
"requirement": {
"requirement_type": "timing",
"expected_value": "concurrent with, or within 8 weeks prior to the diagnosis of pancreatic cancer"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Tolfenamic acid use concurrent with, or within 8 weeks prior to the diagnosis of pancreatic cancer.",
"criterion": "Tolfenamic acid use",
"requirement": {
"requirement_type": "timing",
"expected_value": "concurrent with, or within 8 weeks prior to the diagnosis of pancreatic cancer"
}
}
}
},
{
"identified_line": {
"line": "4. Current use of any non-steroidal anti-inflammatory agents (NSAIDs), including aspirin, (other than tolfenamic acid) within 4 weeks prior to the start of active treatment.",
"criterions": [
{
"exact_snippets": "Current use of any non-steroidal anti-inflammatory agents (NSAIDs), including aspirin, (other than tolfenamic acid) within 4 weeks prior to the start of active treatment.",
"criterion": "use of non-steroidal anti-inflammatory agents (NSAIDs)",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Current use of ... aspirin ... within 4 weeks prior to the start of active treatment.",
"criterion": "use of aspirin",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Current use of ... tolfenamic acid ... within 4 weeks prior to the start of active treatment.",
"criterion": "use of tolfenamic acid",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
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{
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"exact_snippets": "Current use of any non-steroidal anti-inflammatory agents (NSAIDs), including aspirin, (other than tolfenamic acid) within 4 weeks prior to the start of active treatment.",
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"requirement_type": "history",
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"exact_snippets": "History of recurrent peptic ulcer",
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"operator": ">=",
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"exact_snippets": "History of recurrent ... hemorrhage",
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}
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{
"and_criteria": [
{
"exact_snippets": "History of recurrent peptic ulcer",
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"exact_snippets": "History of recurrent peptic ulcer",
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"identified_line": {
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"exact_snippets": "New York Heart Association Functional Classification of 3 or 4",
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"requirement_type": "classification",
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"exact_snippets": "New York Heart Association Functional Classification of 3 or 4",
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"line": "9. Known autoimmune disease that could preclude the use of radiation, at the discretion of the treating physician.",
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"exact_snippets": "could preclude the use of radiation",
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"requirement_type": "preclusion",
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"exact_snippets": "could preclude the use of radiation",
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"identified_line": {
"line": "10. History or evidence of CNS disease (e.g., any brain metastases, primary brain tumor, seizures not controlled with standard medical therapy, or history of stroke).",
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"exact_snippets": "History or evidence of CNS disease ... brain metastases",
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"exact_snippets": "History or evidence of CNS disease ... primary brain tumor",
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"exact_snippets": "History or evidence of CNS disease ... seizures not controlled with standard medical therapy",
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}
},
{
"exact_snippets": "History or evidence of CNS disease ... history of stroke",
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"requirement_type": "presence",
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]
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"exact_snippets": "History or evidence of CNS disease ... brain metastases",
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},
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}
},
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"identified_line": {
"line": "11. Known HIV positive.",
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"exact_snippets": "Known HIV positive.",
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"requirement_type": "status",
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"exact_snippets": "Known HIV positive.",
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}
}
},
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"identified_line": {
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"exact_snippets": "Active systemic infection",
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"exact_snippets": "requiring parenteral antibiotic therapy",
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"operator": "<=",
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"exact_snippets": "Serum creatinine \u0010.5 X ULN",
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"operator": "<=",
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"exact_snippets": "Aspartate aminotransferase (AST) \u0010.5 X ULN",
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}
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],
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"exact_snippets": "hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria)",
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"exact_snippets": "in response to ibuprofen, aspirin or other NSAIDs",
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]
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],
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}