{
"info": {
"nct_id": "NCT00861120",
"official_title": "Panitumumab and Pegylated Liposomal Doxorubicin for Platinum-Resistant Epithelial Ovarian Cancer With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-type",
"inclusion_criteria": "* Histologically confirmed epithelial primary ovarian, primary fallopian or primary peritoneal cancer. Stage I-IV.\n\n * A: First line treatment with a platinum containing regimen with either progression or no response during 1.line chemotherapy, or relapse within 6 months after end of 1. line chemotherapy, OR\n * B: Patients receiving second line with a platinum containing regimen with either progression or no response during second line chemotherapy, or relapse within 6 months after end of second line chemotherapy\n* Maximum two prior lines of chemotherapy (both platinum-based)\n* Age ≥ 18 years.\n* Performance status 0-2.\n* Measurable disease by CA125 GCIG criteria\n* KRAS wild type\n* Adequate bone marrow function, liver function, renal function and coagulation parameters (within 7 days prior to randomization):\n\n * WBC ≥ 3.0 x 109/l or neutrophils (ANC)≥ 1.5 x 109/l\n * Platelet count ≥ 100 x 109/l\n * Hemoglobin ≥ 9.7 g/dl (6 mmol/L)\n * Serum bilirubin ≤ 1.5 x UNL\n * Serum transaminases ≤ 2.5 x UNL in absence of liver metastases, or ≤ 5xUNL in presence of liver metastases\n * Serum creatinine ≤ 1.5 x UNL\n * Magnesium ≥ lower limit of normal\n * Calcium ≥ lower limit of normal\n* Written informed consent\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Prior treatment with chemotherapy or biological targeted treatment except 1. line chemotherapy with platinum or combination platinum/taxane (bevacizumab allowed as part of the 1. line treatment).\n* Patients who have received (or are planning to receive) treatment with any other investigational agent, or who have participated in another clinical trial within 28 days prior to entering this trial.\n* Pregnant or breast-feeding or planning to become pregnant within 6 months after end of treatment. For fertile women a negative pregnancy test at screening is mandatory.\n* Fertile patients not willing to use acceptable and safe methods of contraception during and for 6 months following treatment\n* Other present or previous malignancy except curatively treated cervical cancer, non-melanotic skin cancer or other cancer with minimal risk of relapse.\n* CNS metastasis\n* History of any chronic medical or psychiatric condition or laboratory abnormality that are not medically controlled or in the opinion of the Investigator may increase the risks associated with study drug administration. (e.g. diabetes, cardiac diseases, hypertension).\n* Clinically significant cardiovascular disease ≤ 1 year before enrollment/randomization, including:\n\n * Myocardial infarction or unstable angina within 6 months of randomization.\n * New York Heart Association (NYHA) ≥ Grade 2 congestive heart failure. Even if medically controlled.\n * Poorly controlled cardiac arrhythmia despite Medication (patients with rate-controlled atrial fibrillation are eligible)\n* Uncontrolled hypercalcemia (calcium level outside the upper limit of normal; antihypercalcemic treatment is allowed).\n* Allergy to the ingredients of the study medication or to Staphylococcus Protein A\n* History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Histologically confirmed epithelial primary ovarian, primary fallopian or primary peritoneal cancer. Stage I-IV.",
"criterions": [
{
"exact_snippets": "Histologically confirmed epithelial primary ovarian, primary fallopian or primary peritoneal cancer.",
"criterion": "cancer type",
"requirement": {
"requirement_type": "presence",
"expected_value": [
"epithelial primary ovarian",
"primary fallopian",
"primary peritoneal"
]
}
},
{
"exact_snippets": "Stage I-IV.",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "Stage"
},
{
"operator": "<=",
"value": 4,
"unit": "Stage"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Histologically confirmed epithelial primary ovarian, primary fallopian or primary peritoneal cancer.",
"criterion": "cancer type",
"requirement": {
"requirement_type": "presence",
"expected_value": [
"epithelial primary ovarian",
"primary fallopian",
"primary peritoneal"
]
}
},
{
"exact_snippets": "Stage I-IV.",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "Stage"
},
{
"operator": "<=",
"value": 4,
"unit": "Stage"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* A: First line treatment with a platinum containing regimen with either progression or no response during 1.line chemotherapy, or relapse within 6 months after end of 1. line chemotherapy, OR",
"criterions": [
{
"exact_snippets": "First line treatment with a platinum containing regimen",
"criterion": "first line treatment",
"requirement": {
"requirement_type": "treatment type",
"expected_value": "platinum containing regimen"
}
},
{
"exact_snippets": "progression or no response during 1.line chemotherapy",
"criterion": "response to first line chemotherapy",
"requirement": {
"requirement_type": "response",
"expected_value": [
"progression",
"no response"
]
}
},
{
"exact_snippets": "relapse within 6 months after end of 1. line chemotherapy",
"criterion": "relapse after first line chemotherapy",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "First line treatment with a platinum containing regimen",
"criterion": "first line treatment",
"requirement": {
"requirement_type": "treatment type",
"expected_value": "platinum containing regimen"
}
},
{
"exact_snippets": "progression or no response during 1.line chemotherapy",
"criterion": "response to first line chemotherapy",
"requirement": {
"requirement_type": "response",
"expected_value": [
"progression",
"no response"
]
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "First line treatment with a platinum containing regimen",
"criterion": "first line treatment",
"requirement": {
"requirement_type": "treatment type",
"expected_value": "platinum containing regimen"
}
},
{
"exact_snippets": "relapse within 6 months after end of 1. line chemotherapy",
"criterion": "relapse after first line chemotherapy",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* B: Patients receiving second line with a platinum containing regimen with either progression or no response during second line chemotherapy, or relapse within 6 months after end of second line chemotherapy",
"criterions": [
{
"exact_snippets": "Patients receiving second line with a platinum containing regimen",
"criterion": "second line platinum containing regimen",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "progression or no response during second line chemotherapy",
"criterion": "response to second line chemotherapy",
"requirement": {
"requirement_type": "response",
"expected_value": [
"progression",
"no response"
]
}
},
{
"exact_snippets": "relapse within 6 months after end of second line chemotherapy",
"criterion": "relapse after second line chemotherapy",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patients receiving second line with a platinum containing regimen",
"criterion": "second line platinum containing regimen",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "progression or no response during second line chemotherapy",
"criterion": "response to second line chemotherapy",
"requirement": {
"requirement_type": "response",
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"progression",
"no response"
]
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Patients receiving second line with a platinum containing regimen",
"criterion": "second line platinum containing regimen",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "relapse within 6 months after end of second line chemotherapy",
"criterion": "relapse after second line chemotherapy",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Maximum two prior lines of chemotherapy (both platinum-based)",
"criterions": [
{
"exact_snippets": "Maximum two prior lines of chemotherapy",
"criterion": "prior lines of chemotherapy",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "lines"
}
}
},
{
"exact_snippets": "both platinum-based",
"criterion": "prior chemotherapy type",
"requirement": {
"requirement_type": "type",
"expected_value": "platinum-based"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Maximum two prior lines of chemotherapy",
"criterion": "prior lines of chemotherapy",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "lines"
}
}
},
{
"exact_snippets": "both platinum-based",
"criterion": "prior chemotherapy type",
"requirement": {
"requirement_type": "type",
"expected_value": "platinum-based"
}
}
]
}
},
{
"identified_line": {
"line": "* 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": "* Performance status 0-2.",
"criterions": [
{
"exact_snippets": "Performance status 0-2",
"criterion": "performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Performance status 0-2",
"criterion": "performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Measurable disease by CA125 GCIG criteria",
"criterions": [
{
"exact_snippets": "Measurable disease by CA125 GCIG criteria",
"criterion": "measurable disease",
"requirement": {
"requirement_type": "criteria",
"expected_value": "CA125 GCIG"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Measurable disease by CA125 GCIG criteria",
"criterion": "measurable disease",
"requirement": {
"requirement_type": "criteria",
"expected_value": "CA125 GCIG"
}
}
]
}
},
{
"identified_line": {
"line": "* KRAS wild type",
"criterions": [
{
"exact_snippets": "KRAS wild type",
"criterion": "KRAS",
"requirement": {
"requirement_type": "mutation status",
"expected_value": "wild type"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "KRAS wild type",
"criterion": "KRAS",
"requirement": {
"requirement_type": "mutation status",
"expected_value": "wild type"
}
}
]
}
},
{
"identified_line": {
"line": "* WBC ≥ 3.0 x 109/l or neutrophils (ANC)≥ 1.5 x 109/l",
"criterions": [
{
"exact_snippets": "WBC ≥ 3.0 x 109/l",
"criterion": "WBC",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 3.0,
"unit": "x 109/l"
}
}
},
{
"exact_snippets": "neutrophils (ANC)≥ 1.5 x 109/l",
"criterion": "neutrophils (ANC)",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1.5,
"unit": "x 109/l"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "WBC ≥ 3.0 x 109/l",
"criterion": "WBC",
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"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 3.0,
"unit": "x 109/l"
}
}
},
{
"exact_snippets": "neutrophils (ANC)≥ 1.5 x 109/l",
"criterion": "neutrophils (ANC)",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1.5,
"unit": "x 109/l"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Platelet count ≥ 100 x 109/l",
"criterions": [
{
"exact_snippets": "Platelet count ≥ 100 x 109/l",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100,
"unit": "x 109/l"
}
}
}
]
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"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Platelet count ≥ 100 x 109/l",
"criterion": "platelet count",
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"expected_value": {
"operator": ">=",
"value": 100,
"unit": "x 109/l"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Hemoglobin ≥ 9.7 g/dl (6 mmol/L)",
"criterions": [
{
"exact_snippets": "Hemoglobin ≥ 9.7 g/dl (6 mmol/L)",
"criterion": "hemoglobin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 9.7,
"unit": "g/dl"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Hemoglobin ≥ 9.7 g/dl (6 mmol/L)",
"criterion": "hemoglobin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 9.7,
"unit": "g/dl"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Serum bilirubin ≤ 1.5 x UNL",
"criterions": [
{
"exact_snippets": "Serum bilirubin ≤ 1.5 x UNL",
"criterion": "serum bilirubin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "x UNL"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "Serum bilirubin ≤ 1.5 x UNL",
"criterion": "serum bilirubin",
"requirement": {
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"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "x UNL"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Serum transaminases ≤ 2.5 x UNL in absence of liver metastases, or ≤ 5xUNL in presence of liver metastases",
"criterions": [
{
"exact_snippets": "Serum transaminases ≤ 2.5 x UNL in absence of liver metastases",
"criterion": "serum transaminases",
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"operator": "<=",
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}
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}
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"exact_snippets": "Serum transaminases ≤ 2.5 x UNL in absence of liver metastases",
"criterion": "serum transaminases",
"requirement": {
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"expected_value": "absence of liver metastases"
}
},
{
"exact_snippets": "Serum transaminases ... ≤ 5xUNL in presence of liver metastases",
"criterion": "serum transaminases",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"comparisons": [
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"operator": "<=",
"value": 5,
"unit": "x UNL"
}
]
}
}
},
{
"exact_snippets": "Serum transaminases ... ≤ 5xUNL in presence of liver metastases",
"criterion": "serum transaminases",
"requirement": {
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"expected_value": "presence of liver metastases"
}
}
]
},
"logical_structure": {
"xor_criteria": [
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"condition": {
"exact_snippets": "Serum transaminases ≤ 2.5 x UNL in absence of liver metastases",
"criterion": "serum transaminases",
"requirement": {
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"expected_value": "absence of liver metastases"
}
},
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"exact_snippets": "Serum transaminases ≤ 2.5 x UNL in absence of liver metastases",
"criterion": "serum transaminases",
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"operator": "<=",
"value": 2.5,
"unit": "x UNL"
}
]
}
}
},
"else_criteria": null
},
{
"condition": {
"exact_snippets": "Serum transaminases ... ≤ 5xUNL in presence of liver metastases",
"criterion": "serum transaminases",
"requirement": {
"requirement_type": "condition",
"expected_value": "presence of liver metastases"
}
},
"then_criteria": {
"exact_snippets": "Serum transaminases ... ≤ 5xUNL in presence of liver metastases",
"criterion": "serum transaminases",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"comparisons": [
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"operator": "<=",
"value": 5,
"unit": "x UNL"
}
]
}
}
},
"else_criteria": null
}
]
}
},
{
"identified_line": {
"line": "* Serum creatinine ≤ 1.5 x UNL",
"criterions": [
{
"exact_snippets": "Serum creatinine ≤ 1.5 x UNL",
"criterion": "serum creatinine",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "x UNL"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Serum creatinine ≤ 1.5 x UNL",
"criterion": "serum creatinine",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "x UNL"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Magnesium ≥ lower limit of normal",
"criterions": [
{
"exact_snippets": "Magnesium ≥ lower limit of normal",
"criterion": "magnesium level",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": ">=",
"value": 0,
"unit": "lower limit of normal"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Magnesium ≥ lower limit of normal",
"criterion": "magnesium level",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": ">=",
"value": 0,
"unit": "lower limit of normal"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Calcium ≥ lower limit of normal",
"criterions": [
{
"exact_snippets": "Calcium ≥ lower limit of normal",
"criterion": "calcium level",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": ">=",
"value": 0,
"unit": "lower limit of normal"
}
}
}
]
},
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{
"exact_snippets": "Calcium ≥ lower limit of normal",
"criterion": "calcium level",
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"expected_value": {
"operator": ">=",
"value": 0,
"unit": "lower limit of normal"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Written informed consent",
"criterions": [
{
"exact_snippets": "Written informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "form",
"expected_value": "written"
}
}
]
},
"logical_structure": {
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"exact_snippets": "Written informed consent",
"criterion": "informed consent",
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}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
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"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
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"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
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"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
}
},
{
"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": {
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Adequate bone marrow function, liver function, renal function and coagulation parameters (within 7 days prior to randomization):",
"criterions": [
{
"exact_snippets": "Adequate bone marrow function",
"criterion": "bone marrow function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": "adequate"
}
},
{
"exact_snippets": "adequate ... liver function",
"criterion": "liver function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": "adequate"
}
},
{
"exact_snippets": "adequate ... renal function",
"criterion": "renal function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": "adequate"
}
},
{
"exact_snippets": "adequate ... coagulation parameters",
"criterion": "coagulation parameters",
"requirement": {
"requirement_type": "adequacy",
"expected_value": "adequate"
}
}
]
},
"logical_structure": {
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"exact_snippets": "Adequate bone marrow function",
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"requirement_type": "adequacy",
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{
"exact_snippets": "adequate ... liver function",
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"requirement_type": "adequacy",
"expected_value": "adequate"
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},
{
"exact_snippets": "adequate ... renal function",
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"requirement_type": "adequacy",
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},
{
"exact_snippets": "adequate ... coagulation parameters",
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"requirement_type": "adequacy",
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]
}
}
],
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"identified_line": {
"line": "* Pregnant or breast-feeding or planning to become pregnant within 6 months after end of treatment. For fertile women a negative pregnancy test at screening is mandatory.",
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},
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"exact_snippets": "CNS metastasis",
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]
}
},
{
"identified_line": {
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"exact_snippets": "laboratory abnormality",
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{
"exact_snippets": "in the opinion of the Investigator may increase the risks associated with study drug administration",
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{
"and_criteria": [
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"exact_snippets": "in the opinion of the Investigator may increase the risks associated with study drug administration",
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"exact_snippets": "in the opinion of the Investigator may increase the risks associated with study drug administration",
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"exact_snippets": "unstable angina within 6 months of randomization.",
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}
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"exact_snippets": "New York Heart Association (NYHA) ≥ Grade 2 congestive heart failure",
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}
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}
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"exact_snippets": "rate-controlled atrial fibrillation",
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]
},
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},
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"requirement_type": "range",
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"exact_snippets": "Uncontrolled hypercalcemia (calcium level outside the upper limit of normal",
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"exact_snippets": "Allergy ... to Staphylococcus Protein A",
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{
"exact_snippets": "History of ... pulmonary fibrosis",
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"exact_snippets": "evidence of interstitial lung disease on baseline chest CT scan",
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{
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],
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"identified_line": {
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"exact_snippets": "1. line chemotherapy with platinum",
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}
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}
]
}
},
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}
},
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"or_criteria": [
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"exact_snippets": "Patients who have received (or are planning to receive) treatment with any other investigational agent",
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}
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}
},
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"identified_line": {
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},
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"exact_snippets": "except curatively treated cervical cancer",
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},
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"exact_snippets": "except ... non-melanotic skin cancer",
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}
},
{
"exact_snippets": "except ... other cancer with minimal risk of relapse",
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"and_criteria": [
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"not_criteria": {
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}
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]
},
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"unit": "year"
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],
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}