{
"info": {
"nct_id": "NCT00091273",
"official_title": "Evaluation of Safety and Immunogenicity of a Peptide Vaccine in Patients With Epithelial Ovarian or Primary Peritoneal Cancer",
"inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed ovarian epithelial or primary peritoneal cancer\n* Completed primary therapy (surgery and chemotherapy for newly diagnosed disease) within the past 12 months and meets 1 of the following criteria:\n\n * Clinical or radiographic evidence of disease\n * Serologic evidence of disease\n * Initial diagnosis of stage III or IV disease AND completed anticancer therapy within the past 12 months\n* At least 2 intact axillary and/or inguinal lymph node basins\n\n * Prior lymph node biopsy allowed provided lymphoscintigraphy demonstrates intact drainage to a node in that basin\n* HLA-A1-, -A2-, or -A3-positive\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* GOG 0-2\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Absolute neutrophil count > 1,500/mm^3\n* Hemoglobin > 8.0 g/dL OR\n* Hematocrit > 25%\n* Platelet count ≥ 80,000/mm^3\n\nHepatic\n\n* AST and ALT ≤ 2.5 times upper limit of normal\n* Hepatitis C negative\n\nRenal\n\n* Not specified\n\nCardiovascular\n\n* No New York Heart Association class III or IV heart disease\n\nImmunologic\n\n* HIV negative\n* No active infection requiring antibiotics\n* No prior or active autoimmune disorder requiring cytotoxic or immunosuppressive therapy\n* No prior autoimmune disorder with visceral involvement\n* No known or suspected allergy to any component of the study vaccine\n* The following immunologic conditions are allowed:\n\n * Laboratory evidence of autoimmune disease (e.g., positive antinuclear antibody titer) that is asymptomatic\n * Clinical evidence of vitiligo or other forms of depigmenting illness\n * Mild arthritis requiring non-steroidal anti-inflammatory drugs\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Weight ≥ 110 lbs\n* No uncontrolled diabetes, defined as hemoglobin A1C ≥ 7%\n* No active hyperthyroidism\n* No current or recent (within the past year) addiction to alcohol or drugs\n* No medical contraindication or other potential medical problem that would preclude study compliance\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* More than 2 weeks since prior and no concurrent allergy desensitization injections\n* More than 2 weeks since prior and no concurrent growth factors (e.g., epoetin alfa or pegfilgrastim)\n* More than 1 month since prior and no other concurrent immunotherapy\n* More than 2 weeks since prior and no other concurrent potential immunomodulating agents, including any of the following:\n\n * Interferon\n * Tumor necrosis factor\n * Interleukins or other cytokines\n * Biologic response modifiers\n * Monoclonal antibodies\n* No prior vaccination with all of the study peptides relevant to the patient's HLA-type\n\nChemotherapy\n\n* See Disease Characteristics\n* More than 1 month since prior chemotherapy and recovered\n* No concurrent cytotoxic chemotherapy\n\nEndocrine therapy\n\n* More than 2 weeks since prior and no concurrent parenteral or oral corticosteroids (e.g., prednisone or albuterol)\n\n * Topical corticosteroids allowed\n\nRadiotherapy\n\n* More than 1 month since prior radiotherapy and recovered\n\nSurgery\n\n* See Disease Characteristics\n* More than 1 month since prior surgery and recovered\n\nOther\n\n* More than 1 month since other prior treatment and recovered\n* More than 1 month since prior and no other concurrent investigational agents"
},
"inclusion_lines": [
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirements": [
{
"requirement_type": "expected_value",
"expected_value": "female"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [],
"miscellaneous_lines": [
{
"line": "DISEASE CHARACTERISTICS:",
"criterions": [
{
"exact_snippets": "DISEASE CHARACTERISTICS",
"criterion": "disease characteristics",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "N/A"
}
]
}
]
},
{
"line": "* Histologically confirmed ovarian epithelial or primary peritoneal cancer",
"criterions": [
{
"exact_snippets": "Histologically confirmed ovarian epithelial",
"criterion": "ovarian epithelial cancer",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": "histologically confirmed"
}
]
},
{
"exact_snippets": "Histologically confirmed ... primary peritoneal cancer",
"criterion": "primary peritoneal cancer",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": "histologically confirmed"
}
]
}
]
},
{
"line": "* Completed primary therapy (surgery and chemotherapy for newly diagnosed disease) within the past 12 months and meets 1 of the following criteria:",
"criterions": [
{
"exact_snippets": "Completed primary therapy (surgery and chemotherapy for newly diagnosed disease)",
"criterion": "primary therapy completion",
"requirements": [
{
"requirement_type": "completion",
"expected_value": true
}
]
},
{
"exact_snippets": "within the past 12 months",
"criterion": "time since primary therapy completion",
"requirements": [
{
"requirement_type": "time since completion",
"expected_value": {
"operator": "<=",
"value": 12,
"unit": "months"
}
}
]
}
]
},
{
"line": "* Clinical or radiographic evidence of disease",
"criterions": [
{
"exact_snippets": "Clinical or radiographic evidence of disease",
"criterion": "disease evidence",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Serologic evidence of disease",
"criterions": [
{
"exact_snippets": "Serologic evidence of disease",
"criterion": "serologic evidence of disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Initial diagnosis of stage III or IV disease AND completed anticancer therapy within the past 12 months",
"criterions": [
{
"exact_snippets": "Initial diagnosis of stage III or IV disease",
"criterion": "disease stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": [
"III",
"IV"
]
}
]
},
{
"exact_snippets": "completed anticancer therapy within the past 12 months",
"criterion": "anticancer therapy completion",
"requirements": [
{
"requirement_type": "completion time",
"expected_value": {
"operator": "<=",
"value": 12,
"unit": "months"
}
}
]
}
]
},
{
"line": "* At least 2 intact axillary and/or inguinal lymph node basins",
"criterions": [
{
"exact_snippets": "At least 2 intact axillary and/or inguinal lymph node basins",
"criterion": "intact axillary and/or inguinal lymph node basins",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* Prior lymph node biopsy allowed provided lymphoscintigraphy demonstrates intact drainage to a node in that basin",
"criterions": [
{
"exact_snippets": "Prior lymph node biopsy allowed",
"criterion": "prior lymph node biopsy",
"requirements": [
{
"requirement_type": "allowance",
"expected_value": true
}
]
},
{
"exact_snippets": "lymphoscintigraphy demonstrates intact drainage to a node in that basin",
"criterion": "lymphoscintigraphy",
"requirements": [
{
"requirement_type": "drainage",
"expected_value": "intact"
}
]
}
]
},
{
"line": "* HLA-A1-, -A2-, or -A3-positive",
"criterions": [
{
"exact_snippets": "HLA-A1-, -A2-, or -A3-positive",
"criterion": "HLA type",
"requirements": [
{
"requirement_type": "presence",
"expected_value": [
"HLA-A1",
"HLA-A2",
"HLA-A3"
]
}
]
}
]
},
{
"line": "Age",
"criterions": [
{
"exact_snippets": "Age",
"criterion": "age",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "N/A"
}
]
}
]
},
{
"line": "* 18 and over",
"criterions": [
{
"exact_snippets": "18 and over",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "Performance status",
"criterions": [
{
"exact_snippets": "Performance status",
"criterion": "performance status",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "N/A"
}
]
}
]
},
{
"line": "* GOG 0-2",
"criterions": [
{
"exact_snippets": "GOG 0-2",
"criterion": "GOG performance status",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
]
}
]
},
{
"line": "Life expectancy",
"criterions": [
{
"exact_snippets": "Life expectancy",
"criterion": "life expectancy",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "N/A"
}
]
}
]
},
{
"line": "Hematopoietic",
"criterions": [
{
"exact_snippets": "Hematopoietic",
"criterion": "hematopoietic system",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Absolute neutrophil count > 1,500/mm^3",
"criterions": [
{
"exact_snippets": "Absolute neutrophil count > 1,500/mm^3",
"criterion": "absolute neutrophil count",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 1500,
"unit": "mm^3"
}
}
]
}
]
},
{
"line": "* Hemoglobin > 8.0 g/dL OR",
"criterions": [
{
"exact_snippets": "Hemoglobin > 8.0 g/dL",
"criterion": "hemoglobin level",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 8.0,
"unit": "g/dL"
}
}
]
}
]
},
{
"line": "* Hematocrit > 25%",
"criterions": [
{
"exact_snippets": "Hematocrit > 25%",
"criterion": "hematocrit",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 25,
"unit": "%"
}
}
]
}
]
},
{
"line": "* Platelet count ≥ 80,000/mm^3",
"criterions": [
{
"exact_snippets": "Platelet count ≥ 80,000/mm^3",
"criterion": "platelet count",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 80000,
"unit": "mm^3"
}
}
]
}
]
},
{
"line": "Hepatic",
"criterions": [
{
"exact_snippets": "Hepatic",
"criterion": "hepatic function",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* AST and ALT ≤ 2.5 times upper limit of normal",
"criterions": [
{
"exact_snippets": "AST and ALT ≤ 2.5 times upper limit of normal",
"criterion": "AST",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 2.5,
"unit": "times upper limit of normal"
}
}
]
},
{
"exact_snippets": "AST and ALT ≤ 2.5 times upper limit of normal",
"criterion": "ALT",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 2.5,
"unit": "times upper limit of normal"
}
}
]
}
]
},
{
"line": "* Hepatitis C negative",
"criterions": [
{
"exact_snippets": "Hepatitis C negative",
"criterion": "Hepatitis C",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "Renal",
"criterions": [
{
"exact_snippets": "Renal",
"criterion": "renal function",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "Cardiovascular",
"criterions": [
{
"exact_snippets": "Cardiovascular",
"criterion": "cardiovascular condition",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* No New York Heart Association class III or IV heart disease",
"criterions": [
{
"exact_snippets": "No New York Heart Association class III or IV heart disease",
"criterion": "New York Heart Association heart disease class",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": "!=",
"value": 3,
"unit": "class"
}
},
{
"requirement_type": "severity",
"expected_value": {
"operator": "!=",
"value": 4,
"unit": "class"
}
}
]
}
]
},
{
"line": "Immunologic",
"criterions": [
{
"exact_snippets": "Immunologic",
"criterion": "immunologic status",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "immunologic"
}
]
}
]
},
{
"line": "* HIV negative",
"criterions": [
{
"exact_snippets": "HIV negative",
"criterion": "HIV status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "negative"
}
]
}
]
},
{
"line": "* No active infection requiring antibiotics",
"criterions": [
{
"exact_snippets": "No active infection requiring antibiotics",
"criterion": "active infection",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "No active infection requiring antibiotics",
"criterion": "antibiotics requirement",
"requirements": [
{
"requirement_type": "necessity",
"expected_value": false
}
]
}
]
},
{
"line": "* No prior or active autoimmune disorder requiring cytotoxic or immunosuppressive therapy",
"criterions": [
{
"exact_snippets": "No prior or active autoimmune disorder",
"criterion": "autoimmune disorder",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "requiring cytotoxic or immunosuppressive therapy",
"criterion": "autoimmune disorder treatment",
"requirements": [
{
"requirement_type": "treatment type",
"expected_value": [
"cytotoxic",
"immunosuppressive"
]
}
]
}
]
},
{
"line": "* No prior autoimmune disorder with visceral involvement",
"criterions": [
{
"exact_snippets": "No prior autoimmune disorder with visceral involvement",
"criterion": "autoimmune disorder with visceral involvement",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* No known or suspected allergy to any component of the study vaccine",
"criterions": [
{
"exact_snippets": "No known or suspected allergy to any component of the study vaccine",
"criterion": "allergy to study vaccine components",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* The following immunologic conditions are allowed:",
"criterions": [
{
"exact_snippets": "immunologic conditions",
"criterion": "immunologic conditions",
"requirements": [
{
"requirement_type": "allowance",
"expected_value": true
}
]
}
]
},
{
"line": "* Laboratory evidence of autoimmune disease (e.g., positive antinuclear antibody titer) that is asymptomatic",
"criterions": [
{
"exact_snippets": "Laboratory evidence of autoimmune disease",
"criterion": "autoimmune disease",
"requirements": [
{
"requirement_type": "evidence",
"expected_value": "laboratory"
}
]
},
{
"exact_snippets": "positive antinuclear antibody titer",
"criterion": "antinuclear antibody titer",
"requirements": [
{
"requirement_type": "result",
"expected_value": "positive"
}
]
},
{
"exact_snippets": "asymptomatic",
"criterion": "autoimmune disease",
"requirements": [
{
"requirement_type": "symptoms",
"expected_value": false
}
]
}
]
},
{
"line": "* Clinical evidence of vitiligo or other forms of depigmenting illness",
"criterions": [
{
"exact_snippets": "Clinical evidence of vitiligo",
"criterion": "vitiligo",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "other forms of depigmenting illness",
"criterion": "depigmenting illness",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Mild arthritis requiring non-steroidal anti-inflammatory drugs",
"criterions": [
{
"exact_snippets": "Mild arthritis",
"criterion": "arthritis",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "mild"
}
]
},
{
"exact_snippets": "requiring non-steroidal anti-inflammatory drugs",
"criterion": "non-steroidal anti-inflammatory drugs",
"requirements": [
{
"requirement_type": "necessity",
"expected_value": true
}
]
}
]
},
{
"line": "* Negative pregnancy test",
"criterions": [
{
"exact_snippets": "Negative pregnancy test",
"criterion": "pregnancy test",
"requirements": [
{
"requirement_type": "result",
"expected_value": "negative"
}
]
}
]
},
{
"line": "* Fertile patients must use effective contraception",
"criterions": [
{
"exact_snippets": "Fertile patients",
"criterion": "fertility",
"requirements": [
{
"requirement_type": "status",
"expected_value": "fertile"
}
]
},
{
"exact_snippets": "must use effective contraception",
"criterion": "contraception use",
"requirements": [
{
"requirement_type": "necessity",
"expected_value": true
}
]
}
]
},
{
"line": "* Weight ≥ 110 lbs",
"criterions": [
{
"exact_snippets": "Weight ≥ 110 lbs",
"criterion": "weight",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 110,
"unit": "lbs"
}
}
]
}
]
},
{
"line": "* No uncontrolled diabetes, defined as hemoglobin A1C ≥ 7%",
"criterions": [
{
"exact_snippets": "uncontrolled diabetes, defined as hemoglobin A1C ≥ 7%",
"criterion": "diabetes",
"requirements": [
{
"requirement_type": "control",
"expected_value": false
},
{
"requirement_type": "hemoglobin A1C",
"expected_value": {
"operator": ">=",
"value": 7,
"unit": "%"
}
}
]
}
]
},
{
"line": "* No active hyperthyroidism",
"criterions": [
{
"exact_snippets": "No active hyperthyroidism",
"criterion": "hyperthyroidism",
"requirements": [
{
"requirement_type": "activity",
"expected_value": false
}
]
}
]
},
{
"line": "* No current or recent (within the past year) addiction to alcohol or drugs",
"criterions": [
{
"exact_snippets": "No current or recent (within the past year) addiction to alcohol",
"criterion": "addiction to alcohol",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "No current or recent (within the past year) addiction to ... drugs",
"criterion": "addiction to drugs",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* No medical contraindication or other potential medical problem that would preclude study compliance",
"criterions": [
{
"exact_snippets": "No medical contraindication",
"criterion": "medical contraindication",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "other potential medical problem that would preclude study compliance",
"criterion": "potential medical problem",
"requirements": [
{
"requirement_type": "impact on study compliance",
"expected_value": false
}
]
}
]
},
{
"line": "PRIOR CONCURRENT THERAPY:",
"criterions": [
{
"exact_snippets": "PRIOR CONCURRENT THERAPY",
"criterion": "prior concurrent therapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "Biologic therapy",
"criterions": [
{
"exact_snippets": "Biologic therapy",
"criterion": "biologic therapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* More than 2 weeks since prior and no concurrent allergy desensitization injections",
"criterions": [
{
"exact_snippets": "More than 2 weeks since prior ... allergy desensitization injections",
"criterion": "allergy desensitization injections",
"requirements": [
{
"requirement_type": "time since prior",
"expected_value": {
"operator": ">",
"value": 2,
"unit": "weeks"
}
},
{
"requirement_type": "concurrent administration",
"expected_value": false
}
]
}
]
},
{
"line": "* More than 2 weeks since prior and no concurrent growth factors (e.g., epoetin alfa or pegfilgrastim)",
"criterions": [
{
"exact_snippets": "More than 2 weeks since prior ... growth factors",
"criterion": "growth factors",
"requirements": [
{
"requirement_type": "time since prior",
"expected_value": {
"operator": ">",
"value": 2,
"unit": "weeks"
}
},
{
"requirement_type": "concurrent use",
"expected_value": false
}
]
}
]
},
{
"line": "* More than 1 month since prior and no other concurrent immunotherapy",
"criterions": [
{
"exact_snippets": "More than 1 month since prior ... immunotherapy",
"criterion": "immunotherapy",
"requirements": [
{
"requirement_type": "time since prior treatment",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "month"
}
},
{
"requirement_type": "concurrent treatment",
"expected_value": false
}
]
}
]
},
{
"line": "* More than 2 weeks since prior and no other concurrent potential immunomodulating agents, including any of the following:",
"criterions": [
{
"exact_snippets": "More than 2 weeks since prior ... concurrent potential immunomodulating agents",
"criterion": "immunomodulating agents",
"requirements": [
{
"requirement_type": "time since prior use",
"expected_value": {
"operator": ">",
"value": 2,
"unit": "weeks"
}
},
{
"requirement_type": "concurrent use",
"expected_value": false
}
]
}
]
},
{
"line": "* Interferon",
"criterions": [
{
"exact_snippets": "Interferon",
"criterion": "interferon",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Tumor necrosis factor",
"criterions": [
{
"exact_snippets": "Tumor necrosis factor",
"criterion": "tumor necrosis factor",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Interleukins or other cytokines",
"criterions": [
{
"exact_snippets": "Interleukins",
"criterion": "interleukins",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "other cytokines",
"criterion": "cytokines",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Biologic response modifiers",
"criterions": [
{
"exact_snippets": "Biologic response modifiers",
"criterion": "biologic response modifiers",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Monoclonal antibodies",
"criterions": [
{
"exact_snippets": "Monoclonal antibodies",
"criterion": "monoclonal antibodies",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* No prior vaccination with all of the study peptides relevant to the patient's HLA-type",
"criterions": [
{
"exact_snippets": "No prior vaccination with all of the study peptides relevant to the patient's HLA-type",
"criterion": "prior vaccination with study peptides",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "Chemotherapy",
"criterions": [
{
"exact_snippets": "Chemotherapy",
"criterion": "chemotherapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* See Disease Characteristics",
"criterions": [
{
"exact_snippets": "Disease Characteristics",
"criterion": "disease characteristics",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "see details"
}
]
}
]
},
{
"line": "* More than 1 month since prior chemotherapy and recovered",
"criterions": [
{
"exact_snippets": "More than 1 month since prior chemotherapy",
"criterion": "time since prior chemotherapy",
"requirements": [
{
"requirement_type": "time elapsed",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "month"
}
}
]
},
{
"exact_snippets": "recovered",
"criterion": "recovery from prior chemotherapy",
"requirements": [
{
"requirement_type": "recovery status",
"expected_value": true
}
]
}
]
},
{
"line": "* No concurrent cytotoxic chemotherapy",
"criterions": [
{
"exact_snippets": "No concurrent cytotoxic chemotherapy",
"criterion": "cytotoxic chemotherapy",
"requirements": [
{
"requirement_type": "concurrency",
"expected_value": false
}
]
}
]
},
{
"line": "Endocrine therapy",
"criterions": [
{
"exact_snippets": "Endocrine therapy",
"criterion": "endocrine therapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* More than 2 weeks since prior and no concurrent parenteral or oral corticosteroids (e.g., prednisone or albuterol)",
"criterions": [
{
"exact_snippets": "More than 2 weeks since prior ... parenteral or oral corticosteroids",
"criterion": "time since prior corticosteroids",
"requirements": [
{
"requirement_type": "time since",
"expected_value": {
"operator": ">",
"value": 2,
"unit": "weeks"
}
}
]
},
{
"exact_snippets": "no concurrent parenteral or oral corticosteroids",
"criterion": "concurrent corticosteroids",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Topical corticosteroids allowed",
"criterions": [
{
"exact_snippets": "Topical corticosteroids allowed",
"criterion": "topical corticosteroids",
"requirements": [
{
"requirement_type": "allowance",
"expected_value": true
}
]
}
]
},
{
"line": "Radiotherapy",
"criterions": [
{
"exact_snippets": "Radiotherapy",
"criterion": "radiotherapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* More than 1 month since prior radiotherapy and recovered",
"criterions": [
{
"exact_snippets": "More than 1 month since prior radiotherapy",
"criterion": "time since prior radiotherapy",
"requirements": [
{
"requirement_type": "time elapsed",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "month"
}
}
]
},
{
"exact_snippets": "recovered",
"criterion": "recovery from prior radiotherapy",
"requirements": [
{
"requirement_type": "recovery status",
"expected_value": true
}
]
}
]
},
{
"line": "Surgery",
"criterions": [
{
"exact_snippets": "Surgery",
"criterion": "surgery",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* See Disease Characteristics",
"criterions": [
{
"exact_snippets": "Disease Characteristics",
"criterion": "disease characteristics",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": "see disease characteristics"
}
]
}
]
},
{
"line": "* More than 1 month since prior surgery and recovered",
"criterions": [
{
"exact_snippets": "More than 1 month since prior surgery",
"criterion": "time since prior surgery",
"requirements": [
{
"requirement_type": "time elapsed",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "month"
}
}
]
},
{
"exact_snippets": "recovered",
"criterion": "recovery from prior surgery",
"requirements": [
{
"requirement_type": "recovery status",
"expected_value": true
}
]
}
]
},
{
"line": "* More than 1 month since other prior treatment and recovered",
"criterions": [
{
"exact_snippets": "More than 1 month since other prior treatment",
"criterion": "time since prior treatment",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "month"
}
}
]
},
{
"exact_snippets": "recovered",
"criterion": "recovery from prior treatment",
"requirements": [
{
"requirement_type": "status",
"expected_value": "recovered"
}
]
}
]
},
{
"line": "* More than 1 month since prior and no other concurrent investigational agents",
"criterions": [
{
"exact_snippets": "More than 1 month since prior ... investigational agents",
"criterion": "time since prior investigational agents",
"requirements": [
{
"requirement_type": "time since",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "month"
}
}
]
},
{
"exact_snippets": "no other concurrent investigational agents",
"criterion": "concurrent investigational agents",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": [
{
"line": "PATIENT CHARACTERISTICS:",
"criterions": []
},
{
"line": "* Not specified",
"criterions": []
},
{
"line": "* Not specified",
"criterions": []
},
{
"line": "Other",
"criterions": []
},
{
"line": "* Not pregnant or nursing",
"criterions": [
{
"exact_snippets": "Not pregnant",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "status",
"expected_value": false
}
]
},
{
"exact_snippets": "not ... nursing",
"criterion": "nursing",
"requirements": [
{
"requirement_type": "status",
"expected_value": false
}
]
}
]
},
{
"line": "Other",
"criterions": []
}
]
}