{"description":"CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).","eventGroups":[{"deathsNumAffected":1,"deathsNumAtRisk":13,"description":"Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV","id":"EG000","otherNumAffected":13,"otherNumAtRisk":13,"seriousNumAffected":11,"seriousNumAtRisk":13,"title":"Treatment (Chemotherapy)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":13,"numEvents":9}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":13,"numEvents":14}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":13,"numEvents":10}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":3}],"term":"Edema limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":13,"numEvents":28}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":13,"numEvents":7}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":2}],"term":"Bronchial infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13,"numEvents":2}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":13,"numEvents":4}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13,"numEvents":2}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":13,"numEvents":6}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":13,"numEvents":18}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":13,"numEvents":11}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":13,"numEvents":23}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":13,"numEvents":6}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13,"numEvents":3}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Hyperuricemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":2}],"term":"Peripheral motor neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":13,"numEvents":26}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":13,"numEvents":16}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":2}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13,"numEvents":5}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":13,"numEvents":11}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":13,"numEvents":4}],"term":"Hypotension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13,"numEvents":3}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Cardiac disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Duodenal ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Esophageal necrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Gastric ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Gastrointestinal disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":2}],"term":"Edema limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Enterocolitis infectious"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13,"numEvents":2}],"term":"Infections and infestations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":13,"numEvents":3}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":2}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":13,"numEvents":6}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":13,"numEvents":3}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":13,"numEvents":5}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":13,"numEvents":3}],"term":"Hypercalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Hyperuricemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13,"numEvents":2}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Hypophosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":2}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Generalized muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":2}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":13,"numEvents":3}],"term":"Chronic kidney disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13,"numEvents":2}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":2}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Skin ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Thromboembolic event"}],"timeFrame":"Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years."}