{"description":"All Serious Adverse Events (SAEs) are reported, irrespective of grade or attribution. For other Adverse Events (AEs), only those grade 3 or higher are collected with a threshold set at 3.5% within any arm. AEs and SAEs are assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Assessments are made by laboratory tests, physical exam, and other clinical measurements (e.g. ECGs, radiological scans, vital signs, etc.)","eventGroups":[{"deathsNumAffected":23,"deathsNumAtRisk":29,"description":"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and pazopanib hydrochloride PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n\nGemcitabine: Given IV\n\nGemcitabine Hydrochloride: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPazopanib: Given PO\n\nPazopanib Hydrochloride: Given PO","id":"EG000","otherNumAffected":25,"otherNumAtRisk":29,"seriousNumAffected":8,"seriousNumAtRisk":29,"title":"Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride"},{"deathsNumAffected":10,"deathsNumAtRisk":11,"description":"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and placebo PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression, are unblinded and found randomized to placebo arm may crossover to receive open-label pazopanib hydrochloride PO daily.\n\nAEs and deaths reported only while participant is in placebo arm/group.\n\nGemcitabine: Given IV\n\nGemcitabine Hydrochloride: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPazopanib: Given PO\n\nPazopanib Hydrochloride: Given PO\n\nPlacebo Administration: Given PO","id":"EG001","otherNumAffected":14,"otherNumAtRisk":25,"seriousNumAffected":6,"seriousNumAtRisk":25,"title":"Gemcitabine Hydrochloride Plus Placebo"},{"deathsNumAffected":11,"deathsNumAtRisk":14,"description":"Patients who progress and found randomized to the placebo arm after unblinding are eligible for receipt of open-label gemcitabine plus pazopanib. Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and pazopanib hydrochloride PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. AEs and deaths collected during this treatment period","id":"EG002","otherNumAffected":9,"otherNumAtRisk":14,"seriousNumAffected":5,"seriousNumAtRisk":14,"title":"Crossover From Gemcitabine Plus Placebo to Gemcitabine Plus Open-label Pazopanib"}],"frequencyThreshold":"4","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29},{"groupId":"EG001","numAffected":1,"numAtRisk":25},{"groupId":"EG002","numAffected":2,"numAtRisk":14}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":29},{"groupId":"EG001","numAffected":1,"numAtRisk":25},{"groupId":"EG002","numAffected":0,"numAtRisk":14}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":29},{"groupId":"EG001","numAffected":3,"numAtRisk":25},{"groupId":"EG002","numAffected":0,"numAtRisk":14}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":29},{"groupId":"EG001","numAffected":1,"numAtRisk":25},{"groupId":"EG002","numAffected":0,"numAtRisk":14}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":0,"numAtRisk":14}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":2,"numAtRisk":14}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":29},{"groupId":"EG001","numAffected":2,"numAtRisk":25},{"groupId":"EG002","numAffected":0,"numAtRisk":14}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":29},{"groupId":"EG001","numAffected":1,"numAtRisk":25},{"groupId":"EG002","numAffected":1,"numAtRisk":14}],"term":"Heart failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":0,"numAtRisk":14}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":1,"numAtRisk":14}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29},{"groupId":"EG001","numAffected":1,"numAtRisk":25},{"groupId":"EG002","numAffected":2,"numAtRisk":14}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":0,"numAtRisk":14}],"term":"Hypophosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":0,"numAtRisk":14}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":29},{"groupId":"EG001","numAffected":9,"numAtRisk":25},{"groupId":"EG002","numAffected":1,"numAtRisk":14}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":0,"numAtRisk":14}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":0,"numAtRisk":14}],"term":"Thromboembolic event"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":29},{"groupId":"EG001","numAffected":1,"numAtRisk":25},{"groupId":"EG002","numAffected":0,"numAtRisk":14}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":1,"numAtRisk":14}],"term":"Ejection fraction decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":1,"numAtRisk":14}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":1,"numAtRisk":14}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":1,"numAtRisk":14}],"term":"Gastric perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":1,"numAtRisk":14}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":1,"numAtRisk":14}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":1,"numAtRisk":14}],"term":"Pulmonary edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":1,"numAtRisk":14}],"term":"Tumor pain"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29},{"groupId":"EG001","numAffected":1,"numAtRisk":25},{"groupId":"EG002","numAffected":1,"numAtRisk":14}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":29},{"groupId":"EG001","numAffected":1,"numAtRisk":25},{"groupId":"EG002","numAffected":0,"numAtRisk":14}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":29},{"groupId":"EG001","numAffected":1,"numAtRisk":25},{"groupId":"EG002","numAffected":0,"numAtRisk":14}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":1,"numAtRisk":14}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":1,"numAtRisk":14}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":0,"numAtRisk":14}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":1,"numAtRisk":14}],"term":"Gastric perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":29},{"groupId":"EG001","numAffected":1,"numAtRisk":25},{"groupId":"EG002","numAffected":1,"numAtRisk":14}],"term":"Heart failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":0,"numAtRisk":14}],"term":"Hepatic failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":0,"numAtRisk":14}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":1,"numAtRisk":14}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29},{"groupId":"EG001","numAffected":1,"numAtRisk":25},{"groupId":"EG002","numAffected":0,"numAtRisk":14}],"term":"Proteinuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29},{"groupId":"EG001","numAffected":1,"numAtRisk":25},{"groupId":"EG002","numAffected":0,"numAtRisk":14}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29},{"groupId":"EG001","numAffected":1,"numAtRisk":25},{"groupId":"EG002","numAffected":0,"numAtRisk":14}],"term":"Supraventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":0,"numAtRisk":14}],"term":"Thromboembolic event"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":1,"numAtRisk":14}],"term":"Tumor pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":1,"numAtRisk":14}],"term":"Ejection fraction decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29},{"groupId":"EG001","numAffected":1,"numAtRisk":25},{"groupId":"EG002","numAffected":0,"numAtRisk":14}],"term":"Acute coronary syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29},{"groupId":"EG001","numAffected":1,"numAtRisk":25},{"groupId":"EG002","numAffected":0,"numAtRisk":14}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":0,"numAtRisk":14}],"term":"Cardiac troponin I increase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":0,"numAtRisk":14}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":1,"numAtRisk":14}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29},{"groupId":"EG001","numAffected":1,"numAtRisk":25},{"groupId":"EG002","numAffected":0,"numAtRisk":14}],"term":"Hypoglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":0,"numAtRisk":14}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":0,"numAtRisk":14}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":1,"numAtRisk":14}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":0,"numAtRisk":14}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":0,"numAtRisk":14}],"term":"Pulmonary edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":0,"numAtRisk":14}],"term":"Edema limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":0,"numAtRisk":14}],"term":"Edema trunk"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":29},{"groupId":"EG001","numAffected":0,"numAtRisk":25},{"groupId":"EG002","numAffected":0,"numAtRisk":14}],"term":"Atrial fibrillation"}],"timeFrame":"Adverse events were collected up 30 days after the last dose of study drugs while participant was in that Arm/Group. All-Cause Mortality was assessed up to 3 years. For SAEs and OAEs, the Gem+Pazo group was assessed up to 32.1 months; Gem+Placebo participants were assessed up to 36.0 months (30 days after progression). If Gem+Placebo participants crossed over to open-label Pazo after progression, any additional AEs were collected under the crossover arm (up to 16.6 months)."}