{"eventGroups":[{"description":"Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m\\^2 of gemcitabine IV and 80 mg/m\\^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.","id":"EG000","otherNumAffected":73,"otherNumAtRisk":74,"seriousNumAffected":2,"seriousNumAtRisk":74,"title":"Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":49,"numAtRisk":74}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":74}],"term":"Blurred vision"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":74}],"term":"Abdominal pain/cramping"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":74}],"term":"Constipation/bowel obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":74}],"term":"Diarrhea without colostomy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":74}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":74}],"term":"Stomatitis/pharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":74}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":74}],"term":"Edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":61,"numAtRisk":74}],"term":"Fatigue/malaise/lethargy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":74}],"term":"Fever without neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":74}],"term":"Pain-other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":74}],"term":"Rigors/chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":74}],"term":"Allergic reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":74}],"term":"Infection w/o 3-4 neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":74}],"term":"Infection, unk ANC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":74}],"term":"Urinary tr infect w/o neutrop"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":74}],"term":"Creatinine increase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":48,"numAtRisk":74}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":74}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":54,"numAtRisk":74}],"term":"Neutropenia/granulocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":74}],"term":"SGOT (AST) increase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":74}],"term":"SGPT (ALT) increase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":41,"numAtRisk":74}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":74}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":74}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":74}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":74}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":74}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":74}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":74}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":74}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":74}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":74}],"term":"Dizziness/light headedness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":74}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":74}],"term":"Sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":74}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":74}],"term":"Dysuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":74}],"term":"Hematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":74}],"term":"Urinary frequency/urgency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":74}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":74}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":74}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":74}],"term":"Rash/desquamation"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74}],"term":"GI-other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74}],"term":"Infection with 3-4 neutropenia"}],"timeFrame":"Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery"}