{"description":"All 35 patients enrolled in the trial were monitored for mortality, 30 of them started protocol therapy after registration and reported adverse events data. Serious adverse events are defined as grade 3 or higher adverse events.","eventGroups":[{"deathsNumAffected":30,"deathsNumAtRisk":35,"description":"Patients receive copanlisib IV over 1 hour on days 1, 8, and 15 of each cycle. 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4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30}],"term":"General disorders and administration site conditions - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":30}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":30}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":30}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30}],"term":"Gastroesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":30}],"term":"Mucositis oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":30}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":30}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":30}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":30}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":30}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30}],"term":"Hypomagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30}],"term":"Generalized muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30}],"term":"Musculoskeletal and connective tissue disorder - Other, spe"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":30}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":30}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30}],"term":"Blurred vision"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":30}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30}],"term":"Mucositis oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30}],"term":"Oral pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30}],"term":"Meningitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":30}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30}],"term":"Hypoglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30}],"term":"Hypophosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30}],"term":"Generalized muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":30}],"term":"Hypertension"}],"timeFrame":"Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration."}