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(5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":49}],"term":"Renal Calculi"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":49}],"term":"Pleural Effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":49}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":49}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":49}],"term":"Hypertension"}],"timeFrame":"The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months."}