{"description":"Adverse Events were graded in accordance with CTCAE v4.03","eventGroups":[{"deathsNumAffected":2,"deathsNumAtRisk":19,"description":"ASP7487 administered orally 75, 100 and 150 mg) BID continuously for each cycle. Bortezomib administered at 1.3 mg/m2 twice weekly for the first 8 21 day cycles and once weekly beyond cycle 9 for 35 day cycles. Dexamethasone is administered on bortezomib administration days at 20 mg\n\nASP7487, Velcade, Dexamethasone: ASP7487- Oral (75, 100, 150 mg)BID Bortezomib- 1.3 mg/m2 IV on days 1, 4, 8, 15 of each 21 day cycle up to cycle 8 and days 1, 5, 15, 22 of each 35 day cycle beyond cycle 9 Dexamethasone- 20 mg on the day of Bortezomib administration","id":"EG000","otherNumAffected":19,"otherNumAtRisk":19,"seriousNumAffected":8,"seriousNumAtRisk":19,"title":"ASP7487, Velcade, Dexamethasone"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE v4.03","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":19}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v4.03","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":19}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v4.03","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":19}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v4.03","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":19}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.03","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":19}],"term":"Pneumonia/influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.03","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":19}],"term":"Creatinine Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.03","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":19}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE v4.03","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":19}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE v4.03","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":19}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE v4.03","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":19}],"term":"Neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.03","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":19}],"term":"Cough"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Alanine Aminitransferase Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Occured in the same patient with increased Alanine Aminotransferase","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Asparate Aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"not related to study drug","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE v4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Delirium"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.03","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19,"numEvents":2}],"term":"Lung infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Death due to progressive disease","organSystem":"General disorders","sourceVocabulary":"CTCAE v4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Death due to multiple myeloma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Probably related to bortezomib","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE v4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE v4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v4.03","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19,"numEvents":2}],"term":"fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"dyspnea"}],"timeFrame":"4 years and 10 months. This period includes the time period from study activation to the final data analysis, the results of which are presented here.The adverse event data was collected from study activation on 3 Oct 2012 up to 22 Aug 2017."}