{"description":"CTCAE version 5.0","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":6,"description":"Subjects with relapsed or refractory multiple myeloma receiving the study treatment.","id":"EG000","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":0,"seriousNumAtRisk":6,"title":"Experimental: Single Arm"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6}],"term":"Anemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Watering eyes"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Bloating"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":6}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Dry mouth"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Gastrointestinal disorders - Other, specify"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Edema limbs"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Flu like symptoms"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Non-cardiac chest pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Allergic reaction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Infections and infestations - Other, specify"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6}],"term":"Upper respiratory infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Infusion related reaction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":6}],"term":"Lymphocyte count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":6}],"term":"Neutrophil count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6}],"term":"Platelet count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":6}],"term":"White blood cell decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Hyperglycemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6}],"term":"Hypernatremia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6}],"term":"Hypoalbuminemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6}],"term":"Hypocalcemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6}],"term":"Hypokalemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Hypophosphatemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Back pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Muscle cramp"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Musculoskeletal and connective tissue disorder - Other, specify"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Myalgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Amnesia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Dizziness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Dysgeusia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Tremor"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Anxiety"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Insomnia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Urinary urgency"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Dyspnea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Pruritus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"\"Skin and subcutaneous tissue disorders - Other, specify\""}],"timeFrame":"Up to a maximum of 383 days (including 30 days after the last treatment). Protocol treatment duration is variable, and continues until disease progression, unacceptable toxicity, intercurrent illness, pregnancy, subject withdrawal, investigator decision, or loss to follow-up."}