{"eventGroups":[{"description":"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.\n\nMAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.\n\nofatumumab: Given IV\n\nbortezomib: Given SC\n\nlaboratory biomarker analysis: Correlative studies","id":"EG000","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":0,"seriousNumAtRisk":3,"title":"Treatment (Monoclonal Antibody Therapy)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":2}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Iritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Vision blurred"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3,"numEvents":2}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":2}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Gait disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Infusion site rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Injection site erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Injection site joint redness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Furuncle"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3,"numEvents":5}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Procedural pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Thermal burn"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":4}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Hypernatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Hyperuricaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":3}],"term":"Hypoglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Tumour flare"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":2}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Peroneal nerve palsy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Presyncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Sensory loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Scrotal swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Acne"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":2}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Flushing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Hypotension"}]}