{"description":"Two participants were removed from the study before they underwent a collection on the Spectra Optia Apheresis System and were not at risk.","eventGroups":[{"description":"Multiple myeloma patients requiring myeloablative therapy and a first autologous hematopoetic stem cell transplant.","id":"EG000","otherNumAffected":7,"otherNumAtRisk":30,"seriousNumAffected":2,"seriousNumAtRisk":30,"title":"Patients With Multiple Myeloma"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":30,"numEvents":5}],"term":"Citrate Reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Fever post ahpheresis, pre-apheresis and product cultures negative.Patient recovered.Unrelated to the device.\n\nFever/chills post apheresis, preapheresis blood culture positive.Patient recovered.Unrelated to the device.","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30,"numEvents":2}],"term":"Fever"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Blood cultures were negative but patient was hospitalized for antibiotic administration. Patient recovered and event judged to unrelated to the device.","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Fever and hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Required inpatient hospitalization and antibiotics. Patient recovered. Unrelated to the device.","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Pneumonia/Sepsis"}],"timeFrame":"During stem cell collection (3-6 hours) and following reinfusion of collected stem cell product until neutrophil recovery (1-28 days)."}