{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Leukopenia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"}]}],"title":"Lymphopenia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Neutropenia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Thrombocytopenia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Cataract"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Fatigue"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Upper respiratory infection"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Anxiety"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Pain in extremity"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Sinus bradycardia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"Hyperglycemia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"Hypophosphatemia"}],"denoms":[{"counts":[{"groupId":"OG000","value":"40"}],"units":"Participants"}],"description":"All grade 3 and above treatment-related adverse events (AEs) during bortezomib/dexamethasone treatment cycles.","groups":[{"description":"Patients receive high-dose melphalan IV 200mg/m\\^2 over 30 minutes on days -2 and -1 and undergo autologous peripheral blood stem cell transplantation (Minimum dose of 2 X 10(6) CD34 + cells/kg ) on day 0. Patients receive filgrastim 5ug/kg IV or SQ beginning on day 5 and continuing until blood counts recover. Beginning 4 to 8 weeks after transplantation, patients receive maintenance therapy comprising 1.3 mg/m\\^2 of bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive 40mg of oral dexamethasone on days 1 to 4. Treatment with dexamethasone repeats every month for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of bortezomib, patients receive 50mg/day of oral thalidomide once daily until disease progression.","id":"OG000","title":"Treatment (Stem Cell Transplant, Maintenance Treatment)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Five patients did not start the maintenance phase of the study because of neurotoxicity (n=3), thrombocytopenia (n=1), or withdrawal of consent (n=1).","reportingStatus":"POSTED","timeFrame":"After 4 months of maintenance therapy","title":"Number of Participants With Adverse Events","type":"PRIMARY","unitOfMeasure":"Participants"}