{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"34"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"45"}],"units":"Participants"}],"description":"Number of patients with any grade or severe, defined as ≥ grade 3 by Common Terminology Criteria for Adverse Events (CTCAE) v4.0, adverse events as a measure of safety","groups":[{"description":"Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle.","id":"OG000","title":"Bortezomib+Melphalan+Prednisone"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"At any time during the study and up to 30 days after stopping the study drug","title":"Number of Patients With Any Grade or Severe Adverse Event","type":"SECONDARY","unitOfMeasure":"participants"}