{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"105"},{"groupId":"OG001","value":"120"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"318"}],"units":"Participants"}],"description":"A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.","groups":[{"description":"Velcade (bortezomib) 1.3 milligram/meter per square (mg/m\\^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.","id":"OG000","title":"Velcade (Bortezomib) Monotherapy"},{"description":"Velcade (bortezomib) 1.3 mg/m\\^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m\\^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.","id":"OG001","title":"Doxil/Caelyx Plus Velcade (Bortezomib)"}],"paramType":"NUMBER","populationDescription":"Safety population included all the participants who received at least one dose of study drug. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.","reportingStatus":"POSTED","timeFrame":"Up to 1 year and 11 months (From date of first participant randomization [20 December 2004] to cut-off date for safety update (28 November 2006)","title":"Number of Participants With Serious Adverse Events (SAEs)","type":"SECONDARY","unitOfMeasure":"Participants"}