{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"28"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"142"}],"units":"Participants"}],"description":"An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who discontinued study treatment due to an AE were reported.","groups":[{"description":"Participants receive vorinostat 400 mg, orally, once daily (QD) on Days 1-14 of each 21-day treatment cycle and bortezomib 1.3mg/m\\^2 intravenous (IV) injection QD on Days 1, 4, 8 and 11 of each 21-day treatment cycle for up to 26 cycles. Participants with progressive disease (PD) after 2 cycles of treatment or no change (NC) after 4 cycles of treatment receive additional treatment of Dexamethasone, 20 mg of total daily dose, orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day treatment cycle for up to 26 cycles. Eligible participants could receive additional treatment on an extension.","id":"OG000","title":"Vorinostat + Bortezomib"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All participants who received at least one dose of study treatment","reportingStatus":"POSTED","timeFrame":"Up to approximately 18 months","title":"Number of Participants Who Discontinued Study Treatment Due to an AE","type":"SECONDARY","unitOfMeasure":"Participants"}