{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"272"},{"groupId":"OG001","value":"240"}]}],"title":"Grade 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"108"},{"groupId":"OG001","value":"85"}]}],"title":"Grade 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"17"}]}],"title":"Grade 5"}],"denoms":[{"counts":[{"groupId":"OG000","value":"315"},{"groupId":"OG001","value":"320"}],"units":"Participants"}],"description":"An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. Grades come from the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Per protocol, clinical and laboratory AEs are presented as a combined total for each grade.","groups":[{"description":"Participants will receive vorinostat four 100 mg capsules (400 mg total) orally 0-30 minutes after a meal on Days 1 through 14 of a 21-day treatment cycle and bortezomib 1.3 mg/m\\^2 by intravenous injection on Days 1, 4, 8, and 11 of a 21-day treatment cycle.","id":"OG000","title":"Vorinostat + Bortezomib"},{"description":"Participants will receive four placebo capsules orally 0-30 minutes after a meal on Days 1 through 14 of a 21-day treatment cycle and bortezomib 1.3 mg/m\\^2 by intravenous injection on Days 1, 4, 8, and 11 of a 21-day treatment cycle.","id":"OG001","title":"Placebo + Bortezomib"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The analysis population includes all randomized participants who received ≥1 dose of study medication.","reportingStatus":"POSTED","timeFrame":"Up to 722 days","title":"Number of Participants With Grade 3-5 Clinical or Laboratory Adverse Events (AEs)","type":"SECONDARY","unitOfMeasure":"Participants"}