{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"3"}]}],"title":"No dose modification"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"0"}]}],"title":"One dose modification"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"3"}]}],"title":"Two or more dose modifications"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"6"},{"groupId":"OG005","value":"6"}],"units":"Participants"}],"description":"An adverse experience (AE) was 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 was temporally associated with the use of the sponsor's product, was also an adverse experience.","groups":[{"description":"Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).\n\nBortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle).","id":"OG000","title":"Vorinostat 200 mg + Bortezomib 0.7 mg/m^2"},{"description":"Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).\n\nBortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle).","id":"OG001","title":"Vorinostat 200 mg + Bortezomib 0.9 mg/m^2"},{"description":"Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).\n\nBortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).","id":"OG002","title":"Vorinostat 300 mg + Bortezomib 1.3 mg/m^2"},{"description":"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).\n\nBortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).","id":"OG003","title":"Vorinostat 400 mg + Bortezomib 0.9 mg/m^2"},{"description":"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).\n\nBortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).","id":"OG004","title":"Vorinostat 400 mg + Bortezomib 1.1 mg/m^2"},{"description":"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).\n\nBortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).","id":"OG005","title":"Vorinostat 400 mg + Bortezomib 1.3 mg/m^2"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"Day 1 to disease progression, toxicity, or death, assessed up to 29 months","title":"Number of Participants With Dose Modifications of Either Vorinostat or Bortezomib Due to Adverse Experiences (AEs) After Treatment With Study Drug","type":"SECONDARY","unitOfMeasure":"Participants"}