{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"17"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"17"}],"units":"Participants"}],"description":"An 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 of a pre-existing condition which is temporally associated with the use of the Sponsor's product is also an AE. An AE was considered related to a drug as determined by the investigator based on exposure (evidence of exposure to drug), time course (time of AE onset versus drug-induced effect), likely cause (AE etiology related or un-related to drug), de-challenge (drug dose reduction/discontinuation) or re-challenge (drug re-exposure). Per protocol participants experiencing drug-related AEs were analyzed at the time of the protocol-specified final statistical analysis with a 3-September (Sep)-2012 data cut-off. The number of participants experiencing drug-related AEs is reported here for all participants who got ≥1 dose of study drug.","groups":[{"description":"Participants received vorinostat 300 mg orally once-daily (QD) on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.","id":"OG000","title":"Level 1: Vorinostat 300 mg + Lenalidomide 10 mg"},{"description":"Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.","id":"OG001","title":"Level 2: Vorinostat 400 mg + Lenalidomide 10 mg"},{"description":"Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 15 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.","id":"OG002","title":"Level 3: Vorinostat 400 mg + Lenalidomide 15 mg"},{"description":"Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 20 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.","id":"OG003","title":"Level 4: Vorinostat 400 mg + Lenalidomide 20 mg"},{"description":"Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 25 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle. Treatment continued until progressive disease or unacceptable toxicity.","id":"OG004","title":"Level 5: Vorinostat 400 mg + Lenalidomide 25 mg"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All participants who received ≥1 dose of study treatment.","reportingStatus":"POSTED","timeFrame":"Up to ~55 months (through pre-specified final statistical analysis cut-off date of 3-Sep-2012)","title":"Number of Participants Experiencing Drug-Related Adverse Events (AEs)","type":"SECONDARY","unitOfMeasure":"Participants"}