{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"176"},{"groupId":"OG001","value":"175"}]}],"title":"≥ 1 Adverse Event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"105"},{"groupId":"OG001","value":"79"}]}],"title":"≥ 1 Serious Adverse Event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"31"}]}],"title":"≥ 1 AE leading to study drug discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"137"},{"groupId":"OG001","value":"100"}]}],"title":"≥ 1 AE leading to dose reduction or interruption"},{"categories":[{"measurements":[{"groupId":"OG000","value":"160"},{"groupId":"OG001","value":"151"}]}],"title":"≥ 1 Drug-Related Adverse Event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"30"}]}],"title":"≥ 1 Drug-Related Serious Adverse Event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"20"}]}],"title":"≥Death within ≤ 30 days of last dose of study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"176"},{"groupId":"OG001","value":"175"}]}],"title":"≥ 1 Grade 1 or Higher Adverse Event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"168"},{"groupId":"OG001","value":"167"}]}],"title":"≥ 1 Grade 2 or Higher Adverse Event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"146"},{"groupId":"OG001","value":"119"}]}],"title":"≥ 1 Grade 3 or Higher Adverse Event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"37"}]}],"title":"≥ 1 Grade 4 or Higher Adverse Event"}],"denoms":[{"counts":[{"groupId":"OG000","value":"176"},{"groupId":"OG001","value":"175"}],"units":"Participants"}],"description":"An AE is any sign, symptom, illness, or diagnosis that appears or worsens during the course of the study. Treatment-emergent AEs (TEAEs) are any AE occurring or worsening on or after the first treatment of the study drug and within 30 days after the last cycle end date of study drug. A serious AE = any AE which results in death; is life-threatening; requires or prolongs existing inpatient hospitalization; results in persistent or significant disability is a congenital anomaly/birth defect; constitutes an important medical event.\n\nThe severity of AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE, Version 2.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required); Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death.","groups":[{"description":"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.\n\nDexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.","id":"OG000","title":"Lenalidomide Plus Dexamethasone"},{"description":"Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days. Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.\n\nAfter the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression.","id":"OG001","title":"Placebo Plus Dexamethasone"}],"paramType":"NUMBER","populationDescription":"The safety population includes all participants who received at least one dose of study drug regimen","reportingStatus":"POSTED","timeFrame":"From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 25 June 2013; up to 90 months","title":"Number of Participants With Adverse Events (AE)","type":"SECONDARY","unitOfMeasure":"participants"}