{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"26"}]}],"title":"Any adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"25"}]}],"title":"TEAE related to study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"25"}]}],"title":"TEAE related to Lenalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"20"}]}],"title":"TEAE related to Dexamethasone"},{"categories":[{"measurements":[{"groupId":"OG000","value":"18"}]}],"title":"Grade 3-4 adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"}]}],"title":"Grade 3-4 adverse event related to any study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"}]}],"title":"Grade 3-4 adverse event related to Lenalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"Grade 3-4 adverse event related to Dexamethasone"},{"categories":[{"measurements":[{"groupId":"OG000","value":"11"}]}],"title":"Serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"}]}],"title":"Serious TEAE related to any study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"}]}],"title":"Serious TEAE related to Lenalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"Serious TEAE related to Dexamethasone"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"TEAE leading to discontinuation of either drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"TEAE leading to discontinuation of lenalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"TEAE leading to discontinuation of dexamethasone"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"Related TEAE discontinuation of either drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"Related TEAE discontinuation of lenalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Related TEAE discontinuation of dexamethasone"}],"denoms":[{"counts":[{"groupId":"OG000","value":"26"}],"units":"Participants"}],"description":"An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0): 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 orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.\n\nDexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.","id":"OG000","title":"Lenalidomide Plus Dexamethasone"}],"paramType":"NUMBER","populationDescription":"Safety population includes all participants who received at least one dose of study drug.","reportingStatus":"POSTED","timeFrame":"From first dose of study drug treatment through to 28 days after the last dose, until the data cut-off date of 15 July 2014; median treatment duration was 60 weeks","title":"Number of Participants With Adverse Events","type":"SECONDARY","unitOfMeasure":"participants"}