{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"25"}]}],"title":"Any Adverse Event (AE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"25"}]}],"title":"Drug-Related AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"22"}]}],"title":"Grade 3-4 Adverse Event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"21"}]}],"title":"Drug-Related Grade 3-4 AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"}]}],"title":"Serious Adverse Event (SAE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"}]}],"title":"Drug-Related SAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"AE Leading to Study Drug Discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Related AE Leading to Len/Dex Discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"17"}]}],"title":"AE leading to dose reduction or interruption"},{"categories":[{"measurements":[{"groupId":"OG000","value":"16"}]}],"title":"Related AE leading to dose reduction/interruption"}],"denoms":[{"counts":[{"groupId":"OG000","value":"25"}],"units":"Participants"}],"description":"A TEAE was defined as any AE that started on or after the first dose of study drug, and within End of Study (EOS) (28 days after the last dose of study drug received). A serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect; or constitutes an important medical event. The intensity of AEs were graded 1 to 5 according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. For all other AEs not described in the CTCAE criteria, the intensity was assessed by the investigator as mild grade (Grade 1), moderate (grade 2), severe (grade 3), life-threatening (grade 4) or death (grade 5)","groups":[{"description":"Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance \\<60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.","id":"OG000","title":"Lenalidomide and Dexamethasone"}],"paramType":"NUMBER","populationDescription":"Safety population included all 25 participants who received at least one dose of study drug.","reportingStatus":"POSTED","timeFrame":"Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks","title":"Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)","type":"PRIMARY","unitOfMeasure":"participants"}