{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"23"}]}],"title":"SAE Grade 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"1"}]}],"title":"SAE Grade 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"SAE Grade 5"}],"denoms":[{"counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"17"}],"units":"Participants"}],"description":"Type, frequency, severity and timing of adverse events and their relationship to combination therapy with lenalidomide plus dexamethasone.\n\nSAE Grade 3 indicates a severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization; disabling; limiting self care ADL SAE Grade 4 indicates a life-threatening consequences; urgent intervention indicated.\n\nSAE Grade 5 Death related to AE.","groups":[{"description":"Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle\n\nLenalidomide 25mg: Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle","id":"OG000","title":"Lenalidomide 25mg"},{"description":"Subjects will receive oral lenalidomide 15mg once daily for days 1-21 out of a 28 cycle\n\nLenalidomide 15mg: Subjects will receive oral lenalidomide 15 mg once daily for 1-21 of a 28 day cycle.","id":"OG001","title":"Lenalidomide 15mg"}],"paramType":"NUMBER","populationDescription":"33","reportingStatus":"POSTED","timeFrame":"Data was collected for each subject for the duration of the participation in the study, ranging between 75 to 475 days.","title":"Serious Adverse Events","type":"PRIMARY","unitOfMeasure":"Events"}