{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"36"}]}],"title":"Any 1 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"33"}]}],"title":"TEAE related to any study drugs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"33"}]}],"title":"TEAE related to Pomalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"27"}]}],"title":"TEAE related to Dexamethasone(Dex)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"33"}]}],"title":"TEAE with ≥ Grade (GR) 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"30"}]}],"title":"≥ 1TEAE ≥ GR 3 related to any study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"30"}]}],"title":"TEAE ≥ GR 3 related to Pomalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"11"}]}],"title":"TEAE ≥ GR 3 related to Dexamethasone"},{"categories":[{"measurements":[{"groupId":"OG000","value":"16"}]}],"title":"≥ 1 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 Pomalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}],"title":"Serious TEAE related to Dexamethasone"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}],"title":"TEAE leading to stopping of any study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}],"title":"TEAE leading to discontinuation of Pomalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}],"title":"TEAE leading to discontinuation of Dexamethasone"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"Related TEAE leading to stopping of study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"Related TEAE leading to stopping of Pomalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"Related TEAE leading to stopping Dexamethasone"},{"categories":[{"measurements":[{"groupId":"OG000","value":"19"}]}],"title":"TEAE leading to dose reduction of any study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"}]}],"title":"TEAE leading to dose reduction of Pomalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"}]}],"title":"TEAE leading to dose reduction of Dexamethasone"},{"categories":[{"measurements":[{"groupId":"OG000","value":"20"}]}],"title":"TEA leading to dose interruption of any study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"18"}]}],"title":"TEAE leading to dose interruption of Pomalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"11"}]}],"title":"TEAE leading to dose interruption of Dexamethasone"},{"categories":[{"measurements":[{"groupId":"OG000","value":"18"}]}],"title":"Related TEAE leading to dose reduction of any drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"}]}],"title":"Related TEAE causing a dose reduction Pomalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"14"}]}],"title":"≥1 related TEAE causing a dose reduction: Dex"},{"categories":[{"measurements":[{"groupId":"OG000","value":"16"}]}],"title":"Related TEAE leading to interruption of drugs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"}]}],"title":"Related TEAE causing an interruption Pomalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"}]}],"title":"Related TEAE causing an interruption to Dex"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"TEAE Grade 5"}],"denoms":[{"counts":[{"groupId":"OG000","value":"36"}],"units":"Participants"}],"description":"Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) were those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above. Treatment Emergent Adverse Event (TEAE) was defined as any AE occurring on or after the first treatment of the study medication and within 28 days after the last dose.","groups":[{"description":"Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \\> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression or pomalidomide discontinuation for any reason.","id":"OG000","title":"Pomalidomide Plus Dexamethasone"}],"paramType":"NUMBER","populationDescription":"Safety population includes all participants who took at least one dose of study medication.","reportingStatus":"POSTED","timeFrame":"From first dose of study drug to final data cut-off date of 25 Sept 2015, maximum duration on treatment was 80.9 weeks","title":"Number of Participants With Adverse Events","type":"SECONDARY","unitOfMeasure":"participants"}