{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"298"},{"groupId":"OG001","value":"149"},{"groupId":"OG002","value":"11"}]}],"title":"Any adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"266"},{"groupId":"OG001","value":"127"},{"groupId":"OG002","value":"8"}]}],"title":"Grade 3-4 adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"251"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"11"}]}],"title":"AE related to pomalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"205"},{"groupId":"OG001","value":"115"},{"groupId":"OG002","value":"5"}]}],"title":"AE related to dexamethasone"},{"categories":[{"measurements":[{"groupId":"OG000","value":"271"},{"groupId":"OG001","value":"115"},{"groupId":"OG002","value":"11"}]}],"title":"AE related to either study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"199"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"6"}]}],"title":"Grade 3-4 AE related to pomalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"114"},{"groupId":"OG001","value":"70"},{"groupId":"OG002","value":"2"}]}],"title":"Grade 3-4 AE related to dexamethasone"},{"categories":[{"measurements":[{"groupId":"OG000","value":"212"},{"groupId":"OG001","value":"70"},{"groupId":"OG002","value":"6"}]}],"title":"Grade 3-4 AE related to either study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"21"},{"groupId":"OG002","value":"1"}]}],"title":"Grade 5 adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"195"},{"groupId":"OG001","value":"80"},{"groupId":"OG002","value":"4"}]}],"title":"Serious adverse events (SAEs)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"89"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":"SAE related to pomalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"36"},{"groupId":"OG002","value":"0"}]}],"title":"SAE related to dexamethasone"},{"categories":[{"measurements":[{"groupId":"OG000","value":"98"},{"groupId":"OG001","value":"36"},{"groupId":"OG002","value":"1"}]}],"title":"SAE related to either study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":"SAE leading to discontinuation of pomalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"1"}]}],"title":"SAE leading to discontinuation of dexamethasone"},{"categories":[{"measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"1"}]}],"title":"SAE leading to discontinuation of either study dru"},{"categories":[{"measurements":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":"AE leading to discontinuation of pomalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"1"}]}],"title":"AE leading to discontinuation of dexamethasone"},{"categories":[{"measurements":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"1"}]}],"title":"AE leading to discontinuation of either study drug"}],"denoms":[{"counts":[{"groupId":"OG000","value":"300"},{"groupId":"OG001","value":"150"},{"groupId":"OG002","value":"11"}],"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":"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.","id":"OG000","title":"Pomalidomide Plus Low-Dose Dexamethasone"},{"description":"Participants received 40 mg dexamethasone (participants \\> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression, or until cross-over to pomalidomide. Data are up to the time of cross-over.","id":"OG001","title":"High-Dose Dexamethasone"},{"description":"Participants initially randomized to high-dose dexamethasone (HD-Dex) crossed over to receive 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle, with or without low-dose dexamethasone (40 mg for participants ≤ 75 years or 20 mg for participants \\> 75 years of age, administered orally once per day on Days 1, 8, 15, and 22 of each 28-day cycle) at the discretion of the investigator. Data include AEs that occurred after cross-over to pomalidomide.","id":"OG002","title":"HD-Dex / Pomalidomide"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety population (all randomized participants who received at least one dose of study drug (either pomalidomide or dexamethasone)).","reportingStatus":"POSTED","timeFrame":"From first dose of study drug through to 30 days after the last dose as of the end of the study (29 August 2017); maximum time on treatment was 297, 269, and 239 weeks in the Pomalidomide + LD-Dex, HD-Dex, and cross-over groups respectively.","title":"Number of Participants With Adverse Events (AEs)","type":"SECONDARY","unitOfMeasure":"Participants"}