{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"673"}]}],"title":"≥ TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"527"}]}],"title":"≥ 1 TEAE Related to Pomalidomide (POM)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"448"}]}],"title":"≥ 1 TEAE Related to LD-Dex"},{"categories":[{"measurements":[{"groupId":"OG000","value":"575"}]}],"title":"≥ 1 TEAE Related to Either POM or LD-Dex"},{"categories":[{"measurements":[{"groupId":"OG000","value":"606"}]}],"title":"≥ 1 Grade (Gr) 3 or 4 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"417"}]}],"title":"≥ 1 Gr 3 or 4 TEAE Related to (R/T) POM"},{"categories":[{"measurements":[{"groupId":"OG000","value":"226"}]}],"title":"≥ 1 Gr 3 or 4 TEAE R/T LD-Dex"},{"categories":[{"measurements":[{"groupId":"OG000","value":"448"}]}],"title":"≥ 1 Gr 3 or 4 TEAE R/T Either POM or LD-Dex"},{"categories":[{"measurements":[{"groupId":"OG000","value":"127"}]}],"title":"≥ 1 Grade 5 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"14"}]}],"title":"≥ 1 Grade 5 TEAE R/T POM"},{"categories":[{"measurements":[{"groupId":"OG000","value":"16"}]}],"title":"≥ 1 Grade 5 TEAE R/T LD-Dex"},{"categories":[{"measurements":[{"groupId":"OG000","value":"18"}]}],"title":"≥ 1 Grade 5 TEAE R/T either POM or LD-Dex"},{"categories":[{"measurements":[{"groupId":"OG000","value":"448"}]}],"title":"≥ 1 Serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"187"}]}],"title":"≥ 1 Serious TEAE R/T POM"},{"categories":[{"measurements":[{"groupId":"OG000","value":"146"}]}],"title":"≥ 1 Serious TEAE R/T LD-Dex"},{"categories":[{"measurements":[{"groupId":"OG000","value":"215"}]}],"title":"≥ 1 Serious TEAE R/T Either POM or LD-Dex"},{"categories":[{"measurements":[{"groupId":"OG000","value":"36"}]}],"title":"≥ 1 Serious TEAE Leading to (L/T)Stopping of POM"},{"categories":[{"measurements":[{"groupId":"OG000","value":"34"}]}],"title":"≥ 1 Serious TEAE L/T Stopping of LD-Dex"},{"categories":[{"measurements":[{"groupId":"OG000","value":"37"}]}],"title":"≥1 Serious TEAE L/T Stopping either POM or LD-Dex"},{"categories":[{"measurements":[{"groupId":"OG000","value":"54"}]}],"title":"≥ 1 TEAE L/T to Stopping of POM"},{"categories":[{"measurements":[{"groupId":"OG000","value":"61"}]}],"title":"≥ 1 TEAE L/T to Stopping of LD-DEX"},{"categories":[{"measurements":[{"groupId":"OG000","value":"63"}]}],"title":"≥ 1 TEAE L/T to Stopping of Either POM or LD-DEX"},{"categories":[{"measurements":[{"groupId":"OG000","value":"30"}]}],"title":"≥1 Study Drug Related TEAE (L/T) Stopping POM"},{"categories":[{"measurements":[{"groupId":"OG000","value":"19"}]}],"title":"≥1 Study Drug Related TEAE L/T Stopping LD-Dex"},{"categories":[{"measurements":[{"groupId":"OG000","value":"38"}]}],"title":"≥1 Drug Related TEAE L/T Stopping LD-Dex or POM"},{"categories":[{"measurements":[{"groupId":"OG000","value":"164"}]}],"title":"≥ 1 TEAE L/T to Reduction (R/D) of POM"},{"categories":[{"measurements":[{"groupId":"OG000","value":"150"}]}],"title":"≥ 1 TEAE L/T to R/D of LD-DEX"},{"categories":[{"measurements":[{"groupId":"OG000","value":"244"}]}],"title":"≥ 1 TEAE L/T to R/D of Either POM or LD-DEX"},{"categories":[{"measurements":[{"groupId":"OG000","value":"142"}]}],"title":"≥ 1 Study Drug Related TEAE L/T to R/D of POM"},{"categories":[{"measurements":[{"groupId":"OG000","value":"135"}]}],"title":"≥ 1 Study Drug Related TEAE L/T to R/D of LD-DEX"},{"categories":[{"measurements":[{"groupId":"OG000","value":"224"}]}],"title":"≥1 StudyDrug Related TEAE L/T to R/D POM or LD-DEX"},{"categories":[{"measurements":[{"groupId":"OG000","value":"455"}]}],"title":"≥ 1 TEAE L/T to Interruption (I/R) of POM"},{"categories":[{"measurements":[{"groupId":"OG000","value":"434"}]}],"title":"≥ 1 TEAE L/T to I/R of LD-DEX"},{"categories":[{"measurements":[{"groupId":"OG000","value":"470"}]}],"title":"≥ 1 TEAE L/T to I/R of either POM or LD-DEX"},{"categories":[{"measurements":[{"groupId":"OG000","value":"294"}]}],"title":"≥ 1 Study Drug Related TEAE L/T to I/R of POM"},{"categories":[{"measurements":[{"groupId":"OG000","value":"185"}]}],"title":"≥ 1 Study Drug Related TEAE L/T to I/R of LD-DEX"},{"categories":[{"measurements":[{"groupId":"OG000","value":"333"}]}],"title":"≥1 StudyDrug Related TEAE L/T to I/R POM or LD-DEX"}],"denoms":[{"counts":[{"groupId":"OG000","value":"676"}],"units":"Participants"}],"description":"An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, regardless of etiology. Any worsening (i.e., any significant adverse change in the frequency or intensity of a pre- existing condition) was considered an AE. The severity of AEs were graded based on the symptoms according to version 4.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events. Second primary malignancies were monitored as events of interest and considered as part of the assessment of AEs.\n\nA SAE = AE occurring at any dose that:\n\n* Results in death;\n* Is life-threatening\n* Requires inpatient hospitalization or prolongation of existing hospitalization\n* Results in persistent or significant disability/incapacity\n* Is a congenital anomaly/birth defect","groups":[{"description":"Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (\\> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.","id":"OG000","title":"Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The safety population includes all enrolled participants who received at least one dose of the IP.","reportingStatus":"POSTED","timeFrame":"From the first dose of study treatment up to 28 days following the last dose of study treatment. The median duration of treatment with pomalidomide and LD-dex was 21.4 weeks.","title":"Number of Participants With Treatment Emergent Adverse Events (TEAE)","type":"PRIMARY","unitOfMeasure":"Participants"}