{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"73"}]}],"title":"Any adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"64"}]}],"title":"Grade 3-4 adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"51"}]}],"title":"AE related to pomalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"33"}]}],"title":"Grade 3-4 AE related to pomalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"19"}]}],"title":"Grade 5 AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"52"}]}],"title":"≥1 Serious AE (SAE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"}]}],"title":"≥1 SAE related to pomalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}],"title":"≥1 SAE leading to stopping pomalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"}]}],"title":"≥AE leading to discontinuation of pomalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"≥1 study drug related AE leading to stopping POM"},{"categories":[{"measurements":[{"groupId":"OG000","value":"11"}]}],"title":"≥1 AE leading to reduction of pomalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"}]}],"title":"≥1 study drug related AE leading to reducing POM"},{"categories":[{"measurements":[{"groupId":"OG000","value":"41"}]}],"title":"≥1 AE leading to interruption of pomalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"25"}]}],"title":"≥ 1 study drug related interruption of POM"}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"}],"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:\n\n* Results in death;\n* Is life-threatening;\n* Requires or prolongs existing inpatient hospitalization;\n* Results in persistent or significant disability/incapacity;\n* Is a congenital anomaly/birth defect;\n* Constitutes an important medical event.\n\nThe 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):\n\nGrade 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":"Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity","id":"OG000","title":"Pomalidomide"}],"paramType":"NUMBER","populationDescription":"Safety population includes all participants who received at least one dose of study drug.","reportingStatus":"POSTED","timeFrame":"From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.","title":"Number of Participants With Adverse Events and Type of Adverse Events","type":"SECONDARY","unitOfMeasure":"participants"}