{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"38"}]}],"title":"Participants with Adverse Events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"}]}],"title":"Deaths"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"On treatment deaths"},{"categories":[{"measurements":[{"groupId":"OG000","value":"17"}]}],"title":"Serious Adverse Events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"Study-drug-related Serious Adverse Events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"}]}],"title":"Adverse Events Leading to discontinuation"}],"denoms":[{"counts":[{"groupId":"OG000","value":"38"}],"units":"Participants"}],"description":"Adverse Event (AE) are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.","groups":[{"description":"Participants received panobinostat 20 mg orally OD, three times a week on days: 1, 3 and 5, then 8, 10 and 12, then 15, 17 and 19 of each cycle, as part of a 3-week (21 days) treatment cycle. Participants could continue treatment until disease progression or unacceptable toxicity.","id":"OG000","title":"Panobinostat"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The analysis was performed on Safety population consisted of all participants who had received at least one dose of study medication and had one valid post-baseline assessment.","reportingStatus":"POSTED","timeFrame":"From Start of the Study up to 57 Weeks approximately.","title":"Safety and Tolerability","type":"SECONDARY","unitOfMeasure":"Participants"}