{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"32"}]}],"title":"At least 1 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"30"}]}],"title":"At least 1 drug-related TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"28"}]}],"title":"At least 1 Romidepsin-related TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"30"}]}],"title":"At least 1 Bortezomib-related TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"28"}]}],"title":"At least 1 >=Grade 3 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}],"title":"At least 1 Grade 4 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"14"}]}],"title":"At least 1 serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}],"title":"At least 1 TEAE leading to discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"At least 1 TEAE leading to death"}],"denoms":[{"counts":[{"groupId":"OG000","value":"32"}],"units":"Participants"}],"description":"Counts of participants with TEAEs, and subset by relation to drug, grade of severity, serious, TEAEs leading to discontinuation or leading to death. AEs were graded for severity according to the National Cancer Institute Common Terminology Criteria (NCI CTCAE), V 3.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe (prevents normal everyday activities); Grade 4: Life-threatening or disabling; Grade 5: Death.","groups":[{"description":"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.\n\nPatients were treated to a maximum response plus two additional cycles or a maximum of eight cycles.","id":"OG000","title":"Romidepsin + Bortezomib"}],"paramType":"NUMBER","populationDescription":"Safety population of participants who took at least one dose of drug.","reportingStatus":"POSTED","timeFrame":"up to 9 months","title":"Participants With Treatment-emergent Adverse Events (TEAEs)","type":"SECONDARY","unitOfMeasure":"participants"}