{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"227"},{"groupId":"OG001","value":"243"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"228"},{"groupId":"OG001","value":"246"}],"units":"Participants"}],"description":"Number of patients with TEAEs, including clinical laboratory and vital signs abnormalities, as assessed by CTCAE v4.0 are presented. No formal statistical analysis was performed for safety endpoints.","groups":[{"description":"Melflufen 40 mg i.v. on Day 1 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue.\n\nMelflufen: Intravenous infusion\n\nDexamethasone: Oral tablets","id":"OG000","title":"Arm A: Melflufen+Dexamethasone"},{"description":"Pomalidomide 4 mg orally daily on Days 1 to 21 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue.\n\nPomalidomide: Oral capsules\n\nDexamethasone: Oral tablets","id":"OG001","title":"Arm B: Pomalidomide+Dexamethasone"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety Analysis Set (all patients that have received at least one dose of study drug in either Arm A or Arm B).","reportingStatus":"POSTED","timeFrame":"From start of dosing until 30 days after the last dose of study treatment, up to the data cutoff date of 03 Feb 2023 (ie, assessed up to approximately 67 months). Median duration of study treatment was 25.2 and 22.1 weeks for Arm A and B, respectively.","title":"Safety and Tolerability: Number of Patients With Treatment-emergent Adverse Events (TEAEs), Including Clinical Laboratory and Vital Signs Abnormalities, as Assessed by CTCAE v4.0","type":"SECONDARY","unitOfMeasure":"Participants"}