{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"151"},{"groupId":"OG001","value":"70"}]}],"title":"≥ 1 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"26"}]}],"title":"≥ 1 Suspected Related TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"23"}]}],"title":"≥ 1 Serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"0"}]}],"title":"≥ 1 Suspected Related Serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"4"}]}],"title":"≥ 1 TEAE CTCAE Toxicity Grade (GR) 5"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"≥ 1 Suspected Related TEAE With CTCAE GR 5"},{"categories":[{"measurements":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"34"}]}],"title":"≥ 1 TEAE with CTCAE GR 3 or 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"3"}]}],"title":"≥ 1 Suspected Related TEAE With CTCAE GR 3 or 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"4"}]}],"title":"≥ 1 TEAE Leading to Dose Interruption"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"0"}]}],"title":"≥ 1 TEAE Leading to Dose Reduction"},{"categories":[{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"6"}]}],"title":"≥ 1 TEAE Leading to Study Drug Discontinuation"}],"denoms":[{"counts":[{"groupId":"OG000","value":"153"},{"groupId":"OG001","value":"76"}],"units":"Participants"}],"description":"The outcome measure describes the number of participants who experienced different types of Treatment-emergent adverse events (TEAEs).\n\nTEAEs were defined as Adverse Events (AEs) that started on or after the day of the first dose and on or before 42 days after the last dose of IP.\n\nThe investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event. The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 4.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death.","groups":[{"description":"Luspatercept 1.0 mg/Kg SC on Day 1 of each 21-day treatment cycle","id":"OG000","title":"Luspatercept"},{"description":"Placebo (Volume equivalent to experimental arm) SC on Day 1 of each 21-day treatment cycle","id":"OG001","title":"Placebo"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All treated participants","reportingStatus":"POSTED","timeFrame":"From date of first dose up to 42 days after the last dose (up to approximately 83 weeks)","title":"Number of Participants With Treatment Emergent Adverse Events (TEAEs)","type":"SECONDARY","unitOfMeasure":"Participants"}