{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"147"},{"groupId":"OG001","value":"306"}]}],"title":"PA DCO: All TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"113"},{"groupId":"OG001","value":"253"}]}],"title":"PA DCO: TEAEs: Severity Grade >=3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"70"},{"groupId":"OG001","value":"173"}]}],"title":"PA DCO: TEAEs: Serious Adverse Events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"65"}]}],"title":"PA DCO: TEAEs: Leading to discon of carfilzomib"},{"categories":[{"measurements":[{"comment":"not relevant for this treatment arm","groupId":"OG000","value":"NA"},{"groupId":"OG001","value":"28"}]}],"title":"PA DCO: TEAEs: Leading to discon of daratumumab"},{"categories":[{"measurements":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"33"}]}],"title":"PA DCO: TEAEs: Leading to discon of dexamethasone"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"30"}]}],"title":"PA DCO: Fatal TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"129"},{"groupId":"OG001","value":"260"}]}],"title":"PA DCO: Treatment-related TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"187"}]}],"title":"PA DCO: Related TEAEs: Grade >=3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"84"}]}],"title":"PA DCO: Related and serious TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"50"}]}],"title":"PA DCO: Related TEAEs: discon of carfilzomib"},{"categories":[{"measurements":[{"comment":"not relevant for this treatment arm","groupId":"OG000","value":"NA"},{"groupId":"OG001","value":"15"}]}],"title":"PA DCO: Related TEAEs: discon of daratumumab"},{"categories":[{"measurements":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"19"}]}],"title":"PA DCO: Related TEAEs: discon of dexamethasone"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"5"}]}],"title":"PA DCO: Related Fatal TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"149"},{"groupId":"OG001","value":"306"}]}],"title":"FA DCO: All TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"273"}]}],"title":"FA DCO: TEAEs: Severity Grade >=3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"211"}]}],"title":"FA DCO: TEAEs: Serious Adverse Events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"98"}]}],"title":"FA DCO: TEAEs: Leading to discontinuation of carfilzomib"},{"categories":[{"measurements":[{"comment":"not relevant for this treatment arm","groupId":"OG000","value":"NA"},{"groupId":"OG001","value":"43"}]}],"title":"FA DCO: TEAEs: Leading to discontinuation of daratumumab"},{"categories":[{"measurements":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"58"}]}],"title":"FA DCO: TEAEs: Leading to discon of dexamethasone"},{"categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"39"}]}],"title":"FA DCO: Fatal TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"131"},{"groupId":"OG001","value":"267"}]}],"title":"FA DCO: Treatment-related TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"82"},{"groupId":"OG001","value":"206"}]}],"title":"FA DCO: Related TEAEs: Grade >=3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"102"}]}],"title":"FA DCO: Related and serious TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"69"}]}],"title":"FA DCO: Related TEAEs: discon of carfilzomib"},{"categories":[{"measurements":[{"comment":"not relevant for this treatment arm","groupId":"OG000","value":"NA"},{"groupId":"OG001","value":"18"}]}],"title":"FA DCO: Related TEAEs: discon of daratumumab"},{"categories":[{"measurements":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"30"}]}],"title":"FA DCO: Related TEAEs: discon of dexamethasone"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"5"}]}],"title":"FA DCO: Related Fatal TEAEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"153"},{"groupId":"OG001","value":"308"}],"units":"Participants"}],"description":"Treatment-emergent adverse events are defined as any adverse event with an onset after the administration of the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurs earlier.\n\nThe severity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening; Grade 5 = Fatal.\n\nTreatment-related adverse events are treatment-emergent adverse events considered related to at least one study drug by the investigator, including those with unknown relationship.","groups":[{"description":"Carfilzomib was administered intravenously (IV) at 20 mg/m\\^2 in Cycle 1: days 1 and 2; at 56 mg/m\\^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m\\^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16.\n\nDexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles.","id":"OG000","title":"Kd - Carfilzomib and Dexamethasone"},{"description":"Carfilzomib was administered intravenously (IV) at 20 mg/m\\^2 in Cycle 1: days 1 and 2; at 56 mg/m\\^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m\\^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16.\n\nDexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles. The administration of dexamethasone was given on carfilzomib and/or daratumumab IV infusion days.\n\nDaratumumab was administered by IV at 8 mg/kg on Cycle 1: days 1 and 2; at 16 mg/kg on Cycle 1: days 8, 15 and 22, and Cycle 2: days 1, 8, 15, and 22. The 16 mg/kg dosage was continued on Cycles 3-6: days 1 and 15. The 16 mg/kg dosage was continued on Cycles 7+: day 1 only.","id":"OG001","title":"KdD - Carfilzomib, Dexamethasone and Daratumumab"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety Population","reportingStatus":"POSTED","timeFrame":"PA DCO: the longest treatment duration as of the PA DCO was 102.3 weeks; FA DCO: the longest treatment duration as of the FA DCO was 236.3 weeks","title":"Number of Participants With Treatment-Emergent Adverse Events (TEAEs)","type":"SECONDARY","unitOfMeasure":"Participants"}