{"classes":[{"categories":[{"measurements":[{"comment":"Could not be estimated due to the low number of events","groupId":"OG000","lowerLimit":"2.0","upperLimit":"NA","value":"NA"},{"comment":"Could not be estimated due to the low number of events","groupId":"OG001","lowerLimit":"4.2","upperLimit":"NA","value":"NA"},{"groupId":"OG002","lowerLimit":"2.3","upperLimit":"27.4","value":"14.8"},{"comment":"Could not be estimated due to the low number of events","groupId":"OG003","lowerLimit":"7.9","upperLimit":"NA","value":"NA"},{"groupId":"OG004","lowerLimit":"6.5","upperLimit":"8.5","value":"7.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"3"}],"units":"Participants"}],"description":"Duration of Response is defined as the time from first evidence of PR or better to confirmation of disease progression or death.\n\nProgressive disease was defined as any of the following:\n\n* An increase of more than 25% from nadir in any one of the following:\n\n  * M-protein in serum (the absolute increase had to be ≥ 0.5 g/dL);\n  * Urine (the absolute increase had to be ≥ 200 mg/24 hours);\n  * The difference between involved and uninvolved sFLC (the absolute increase in the concentration of involved light chain had to be \\> 10 mg/dL);\n  * ≥ 10% bone marrow infiltration by plasma cells;\n* Increased size of pre-existing bone lesions or plasmacytomas or new bone lesions or plasmacytomas.\n\nMedian duration of response was estimated using the Kaplan-Meier method.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \\> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.\n\nIf the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.","id":"OG000","title":"Carfilzomib - Normal RF"},{"description":"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.\n\nIf the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.","id":"OG001","title":"Carfilzomib - Mild RI"},{"description":"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.\n\nIf the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.","id":"OG002","title":"Carfilzomib - Moderate RI"},{"description":"Participants with severe renal impairment (CrCL \\< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.\n\nIf the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.","id":"OG003","title":"Carfilzomib - Severe RI"},{"description":"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.\n\nIf the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.","id":"OG004","title":"Carfilzomib - Dialysis"}],"paramType":"MEDIAN","populationDescription":"Response Evaluable Population with a best overall response of sCR, CR, VGPR, or PR.","reportingStatus":"POSTED","timeFrame":"Participants were followed for disease progression for up to 2 years.","title":"Duration of Response","type":"SECONDARY","unitOfMeasure":"months"}