{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"1"},{"groupId":"OG008","value":"1"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"4"},{"groupId":"OG006","value":"3"},{"groupId":"OG007","value":"8"},{"groupId":"OG008","value":"6"},{"groupId":"OG009","value":"7"},{"groupId":"OG010","value":"4"}],"units":"Participants"}],"description":"A DLT was defined as any of the following occurring in the first 28 days of study participation:\n\nNonhematologic:\n\n* \\> Grade 2 neuropathy with pain\n* ≥ Grade 3 nonhematologic toxicity (excluding nausea, vomiting, or diarrhea)\n* ≥ Grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal therapy\n\nHematologic:\n\n* Grade 4 neutropenia (absolute neutrophil count \\[ANC\\] \\< 0.5 × 10ˆ9/L) lasting ≥ 14 days without hematopoietic growth factor support\n* Febrile neutropenia (ANC \\< 1.0 × 10ˆ9/L with a fever ≥ 38.3°C)\n* Grade 4 thrombocytopenia (platelets \\< 25.0 × 10ˆ9/L) or thrombocytopenia associated with bleeding.\n\nToxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) version 3.0.","groups":[{"description":"Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.","id":"OG000","title":"CFZ 1.2 mg/m²"},{"description":"Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.","id":"OG001","title":"CFZ 2.4 mg/m²"},{"description":"Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.","id":"OG002","title":"CFZ 4.0 mg/m²"},{"description":"Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.","id":"OG003","title":"CFZ 6.0 mg/m²"},{"description":"Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.","id":"OG004","title":"CFZ 8.4 mg/m²"},{"description":"Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.","id":"OG005","title":"CFZ 11.0 mg/m²"},{"description":"Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.","id":"OG006","title":"CFZ 15.0 mg/m²"},{"description":"Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.","id":"OG007","title":"CFZ 20.0 mg/m²"},{"description":"Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.","id":"OG008","title":"CFZ 27.0 mg/m²"},{"description":"Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.","id":"OG009","title":"CFZ 20/27 mg/m²"},{"description":"Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).","id":"OG010","title":"CFZ 20/27 mg/m² + DEX"}],"paramType":"NUMBER","populationDescription":"Safety-evaluable: All participants who were enrolled and received at least 1 dose of carfilzomib","reportingStatus":"POSTED","timeFrame":"28 days","title":"Number of Participants With Dose-limiting Toxicities (DLTs)","type":"PRIMARY","unitOfMeasure":"participants"}