{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"3"}],"units":"Participants"}],"description":"DLTs were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. A DLT is defined as any of the following treatment-related events:\n\n* Any ≥ Grade 3 nonhematologic toxicity with the following conditions:\n\n  * ≥ Grade 3 nausea, vomiting, diarrhea, or constipation only if for \\> 7 days despite optimal supportive care\n  * Asymptomatic Grade 3 hypophosphatemia, Grade 3 hyperglycemia or toxicity solely due to dexamethasone, ≥ Grade 3 rash attributed to lenalidomide, and Grade 3 fatigue for \\< 14 days were not considered DLTs\n* Grade 4 neutropenia: absolute neutrophil count (ANC) \\< 0.5 × 10\\^9/L lasting ≥ 7 days, despite myeloid growth factor support\n* Febrile neutropenia\n* Grade 4 thrombocytopenia for ≥ 7 days or \\< 7 days with ≥ Grade 2 clinically significant bleeding or \\< 10,000 platelets requiring platelet transfusion, or Grade ≥ 3 with clinically significant bleeding or requiring platelet transfusion.","groups":[{"description":"Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.\n\nAfter completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment.","id":"OG000","title":"Oprozomib 150 mg 5/14 + Lenalidomide + Dexamethasone"},{"description":"Participants received oprozomib 180 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.\n\nAfter completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment.","id":"OG001","title":"Oprozomib 180 mg 5/14 + Lenalidomide + Dexamethasone"},{"description":"Participants received oprozomib 210 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.\n\nAfter completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment.","id":"OG002","title":"Oprozomib 210 mg 5/14 + Lenalidomide + Dexamethasone"},{"description":"Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.\n\nAfter completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment.","id":"OG003","title":"Oprozomib 210 mg 2/7 + Lenalidomide + Dexamethasone"},{"description":"Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with lenalidomide 25 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 24 cycles, whichever occurred first.\n\nAfter completing 24 cycles of treatment, participants with stable disease or better could have continued on oprozomib with or without dexamethasone pretreatment.","id":"OG004","title":"Oprozomib 240 mg 2/7 + Lenalidomide + Dexamethasone"},{"description":"Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with oral cyclophosphamide 300 mg/m² on days 1, 8, and 15 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23, until progression of disease, unacceptable toxicity, or for 8 cycles, whichever occurred first.\n\nAfter completing 8 cycles of treatment, participants with stable disease or better were to continue on oprozomib with dexamethasone premedication for a total of 24 cycles or until progression of disease or unacceptable toxicity. After completing 24 cycles of treatment, participants without evidence of disease progression could have continued on oprozomib with or without dexamethasone pretreatment.","id":"OG005","title":"Oprozomib 210 mg 2/7 + Cyclophosphamide + Dexamethasone"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All enrolled participants who received at least 1 dose of any study treatment","reportingStatus":"POSTED","timeFrame":"Cycle 1, 28 days","title":"Number of Participants With Dose-Limiting Toxicities (DLTs)","type":"PRIMARY","unitOfMeasure":"Participants"}