{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"title":"Any dose-limiting toxicity"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"title":"Gastric hemorrhage"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"title":"Abdominal distension"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"title":"Cognitive disorder"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"title":"Mucosal inflammation"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"10"},{"groupId":"OG004","value":"10"}],"units":"Participants"}],"description":"DLTs were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03, defined as any of the following treatment-related events occurring within 4 weeks after the first dose of therapy:\n\nAny grade ≥ 3 nonhematologic toxicity, except: Grade 3 asymptomatic electrolyte abnormalities or hypophosphatemia for \\< 24 hours; Grade 3 nausea, vomiting or diarrhea unless for \\> 3 days despite optimal supportive care; Grade 3 fatigue for \\< 14 days; Grade ≥ 3 hyperglycemia or toxicity attributed to dexamethasone and Grade ≥ 3 rash attributed to pomalidomide.\n\nHematologic toxicities:\n\n* Grade 4 neutropenia: Absolute neutrophil count \\< 0.5 × 10\\^9/L for ≥ 7 days despite adequate growth factor support; febrile neutropenia\n* Thrombocytopenia: Grade 4 for ≥ 7 days, or Grade 4 for \\< 7 days with grade 2 clinically significant bleeding or \\< 10,000 platelets requiring 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 pomalidomide 4 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.","id":"OG000","title":"Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone"},{"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 pomalidomide 2 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.","id":"OG001","title":"Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + 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 pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.","id":"OG002","title":"Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + 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 pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.","id":"OG003","title":"Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + 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 pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.","id":"OG004","title":"Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Participants who received at least 1 dose of any study drug","reportingStatus":"POSTED","timeFrame":"Cycle 1, 28 days","title":"Number of Participants With Dose-limiting Toxicities (DLTs)","type":"PRIMARY","unitOfMeasure":"Participants"}