{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"}],"units":"Participants"}],"description":"DLT:Any following adverse events (AEs) possibly related to ixazomib assessed by Common Terminology Criteria for AEs (CTCAE) version 4.03; Grade 4 neutropenia/thrombocytopenia lasting \\>7 consecutive days; Grade 3/greater neutropenia with fever/infections; Grade 3/greater thrombocytopenia with clinically significant bleeding; platelet count less than (\\<)10,000 per cubic meter(/mm\\^3); Grade 2 peripheral neuropathy with pain/Grade 3 or greater peripheral neuropathy; Grade 3/greater nonhematologic toxicities with exceptions of arthralgia/myalgia, fatigue lasting \\<7 days manageable nausea/emesis with antiemetic prophylaxis, diarrhea that is controlled with supportive care; treatment delay of \\>14 days at start of Cycle 2 due to failure of hematologic/nonhematologic recovery; Other Grade 2/greater ixazomib related nonhematologic toxicities required permanent discontinuation of ixazomib;Inability to receive at least 80% of planned lenalidomide doses due to the AEs related to ixazomib.","groups":[{"description":"Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle for up to Cycle 87.","id":"OG000","title":"Cohort 1: Ixazomib 4.0 mg"},{"description":"Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle along with lenalidomide 25 mg/day, capsules, orally, once, from Days 1 to 21 and dexamethasone 40 mg/day, tablets, orally, once, on Days 1, 8, 15, and 22 in a 28-day treatment cycle for up to Cycle 62.","id":"OG001","title":"Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The DLT analysis set consisted of DLT evaluable participants who received at least one dose of ixazomib.","reportingStatus":"POSTED","timeFrame":"From Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle length is equal to [=] 28 days)","title":"Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)","type":"PRIMARY","unitOfMeasure":"Participants"}