{"description":"Safety population included all participants who received at least 1 dose of any drug. 4 participants who were randomized to the placebo received ixazomib during the study and were included in the ixazomib arm for the safety population. 1 participant randomized to each arm withdrew from the study and were not included in the safety population. Data for safety is summarized as per the duration of exposure to study treatment (exposure up to 18 cycles; exposure ≥19 cycles).","eventGroups":[{"deathsNumAffected":107,"deathsNumAtRisk":160,"description":"Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days).","id":"EG000","otherNumAffected":159,"otherNumAtRisk":160,"seriousNumAffected":105,"seriousNumAtRisk":160,"title":"Placebo + LenDex (Exposure Up to 18 Cycles)"},{"deathsNumAffected":95,"deathsNumAtRisk":163,"description":"Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days).","id":"EG001","otherNumAffected":162,"otherNumAtRisk":163,"seriousNumAffected":119,"seriousNumAtRisk":163,"title":"Ixazomib+ LenDex (Exposure Up to 18 Cycles)"},{"deathsNumAffected":63,"deathsNumAtRisk":189,"description":"Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib placebo matching capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).","id":"EG002","otherNumAffected":189,"otherNumAtRisk":189,"seriousNumAffected":119,"seriousNumAtRisk":189,"title":"Placebo + LenDex (Exposure ≥19 Cycles)"},{"deathsNumAffected":63,"deathsNumAtRisk":191,"description":"Participants who were randomly assigned to receive Ixazomib 4.0 mg placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).","id":"EG003","otherNumAffected":191,"otherNumAtRisk":191,"seriousNumAffected":125,"seriousNumAtRisk":191,"title":"Ixazomib + LenDex (Exposure ≥19 Cycles)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA: 22.0","stats":[{"groupId":"EG000","numAffected":52,"numAtRisk":160},{"groupId":"EG001","numAffected":66,"numAtRisk":163},{"groupId":"EG002","numAffected":64,"numAtRisk":189},{"groupId":"EG003","numAffected":106,"numAtRisk":191}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA: 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