{"description":"Due to the high response rate of the bortezomib-dexmathasone (VD) in the first four cycles, not enough patients could be randomized to the sequential therapies in cycles 5-8 to allow us to evaluate safety data according randomization or intervention. Thus, adverse events were analyzed by combining (randomized) participants with SD After 4 Cycles.","eventGroups":[{"description":"Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8","id":"EG000","otherNumAffected":137,"otherNumAtRisk":144,"seriousNumAffected":59,"seriousNumAtRisk":144,"title":"Complete to Partial Response: Bortezomib + Dexamethasone"},{"description":"Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8","id":"EG001","otherNumAffected":19,"otherNumAtRisk":19,"seriousNumAffected":6,"seriousNumAtRisk":19,"title":"Stable Disease After 4 Cycles: VD, VDC, VDL"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (11.0)","stats":[{"groupId":"EG000","numAffected":52,"numAtRisk":144,"numEvents":216},{"groupId":"EG001","numAffected":8,"numAtRisk":19,"numEvents":22}],"term":"Thrombocytopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system 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