{"description":"Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":5,"description":"In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.","id":"EG000","otherNumAffected":4,"otherNumAtRisk":5,"seriousNumAffected":2,"seriousNumAtRisk":5,"title":"Oprozomib IR 150 mg/Day + Dexamethsone"},{"deathsNumAffected":0,"deathsNumAtRisk":8,"description":"In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.","id":"EG001","otherNumAffected":8,"otherNumAtRisk":8,"seriousNumAffected":2,"seriousNumAtRisk":8,"title":"Oprozomib GR 150 mg/Day + Dexamethasone"},{"deathsNumAffected":1,"deathsNumAtRisk":3,"description":"In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.","id":"EG002","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":2,"seriousNumAtRisk":4,"title":"Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone"},{"deathsNumAffected":0,"deathsNumAtRisk":5,"description":"In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.","id":"EG003","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":4,"seriousNumAtRisk":4,"title":"Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone"},{"deathsNumAffected":0,"deathsNumAtRisk":9,"description":"In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.","id":"EG004","otherNumAffected":8,"otherNumAtRisk":8,"seriousNumAffected":6,"seriousNumAtRisk":8,"title":"Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone"},{"deathsNumAffected":2,"deathsNumAtRisk":5,"description":"In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.","id":"EG005","otherNumAffected":5,"otherNumAtRisk":5,"seriousNumAffected":5,"seriousNumAtRisk":5,"title":"Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone"},{"deathsNumAffected":1,"deathsNumAtRisk":11,"description":"In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.","id":"EG006","otherNumAffected":10,"otherNumAtRisk":10,"seriousNumAffected":3,"seriousNumAtRisk":10,"title":"Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone"},{"deathsNumAffected":0,"deathsNumAtRisk":8,"description":"In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle","id":"EG007","otherNumAffected":8,"otherNumAtRisk":8,"seriousNumAffected":4,"seriousNumAtRisk":8,"title":"Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone"},{"deathsNumAffected":0,"deathsNumAtRisk":7,"description":"Eligible participants who had enrolled on separate Amgen oprozomib studies (2011-001 \\[NCT01416428\\], 2012-001 \\[NCT01832727\\], OPZ003 \\[NCT01881789\\], OPZ007 \\[NCT01999335\\], and OPZ009 \\[NCT02244112\\]) and were receiving oprozomib as monotherapy, or a combination of oprozomib with dexamethasone, continued treatment in research centers within the United States only. Participants continued receiving the previous dose/schedule of oprozomib GR formulation until disease progression, death, or unacceptable toxicity.","id":"EG008","otherNumAffected":7,"otherNumAtRisk":7,"seriousNumAffected":4,"seriousNumAtRisk":7,"title":"Open-label Roll-over"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5},{"groupId":"EG001","numAffected":2,"numAtRisk":8},{"groupId":"EG002","numAffected":3,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":4},{"groupId":"EG004","numAffected":2,"numAtRisk":8},{"groupId":"EG005","numAffected":2,"numAtRisk":5},{"groupId":"EG006","numAffected":3,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":8},{"groupId":"EG008","numAffected":2,"numAtRisk":7}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":5},{"groupId":"EG001","numAffected":0,"numAtRisk":8},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":4},{"groupId":"EG004","numAffected":0,"numAtRisk":8},{"groupId":"EG005","numAffected":0,"numAtRisk":5},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":8},{"groupId":"EG008","numAffected":0,"numAtRisk":7}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 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All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days."}