{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"3"}]}],"title":"With one or more laboratory AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"3"}]}],"title":"With no laboratory AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"3"}]}],"title":"With drug-related laboratory AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}],"title":"With laboratory Serious AEs (SAEs)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}],"title":"With drug-related laboratory SAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}],"title":"Who died"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}],"title":"Who discontinued due to laboratory AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}],"title":"Who discontinued due to drug-related lab AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}],"title":"Who discontinued due to laboratory SAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}],"title":"Who discontinued due to drug-related lab SAEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"6"},{"groupId":"OG005","value":"6"}],"units":"Participants"}],"description":"An AE was defined as any unfavorable/unintended change in the structure/function/chemistry of the body temporally associated with the use of study drug, or any worsening of a preexisting condition.\n\nA SAE was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a new cancer, or was an overdose.\n\nA lab (S)AE was any lab value considered clinically significant in the investigator's judgment.","groups":[{"description":"Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).\n\nBortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle).","id":"OG000","title":"Vorinostat 200 mg + Bortezomib 0.7 mg/m^2"},{"description":"Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).\n\nBortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle).","id":"OG001","title":"Vorinostat 200 mg + Bortezomib 0.9 mg/m^2"},{"description":"Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).\n\nBortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).","id":"OG002","title":"Vorinostat 300 mg + Bortezomib 1.3 mg/m^2"},{"description":"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).\n\nBortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).","id":"OG003","title":"Vorinostat 400 mg + Bortezomib 0.9 mg/m^2"},{"description":"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).\n\nBortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).","id":"OG004","title":"Vorinostat 400 mg + Bortezomib 1.1 mg/m^2"},{"description":"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).\n\nBortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).","id":"OG005","title":"Vorinostat 400 mg + Bortezomib 1.3 mg/m^2"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"Day 1 up to disease progression, toxicity, or death, assessed up to 29 months","title":"Laboratory AE Summary","type":"SECONDARY","unitOfMeasure":"Participants"}