{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"35"}],"units":"Participants"}],"description":"Clinical laboratory assessments included hematology, serum chemistry, and urinalysis. Any clinically significant changes in the clinical laboratory value over time based on the investigator's interpretation were reported.","groups":[{"description":"Participants received ixazomib 3 mg, capsules, orally, once on Days 1, 8, and 15 for Cycles 1 through 4, during which if the participants tolerated the initial dose, the dose was escalated to ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 for Cycles 5 through 26, or until documented progressive disease (PD) or intolerable toxicity, whichever occurred first (cycle length=28 days).","id":"OG000","title":"Ixazomib"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"ISP included all participants who received at least 1 dose of ixazomib. As prespecified in the SAP, the ISP contained only one arm i.e., Ixazomib (participants originally randomized to ixazomib + participants who were randomized to the placebo arm prior to implementation of Amendment 08 and who crossed over to ixazomib arm contributing data for this outcome measure from the time they initiated ixazomib onward), thus data is presented accordingly.","reportingStatus":"POSTED","timeFrame":"Up to 58.4 months","title":"Number of Participants Receiving Ixazomib With Clinically Significant Changes in Safety Laboratory Values","type":"PRIMARY","unitOfMeasure":"Participants"}