{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Hypertension"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Hypotension"}],"denoms":[{"counts":[{"groupId":"OG000","value":"34"}],"units":"Participants"}],"description":"Vital signs included temperature, blood pressure, heart rate, and respiratory rate. An AE is any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it was related to the medicinal product. A TEAE is defined as any AE that occurred after administration of the first dose of any study drug through 30 days after the last dose of any study drug. An AE was graded as per NCI CTCAE.","groups":[{"description":"Ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 plus lenalidomide 25 mg, capsule, orally, once daily on Days 1 through 21 and dexamethasone 40 mg, tablet, orally on Days 1, 8, 15, and 22 of a 28-day cycle up to 32 cycles.","id":"OG000","title":"Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety analysis set included all participants who received at least one dose of study drug during the treatment period.","reportingStatus":"POSTED","timeFrame":"Up to approximately 33 months","title":"Number of Participants With NCI CTCAE Grade 3 or Higher TEAEs Related to Vital Signs","type":"SECONDARY","unitOfMeasure":"Participants"}