{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"description":"An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. The severity grade was evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL), Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5 was: death related to AE.","groups":[{"description":"Participants received ixazomib capsule, orally, at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 7 years whichever was sooner.","id":"OG000","title":"Ixazomib Monotherapy"},{"description":"Participants received combination therapy with ixazomib capsule, orally and another medication(s) (1 or more of the anticancer agents dexamethasone, lenalidomide or cyclophosphamide) at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, met other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 6.5 years whichever was sooner.","id":"OG001","title":"Ixazomib Combination Therapy"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety Population included all enrolled participants who received at least 1 dose of ixazomib.","reportingStatus":"POSTED","timeFrame":"Up to 7 years","title":"Number of Participants With ≥ Grade 3 AEs","type":"PRIMARY","unitOfMeasure":"Participants"}