{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"18"}]}],"title":">= 1 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"17"}]}],"title":">=1 treatment-related TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"15"}]}],"title":">=1 related to DURVA"},{"categories":[{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"15"}]}],"title":">=1 related to LEN"},{"categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"6"},{"comment":"Dexamethasone not administered to Cohort C","groupId":"OG002","value":"NA"}]}],"title":">=1 related to dex"},{"categories":[{"measurements":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"7"}]}],"title":">=1 TEAE of severity grade 3 or 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"6"}]}],"title":">=1 severity 3/4, related to study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"4"}]}],"title":">=1 severity 3/4, related to DURVA"},{"categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"4"}]}],"title":">=1 severity 3/4, related to LEN"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"2"},{"comment":"Dexamethasone not administered to Cohort C","groupId":"OG002","value":"NA"}]}],"title":">=1 severity 3/4, related to dex"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":">=1 Grade 5 TEAE (Death)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":">=1 Grade 5 TEAE related to study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":">=1 Grade 5 TEAE related to DURVA"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":">=1 Grade 5 TEAE related to LEN"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"comment":"Dexamethasone not administered to Cohort C","groupId":"OG002","value":"NA"}]}],"title":">=1 Grade 5 TEAE related to dex"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"4"}]}],"title":">=1 Serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"4"}]}],"title":">=1 Serious TEAE related to study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"4"}]}],"title":">=1 Serious TEAE related to DURVA"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"2"}]}],"title":">=1 Serious TEAE related to LEN"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"1"},{"comment":"Dexamethasone not administered to Cohort C","groupId":"OG002","value":"NA"}]}],"title":">=1 Serious TEAE related to dex"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":">=1 TEAE leading to discontinuation of study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":">= TEAE leading to discontinuation of DURVA"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":">= TEAE leading to discontinuation of LEN"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"comment":"Dexamethasone not administered to Cohort C","groupId":"OG002","value":"NA"}]}],"title":">= TEAE leading to discontinuation of dex"},{"categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"6"}]}],"title":">=1 leading to delay/reduction/interruption drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"4"}]}],"title":">=1 leading to dose delay of DURVA"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":">=1 leading to infusion interruption of DURVA"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"3"}]}],"title":">=1 leading to dose reduction of LEN"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"}]}],"title":">=1 leading to interruption of LEN"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"3"},{"comment":"Dexamethasone not administered to Cohort C","groupId":"OG002","value":"NA"}]}],"title":">=1 leading to dose reduction of dex"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"3"},{"comment":"Dexamethasone not administered to Cohort C","groupId":"OG002","value":"NA"}]}],"title":">=1 leading to interruption of dex"}],"denoms":[{"counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"21"}],"units":"Participants"}],"description":"An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. A TEAE includes AEs between the first dose date of either study drug and 90 days after the last dose of study drug. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.03): - Grade 1 = Mild - Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required) - Grade 3 = Severe (limitation in activity; medical intervention required) - Grade 4 = Life-threatening - Grade 5 = Death","groups":[{"description":"High risk, transplant non-eligible \\[TNE\\], newly diagnosed multiple myeloma (NDMM) participants who were administered • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance \\[CrCl\\] value) on Days 1 to 21 of each 28-day treatment cycle • Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (\\> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle.","id":"OG000","title":"Cohort A: High Risk, TNE"},{"description":"\\>= 65 years old, transplant non-eligible \\[TNE\\], newly diagnosed multiple myeloma (NDMM) participants who were not high risk were administered • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance \\[CrCl\\] value) on Days 1 to 21 of each 28-day treatment cycle • Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (\\> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle, up to 12 cycles.","id":"OG001","title":"Cohort B: >=65 Years Old, TNE"},{"description":"High risk, post-transplant NDMM participants were administered the following as maintenance therapy: • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 10 mg/day on Days 1 to 21 of each 28-day treatment cycle.","id":"OG002","title":"Cohort C: High Risk, Post-transplant"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety population. The Safety Population is defined as all enrolled subjects who receive at least 1 dose of the study medications.","reportingStatus":"POSTED","timeFrame":"Day 1 up to Week 84 (the longer of 90 days after discontinuing treatment with DURVA, or 28 days after the last dose of LEN or dex)","title":"Participants With Treatment Emergent Adverse Events (TEAE)","type":"SECONDARY","unitOfMeasure":"Participants"}