{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"18"}]}],"title":"TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"TEAE Related to Durva"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"TEAE Related to Dara"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"TEAE Related to Durva or Dara"},{"categories":[{"measurements":[{"groupId":"OG000","value":"11"}]}],"title":"TEAE with CTCAE Grade (Gr) 3-4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"TEAE with CTCAE Grade 3-4 Related to Durva"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"TEAE with CTCAE Grade 3-4 Related to Dara"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"TEAE with CTCAE Gr 3-4 Related to Durva or Dara"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"TEAE with CTCAE Grade 5"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"TEAE with CTCAE Grade 5 Related to Durva"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"TEAE with CTCAE Grade 5 Related to Dara"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"TEAE with CTCAE Gr 5 Related to Durva or Dara"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"}]}],"title":"Serious AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Serious AE Related to Durva"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Serious AE Related to Dara"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Serious AE Related to Durva or Dara"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"TEAE leading to Interruption of Durva"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"TEAE leading to Interruption of Dara"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"TEAE leading to Interruption of Durva or Dara"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"TEAE interruption of Durva-without infusion delay"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"TEAE interruption of Dara-without infusion delay"}],"denoms":[{"counts":[{"groupId":"OG000","value":"18"}],"units":"Participants"}],"description":"TEAEs include AEs between the earliest of the first dose date of either study drug and 90 days after the last dose of either study drug. In addition, an AE that occurred beyond the timeframe and was assessed by the doctor as possibly related to IP was considered to be treatment-emergent. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for AEs (NCI CTCAE) version 4.03, where 1= Mild; 2= Moderate; 3= Severe; 4= Life-threatening; 5= Death related to AE. Serious AEs resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in a medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes above.","groups":[{"description":"Participants received intravenous daratumumab at 16 mg/kg on the same dosing schedule (weekly, every 2 weeks, or every 4 weeks of each 28-day treatment cycle) on their last prior therapy containing daratumumab regimen. The dosing schedule for daratumumab could be adjusted during the course of the study, provided the participant had a response of stable disease or better. Participants also received IV durvalumab at 1500 mg on Day 2 of Cycle 1 and then on Day 1 of Cycles ≥ 2 of each 28-day treatment cycle. Participants could continue on study treatment until progressive disease or unacceptable toxicity.","id":"OG000","title":"Daratumumab and Durvalumab"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The safety population consisted of all participants who received at least one dose of Durvalumab (Durva) or Daratumumab (Dara).","reportingStatus":"POSTED","timeFrame":"From the date of the first dose of study drug until 90 days after the last dose of durvalumab or daratumumab , whichever is later. Maximum overall time on treatment was 16 weeks for daratumumab and durvalumab","title":"Participants With Treatment-Emergent Adverse Events (TEAEs)","type":"SECONDARY","unitOfMeasure":"Participants"}