{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"22"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"5"}]}],"title":"≥ 1 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"4"}]}],"title":"≥ 1 TEAE Related to (R/T) Oral Azacitidine (AZA)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"4"}]}],"title":"≥ 1 TEAE R/T Durvalumab (Durva)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"4"}]}],"title":"≥ 1 TEAE R/T Oral AZA or Durva"},{"categories":[{"measurements":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"5"}]}],"title":"≥ 1 Serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"1"}]}],"title":"≥ 1 Serious TEAE R/T Oral AZA"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"}]}],"title":"≥ 1 Serious TEAE R/T Durva"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"1"}]}],"title":"≥ 1 Serious TEAE R/T Oral AZA or Durva"},{"categories":[{"measurements":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"19"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"5"}]}],"title":"≥ 1 NCI CTC Grade (GR) 3 or 4 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"3"}]}],"title":"≥ 1 NCI CTC GR 3 or 4 TEAE R/T Oral AZA"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"2"}]}],"title":"≥ 1 NCI CTC GR 3 or 4 TEAE R/T Durva"},{"categories":[{"measurements":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"3"}]}],"title":"≥ 1 NCI CTC GR 3 or 4 TEAE R/T AZA or Durva"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"0"}]}],"title":"≥ 1 TEAE Leading to Death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"≥ 1 TEAE Leading to Death R/T Oral AZA"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"≥ 1 TEAE Leading to Death R/T Durva"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"≥ 1 TEAE Leading to Death R/T AZA or Durva"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]}],"title":"≥ 1 TEAE Leading to Dose Reduction of AZA"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"≥ 1 TEAE Leading to Reduction of Durva"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]}],"title":"≥ 1 TEAE Leading to Reduction of AZA or Durva"},{"categories":[{"measurements":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"4"}]}],"title":"≥1 TEAE Leading to Interruption of AZA"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"0"}]}],"title":"≥1 TEAE Leading to Interruption of Durva"},{"categories":[{"measurements":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"4"}]}],"title":"≥1 TEAE Leading to Interruption of AZA or Durva"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"4"}]}],"title":"≥ 1 TEAE Leading to Discontinuation (D/C) of AZA"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"}]}],"title":"≥ 1 TEAE Leading to D/C of Durva"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"4"}]}],"title":"≥ 1 TEAE Leading to D/C of AZA or Durva"}],"denoms":[{"counts":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"22"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"5"}],"units":"Participants"}],"description":"TEAEs were defined as AEs occurring or worsening on or after the date of the first dose of oral aza or durva and within 28 days after last dose of oral aza or 90 days after last dose of durva A serious adverse event (SAE) is any: • Death; • Life-threatening event; • Any inpatient hospitalization or prolongation of existing hospitalization; • Persistent or significant disability or incapacity; • Congenital anomaly or birth defect; • Any other important medical event The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 4.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death.","groups":[{"description":"Participants were given oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.","id":"OG000","title":"Stable Disease (SD) Cohort: Oral Azacitidine"},{"description":"Participants were given oral azacitidine 100 mg, 150mg, or 200mg tablets BID on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.","id":"OG001","title":"Progressive Disease (PD) Cohort: Oral Azacitidine"},{"description":"Participants received 100 mg oral azacitidine (AZA) tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab (Durva) 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.","id":"OG002","title":"Stable Disease Cohort: Oral Azacitidine and Durvalumab"},{"description":"Participants received 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.","id":"OG003","title":"Progressive Disease Cohort: Oral Azacitidine and Durvalumab"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The safety population included all enrolled participants who received at least 1 dose of IP and had at least 1 post-dose safety assessment.","reportingStatus":"POSTED","timeFrame":"From first dose until 28 days after the last dose of CC-486 (90 days after the last dose of durvalumab) or the last follow up visit, whichever date is later (Up to 91 months)","title":"Number of Participants With Treatment Emergent Adverse Events (TEAEs)","type":"SECONDARY","unitOfMeasure":"Participants"}