{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"49"}]}],"title":"Any TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"37"}]}],"title":"Any TEAE Related to Study Drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"27"}]}],"title":"Any Serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"6"}]}],"title":"Any Serious TEAE Related to Study Drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"27"}]}],"title":"Any CTC Grade 3/4 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"10"}]}],"title":"Any CTC Grade 3/4 TEAE Related to Study Drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"9"}]}],"title":"Any TEAE Leading to Death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"1"}]}],"title":"Any TEAE Leading to Dose Reduction"},{"categories":[{"measurements":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"20"}]}],"title":"Any TEAE Leading to Dose Interruption"},{"categories":[{"measurements":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"8"}]}],"title":"Any TEAE Leading to Drug Discontinuation"}],"denoms":[{"counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"49"}],"units":"Participants"}],"description":"Treatment-emergent adverse events (TEAEs) were defined as any adverse event (AE) or serious adverse event (SAE) that occurred or worsened on or after the day of the first dose of the investigational product (IP) through 28 days after the last dose of IP. In addition, any SAE with an onset date more than 28 day after the last dose of IP that was assessed by the investigator as related to IP was considered a TEAE. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and based on the following scale: Grade 1 = Mild; Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death.","groups":[{"description":"Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.","id":"OG000","title":"CC-486 and Pembrolizumab (CC-486 + PBZ)"},{"description":"Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.","id":"OG001","title":"Placebo and Pembrolizumab (PBO + PBZ)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The safety population includes all participants who were randomized and received at least one dose of study drug.","reportingStatus":"POSTED","timeFrame":"From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the PBZ + Placebo arm","title":"Number of Participants With Treatment Emergent Adverse Events","type":"SECONDARY","unitOfMeasure":"Participants"}