{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.8","upperLimit":"20.8","value":"6.3"},{"groupId":"OG001","lowerLimit":"0.1","upperLimit":"22.8","value":"4.5"},{"groupId":"OG002","lowerLimit":"0.4","upperLimit":"64.1","value":"16.7"},{"comment":"Could not be estimated as there were 0 responders.","groupId":"OG003","lowerLimit":"NA","upperLimit":"NA","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"22"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"5"}],"units":"Participants"}],"description":"The overall response rate (ORR) was defined as the percentage of participants who achieved an objective response including: hematologic improvement (HI), partial remission (PR), complete remission (CR), or marrow complete remission (mCR). Hematologic response was defined as: • CR: ≤ 5% myeloblasts with normal maturation of all cell lines; peripheral blood (PB) shows: hemoglobin ≥11 g/dL, neutrophils ≥1.0x10\\^9/L, platelets ≥100x10\\^9/dL, blasts (0%) • PR: same as CR bone marrow (BM) shows blasts decreased by ≥ 50% over pre-treatment but still \\> 5%; cellularity and morphology not relevant • mCR: BM: ≤ 5% myeloblasts and decrease by ≥ 50% over pre-treatment PB, PB: if HI responses, noted in addition to mCR • HI: HI erythroid response (HI-E); HI neutrophil response (HI-N) ; HI platelet response (HI-P)","dispersionType":"95% Confidence Interval","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":"NUMBER","populationDescription":"The intent-to-treat (ITT) population included all enrolled participants who received at least one dose of investigational product (IP).","reportingStatus":"POSTED","timeFrame":"Response was assessed every 2 cycles following treatment during the first 6 cycles, then every 3 cycles thereafter; median duration of treatment = 5.26 and 3.81 months for SD/PD for oral AZA arms respectively, and 1.84 months for AZA and Durva SD/PD arms","title":"Overall Response Rate Based on the Modified International Working Group (IWG) 2006 Response Criteria for Myelodysplastic Syndrome (MDS)","type":"PRIMARY","unitOfMeasure":"Percentage of Participants"}