{"analyses":[{"groupDescription":"Comparison to a fixed efficacy target of 10%. H0: p ≤ 0.10 versus H1: p \\> 0.10","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":">0.9999","pValueComment":"one-sided p value","statisticalMethod":"exact binomial distribution"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.0","upperLimit":"10.5","value":"0.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"27"}],"units":"Participants"}],"description":"ORR was defined as the percentage of participants with response (complete response \\[CR\\] or partial response \\[PR\\]) according to the International Working Group (IWG) response criteria in myelodysplasia per Cheson et al. 2006. CR was demonstrated by ≤5% myeloblasts with normal maturation of all cell lines in the bone marrow (persistent dysplasia will be noted) and normal findings for hemoglobin, platelet count, neutrophil count, and absence of blasts in the blood. PR was all CR criteria if abnormal before treatment except bone marrow blasts decreased by ≥50% over pre-treatment but still \\>5%. Cellularity and morphology are not relevant. Cohort 1 was evaluated statistically by comparing the ORR for pembrolizumab to a fixed efficacy target of 10% using a binomial exact test. The percentage of participants with CR and PR as assessed by the investigator is presented.","dispersionType":"90% Confidence Interval","groups":[{"description":"Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.","id":"OG000","title":"Cohort 1: Myelodysplastic Syndrome (MDS)"}],"paramType":"NUMBER","populationDescription":"All participants in Cohort 1 with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.","reportingStatus":"POSTED","timeFrame":"Up to approximately 78.5 months","title":"Objective Response Rate (ORR) in Cohort 1: Myelodysplastic Syndrome (MDS)","type":"PRIMARY","unitOfMeasure":"Percentage of participants"}