{"analyses":[{"ciLowerLimit":"1.06","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.03","estimateComment":"The strata information was based on the data obtained from the interactive response technology that was used for randomization.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.","nonInferiorityType":"SUPERIORITY","pValue":"0.0221","paramType":"Odds Ratio (OR)","paramValue":"1.5","statisticalMethod":"stratified Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"44.78","upperLimit":"56.58","value":"50.7"},{"groupId":"OG001","lowerLimit":"35.60","upperLimit":"47.17","value":"41.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"290"},{"groupId":"OG001","value":"293"}],"units":"Participants"}],"description":"CR was defined as a complete metabolic response at any time after the start of treatment. Per PET, CR criteria: (1) score of 1, 2, or 3 with or without a residual mass on a 5-point scale for lymph nodes and extralymphatic sites; (2) No evidence of FDG-avid disease in bone marrow; and (3) no new lesions. PET 5-point scale: 1 = no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake \\> mediastinum but ≤ liver; 4 = uptake moderately \\> liver; 5 = uptake markedly higher than liver and/or new lesions; X = new areas of uptake unlikely to be related to lymphoma. The Overall FDG-avid Set included all randomized participants with a PET scan at Baseline with a resulting Deauville score of 4 or 5.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants with FL and MZL were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.","id":"OG000","title":"FL and MZL: Tafasitamab + Rituximab + Lenalidomide"},{"description":"Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.","id":"OG001","title":"FL and MZL: Placebo + Rituximab + Lenalidomide"}],"paramType":"NUMBER","populationDescription":"Overall FDG-avid Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Participants who did not have a post-baseline PET scan were considered to be \"not assessed,\" but were included in the analysis. The 95% confidence intervals were calculated using the Clopper-Pearson method.","reportingStatus":"POSTED","timeFrame":"up to approximately 34 months","title":"FDG-avid Overall Population: PET-CR Rate by Investigator Assessment, Using the Lugano 2014 Criteria","type":"SECONDARY","unitOfMeasure":"percentage of participants"}