{"analyses":[{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"< 0.0001","pValueComment":"The null hypothesis is ≤ 20%.","statisticalMethod":"Exact binomial test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"48.4","upperLimit":"66.4","value":"57.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"125"}],"units":"Participants"}],"description":"Overall response rate (ORR) was assessed based on the International Working Group Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), and was defined as the percentage of participants achieving a complete response (CR) or partial response (PR; or minor response \\[MR\\] for participants with WM) as assessed by the study independent review committee (IRC).\n\nCR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.\n\nPR was defined as a ≥ 50% reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions.\n\nFor WM only, response was defined as a reduction in immunoglobulin M (IgM) of ≥ 50% decrease for PR, and ≥ 25% decrease for MR; no increase from baseline in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions or signs and symptoms of active disease (Owen, 2013)","dispersionType":"95% Confidence Interval","groups":[{"description":"Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.","id":"OG000","title":"Idelalisib"}],"paramType":"NUMBER","populationDescription":"ITT Analysis Set included enrolled participants who received at least one dose of study drug.","reportingStatus":"POSTED","timeFrame":"Start of Treatment to End of Treatment (up to 81 months)","title":"Overall Response Rate","type":"PRIMARY","unitOfMeasure":"percentage of participants"}