{"analyses":[{"ciNumSides":"TWO_SIDED","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"A one sample binomial one sided exact test for the ORR (CR, CRu, or PR) was performed to provide the p-value (significance level: 0.05). The hypotheses of interest:\n\nH0: ORR ≤ 5% versus H1: ORR \\> 5%","statisticalMethod":"Exact Test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"23.352","upperLimit":"63.082","value":"42.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"26"}],"units":"Participants"}],"description":"ORR is a Complete Response (CR) + Complete Response unconfirmed (CRu) + Partial Response (PR). A CR requires that target lesions have regressed to normal; nodal non-target lesions have regressed to normal; extranodal non-target lesions have disappeared; hepatomegaly/splenomegaly has disappeared; skin findings are GR 0; peripheral blood is normal; Bone marrow (BM) infiltration is negative and no new lesions. A CRu requires the sum of the product diameters (SPD) of target lesions have decreased by at least 75% from baseline; nodal non-target lesions have regressed to normal size; extranodal non-target lesions have disappeared; hepatomegaly/splenomegaly has disappeared; skin findings are Grade 0; peripheral blood is normal; BM infiltration is \"negative\" and no new lesions. A PR requires the SPD of target lesions has decreased by at least 50% from baseline; all nodal non-target lesions have regressed to normal or show no increase in size; all extranodal non-target lesions have disappeared","dispersionType":"95% Confidence Interval","groups":[{"description":"Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity","id":"OG000","title":"Lenalidomide"}],"paramType":"NUMBER","populationDescription":"The Efficacy Evaluable (EE) population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide","reportingStatus":"POSTED","timeFrame":"From day 1 of study treatment to date of first documented CR, CRU or PR; Up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks","title":"Percentage of Participants Who Achieved a Complete Response, Unconfirmed Complete Response, or Partial Response as Assessed by the Efficacy-Safety Evaluation Committee (ESEC)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}