{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.010","upperLimit":"0.165","value":"0.056"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"36"}],"units":"Participants"}],"description":"Proportion of patients with grade 3 adverse events that effect vital organ function (such as cardiac, hepatic or thromboembolic) or any grade 4 or higher non-hematologic adverse events","dispersionType":"90% Confidence Interval","groups":[{"description":"Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Arm A (Lenalidomide; Phase II)"}],"paramType":"NUMBER","populationDescription":"The first 36 patients in the phase II part as planned in the study design","reportingStatus":"POSTED","timeFrame":"Assessed every 4 weeks while on treatment up to 24 weeks","title":"Proportion of Patients With Grade 3 Adverse Events That Effect Vital Organ Function or Any Grade 4 or Higher Non-hematologic Adverse Events (Phase II Primary Endpoint)","type":"PRIMARY","unitOfMeasure":"proportion of participants"}