{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0005","statisticalComment":"stratified 1-sided log-rank test","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.88","upperLimit":"0.99","value":"0.93"},{"groupId":"OG001","lowerLimit":"0.66","upperLimit":"0.87","value":"0.76"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"90"},{"groupId":"OG001","value":"92"}],"units":"Participants"}],"description":"PFS is defined as time from randomization to progression or death, whichever occurs first. Patients are considered to have progression if both of the following criteria are met. Kaplan-Meier method was used to estimate 2-year PFS rate.\n\n1. Any of the following:\n\n   * Increase in serum M-protein to ≥ 25% above the lowest response level with an absolute increase of at least 0.5g/dl to qualify as \"progression\"\n   * Increase in urine M-protein to ≥ 25% above the lowest response level for 24-hour excretion with an absolute increase of at least 200mg/24 hours of urine M-protein to qualify as \"progression\"\n   * Increase in bone marrow plasma cell percentage to ≥ 25% from lowest response value (the absolute % increase must be ≥ 10%)\n2. Any of the following felt related to the underlying clonal plasma cell proliferative disorder:\n\n   * Hypercalcemia (\\> 11 mg/dL)\n   * Decrease in hemoglobin of ≥ 2 gms/dL\n   * Serum creatinine level ≥ 2mg/dL\n   * Development of myeloma bone lesions or soft tissue plasmacytoma","dispersionType":"95% 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 III)"},{"description":"Patients undergo observation until progression to symptomatic myeloma.","id":"OG001","title":"Arm B (Observation; Phase III)"}],"paramType":"NUMBER","populationDescription":"All randomized patients","reportingStatus":"POSTED","timeFrame":"Assessed every 3 months for 2 years","title":"2-year Progression-free Survival (PFS) Rate (Phase III Primary Endpoint)","type":"PRIMARY","unitOfMeasure":"proportion of participants"}