{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"174"},{"groupId":"OG001","value":"173"}]}],"title":"Any TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"159"},{"groupId":"OG001","value":"118"}]}],"title":"Any TEAE Related to Lenalidomide/Placebo (LEN/PBO)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"134"},{"groupId":"OG001","value":"105"}]}],"title":"Any TEAE Related to Rituximab (RIT)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"45"},{"groupId":"OG001","value":"25"}]}],"title":"Any Serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"8"}]}],"title":"Any Serious TEAE Related to LEN/PBO"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"4"}]}],"title":"Any Serious TEAE Related to RIT"},{"categories":[{"measurements":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"58"}]}],"title":"Any CTCAE Grade (GR) 3/4 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"101"},{"groupId":"OG001","value":"38"}]}],"title":"Any CTCAE GR 3/4 TEAE Related to LEN/PBO"},{"categories":[{"measurements":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"20"}]}],"title":"Any CTCAE GR 3/4 TEAE Related to RIT"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"}]}],"title":"Any GR 5 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"6"}]}],"title":"Any TEAE Leading to Dose Reduction LEN/PBO"},{"categories":[{"measurements":[{"groupId":"OG000","value":"113"},{"groupId":"OG001","value":"47"}]}],"title":"Any TEAE Leading to Dose Interruption LEN/PBO"},{"categories":[{"measurements":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"38"}]}],"title":"Any TEAE Leading to Dose Interruption RIT"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"9"}]}],"title":"Any TEAE Leading to Discontinuation of LEN/PBO"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"2"}]}],"title":"Any TEAE Leading to Discontinuation of RIT"}],"denoms":[{"counts":[{"groupId":"OG000","value":"176"},{"groupId":"OG001","value":"180"}],"units":"Participants"}],"description":"TEAEs include AEs that started or worsened between the date of the first dose and 28 days after the date of the last dose. A serious adverse event (SAE) is any: • Death; • Life-threatening event; • Any inpatient hospitalization or prolongation of existing hospitalization; • Persistent or significant disability or incapacity; • Congenital anomaly or birth defect; • Any other important medical event. The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event. The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 4.03) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death","groups":[{"description":"Participants received rituximab 375 mg/m\\^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but \\< 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.","id":"OG000","title":"Rituximab + Lenalidomide (R^2)"},{"description":"Participants received rituximab 375 mg/m\\^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.","id":"OG001","title":"Rituximab + Placebo"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The safety population was defined as all participants who have received at least one dose of study medication.","reportingStatus":"POSTED","timeFrame":"From first dose to 28 days post last dose (Average of 55.71 months and a maximum up to 95.2 months)","title":"Number of Participants With Treatment Emergent Adverse Events (TEAEs)","type":"SECONDARY","unitOfMeasure":"Participants"}