{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"13"}]}],"title":"≥ 1 Adverse Event (AE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Adverse Event related to study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}],"title":"Adverse Event NCI CTC (Version2.0) Grade 3 or 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}],"title":"≥ 1 Serious Adverse Event (SAE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"≥ 1 AE leading to discontinuation of study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"≥ 1 AE leading to dose reduction/interruption"}],"denoms":[{"counts":[{"groupId":"OG000","value":"21"}],"units":"Participants"}],"description":"An AE is any sign, symptom, illness, or diagnosis (either observed or volunteered) that appears or worsens during the course of the study Serious adverse event (SAE) = any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event. A treatment emergent AE is defined as any AE occurring or worsening on or after the first dose of study drug and within 30 days after the last dose of study drug. Safety and severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 2.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal;","groups":[{"description":"Oral 25mg daily on Days 1-21 every 28 days","id":"OG000","title":"Lenalidomide 25mg (CC-5013)"}],"paramType":"NUMBER","populationDescription":"Included participants who were enrolled in the extension phase. The safety population included participants enrolled in the study and had received at least one dose of lenalidomide.","reportingStatus":"POSTED","timeFrame":"From 22 Oct 2009 to November 2013; AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit.","title":"Number of Participants With Adverse Events (AE) During the Extension Phase","type":"PRIMARY","unitOfMeasure":"participants"}