{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"100.0"},{"groupId":"OG001","value":"99.1"},{"groupId":"OG002","value":"93.4"},{"groupId":"OG003","value":"100.0"}]}],"title":"1 or more (1+) AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"89.3"},{"groupId":"OG001","value":"87.9"},{"groupId":"OG002","value":"68.9"},{"groupId":"OG003","value":"88.8"}]}],"title":"1+ AE related to pomalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"88.4"},{"groupId":"OG001","value":"84.1"},{"groupId":"OG002","value":"70.5"},{"groupId":"OG003","value":"89.7"}]}],"title":"1+ severity grade 3-4 AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"62.5"},{"groupId":"OG001","value":"58.9"},{"groupId":"OG002","value":"44.3"},{"groupId":"OG003","value":"67.3"}]}],"title":"1+ severity grade 3-4 AE related to pomalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"61.6"},{"groupId":"OG001","value":"46.7"},{"groupId":"OG002","value":"47.5"},{"groupId":"OG003","value":"67.3"}]}],"title":"1+ serious AE (SAE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"17.9"},{"groupId":"OG001","value":"9.3"},{"groupId":"OG002","value":"19.7"},{"groupId":"OG003","value":"20.6"}]}],"title":"1+ SAE related to pomalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8.0"},{"groupId":"OG001","value":"10.3"},{"groupId":"OG002","value":"3.3"},{"groupId":"OG003","value":"12.1"}]}],"title":"1+ AE leading to discontinuation of pomalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1.8"},{"groupId":"OG001","value":"2.8"},{"groupId":"OG002","value":"1.6"},{"groupId":"OG003","value":"3.7"}]}],"title":"1+related AE --discontinuation of pomalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"20.5"},{"groupId":"OG001","value":"25.2"},{"groupId":"OG002","value":"9.8"},{"groupId":"OG003","value":"29.9"}]}],"title":"1+AE - reduction of pomalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"63.4"},{"groupId":"OG001","value":"47.7"},{"groupId":"OG002","value":"36.1"},{"groupId":"OG003","value":"58.9"}]}],"title":"1+ AE - interruption of pomalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"27.7"},{"groupId":"OG001","value":"24.3"},{"groupId":"OG002","value":"21.3"},{"groupId":"OG003","value":"32.7"}]}],"title":"1+ related AE - interruption of pomalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"17.9"},{"groupId":"OG001","value":"20.6"},{"groupId":"OG002","value":"8.2"},{"groupId":"OG003","value":"24.3"}]}],"title":"1+related AE - reduction of pomalidomide"}],"denoms":[{"counts":[{"groupId":"OG000","value":"112"},{"groupId":"OG001","value":"107"},{"groupId":"OG002","value":"61"},{"groupId":"OG003","value":"107"}],"units":"Participants"}],"description":"Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.\n\nData collection is ongoing and future data results will be included as available.","groups":[{"description":"Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.","id":"OG000","title":"Phase 2: Pomalidomide + Dexamethasone"},{"description":"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.\n\nData are reported during the time when participants were on pomalidomide alone, before dexamethasone was added.","id":"OG001","title":"Phase 2: Pomalidomide (Pom Only)"},{"description":"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.\n\nData are reported during the time after PD when participants were on both pomalidomide and dexamethasone.","id":"OG002","title":"Phase 2: Pomalidomide (Pom + Dex Only)"},{"description":"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.\n\nData are reported during the entire study up to the data cut-off, thus including both the time participants were only on pomalidomide and the time after PD when participants were on pomalidomide and dexamethasone.","id":"OG003","title":"Phase 2: Pomalidomide (Overall)"}],"paramType":"NUMBER","populationDescription":"Safety population.\n\nData collection is ongoing and future data results will be included as available.","reportingStatus":"POSTED","timeFrame":"Up to week 70","title":"Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as of the 01 April 2011 Cut-off","type":"SECONDARY","unitOfMeasure":"percentage of participants"}