{"denoms":[{"counts":[{"groupId":"BG000","value":"36"}],"units":"Participants"}],"groups":[{"description":"Pomalidomide: 4 mg oral pomalidomide once daily Days 1-21 of each 28-day cycle Dexamethasone: 40 mg or 20 mg oral dexamethasone once daily on Days 1, 8, 15, 22 of each 28-day cycle","id":"BG000","title":"Pomalidomide Plus Dexamethasone"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"43","upperLimit":"78","value":"64.5"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"32"}]}],"title":"≤ 75 Years Old"},{"categories":[{"measurements":[{"groupId":"BG000","value":"4"}]}],"title":"> 75 Years Old"}],"paramType":"NUMBER","title":"Age, Customized","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"20"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"16"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"36"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"0.6","upperLimit":"21.1","value":"4.65"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Time from first diagnosis","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"7"}]}],"title":"Stage I"},{"categories":[{"measurements":[{"groupId":"BG000","value":"16"}]}],"title":"Stage II"},{"categories":[{"measurements":[{"groupId":"BG000","value":"13"}]}],"title":"Stage III"}],"description":"Stages are: Stage I: Hemoglobin \\> 10 g/dL Serum calcium normal On roentgenogram, normal bone structure or solitary bone plasmacytoma only Low M-component production rates (IgG value \\< 5 g/dL, IgA value \\< 3 g/dL, Bence Jones protein \\< 4 g/24h) Stage II: Overall data as minimally abnormal for stage I, and no single value as abnormal as defined for stage III Stage III: 1 or more of below: Hemoglobin \\< 8.5 g/dL Serum calcium \\> 12 mg/dL Advanced lytic bone lesions (scale 3) High-M-component production rates (IgG value \\> 7 g/dL, IgA value \\> 5 g/dL, Bence Jones protein \\> 12 g/24h)","paramType":"NUMBER","title":"Durie-Salmon Multiple myeloma staging at screening","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"17"}]}],"title":"0 = (Asymptomatic)"},{"categories":[{"measurements":[{"groupId":"BG000","value":"16"}]}],"title":"1 = (Symptomatic but completely ambulatory)"},{"categories":[{"measurements":[{"groupId":"BG000","value":"3"}]}],"title":"2 = (Ambulatory but unable to work)"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}]}],"title":"3 = (Limited self-care)"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}]}],"title":"4 = (Completely disabled)"}],"description":"The ECOG scale is as follows: Grade 0: Fully active, able to carry on all pre-disease activities without restriction; Grade 1: Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair \\> 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or chair.","paramType":"NUMBER","title":"Eastern Cooperative Oncology Group Performance Status] (ECOG)","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"2","upperLimit":"14","value":"6.0"}]}]}],"description":"The number of prior chemotherapy regimens for myeloma","dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Prior Chemotherapy Regimens","unitOfMeasure":"regimens"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"19"}]}],"title":"Yes"},{"categories":[{"measurements":[{"groupId":"BG000","value":"17"}]}],"title":"No"}],"paramType":"NUMBER","title":"Prior Stem Cell Transplant for Myeloma","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"7"}]}],"title":"Stage I"},{"categories":[{"measurements":[{"groupId":"BG000","value":"16"}]}],"title":"Stage II"},{"categories":[{"measurements":[{"groupId":"BG000","value":"13"}]}],"title":"Stage III"}],"description":"Stages are: Stage I: Hemoglobin \\> 10 g/dL Serum calcium normal On roentgenogram, normal bone structure or solitary bone plasmacytoma only Low M-component production rates (IgG value \\< 5 g/dL, IgA value \\< 3 g/dL, Bence Jones protein \\< 4 g/24h) Stage II: Overall data as minimally abnormal for stage I, and no single value as abnormal as defined for stage III Stage III: 1 or more of below: Hemoglobin \\< 8.5 g/dL Serum calcium \\> 12 mg/dL Advanced lytic bone lesions (scale 3) High-M-component production rates (IgG value \\> 7 g/dL, IgA value \\> 5 g/dL, Bence Jones protein \\> 12 g/24h)","paramType":"NUMBER","title":"Durie-Salmon Multiple Myeloma staging at screening","unitOfMeasure":"participants"}],"populationDescription":"Safety Population included all participants who received at least one dose of study medication"}