{"denoms":[{"counts":[{"groupId":"BG000","value":"51"},{"groupId":"BG001","value":"49"},{"groupId":"BG002","value":"100"}],"units":"Participants"}],"groups":[{"description":"Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.","id":"BG000","title":"CC-486 and Pembrolizumab (CC-486 + PBZ)"},{"description":"Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.","id":"BG001","title":"Placebo and Pembrolizumab (PBO + PBZ)"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"10.03","value":"62.8"},{"groupId":"BG001","spread":"9.89","value":"64.9"},{"groupId":"BG002","spread":"9.96","value":"63.9"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","populationDescription":"The Intent-to-Treat population includes all participants who were randomized.","title":"Age, Continuous","unitOfMeasure":"Years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"43"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"26"},{"groupId":"BG001","value":"31"},{"groupId":"BG002","value":"57"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The Intent-to-Treat population includes all participants who were randomized.","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"5"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"42"},{"groupId":"BG001","value":"45"},{"groupId":"BG002","value":"87"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"7"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The Intent-to-Treat population includes all participants who were randomized.","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"17"},{"groupId":"BG002","value":"32"}],"title":"0 = Fully Active"},{"measurements":[{"groupId":"BG000","value":"36"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"68"}],"title":"1 = Restrictive but ambulatory"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"2 = ambulatory but unable to work"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"3 = limited self-care"}]}],"description":"ECOG performance status is used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living activities of the participant, and determine appropriate treatment and prognosis. 0 = Fully Active (Most Favorable Activity); 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, No self-care (Least Favorable Activity)","paramType":"COUNT_OF_PARTICIPANTS","title":"Eastern Cooperative Oncology Group (ECOG) Performance Status","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"5"}],"title":"Stage I"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"4"}],"title":"Stage II"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"6"}],"title":"Stage IIIA"},{"measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"15"}],"title":"Stage IIIB"},{"measurements":[{"groupId":"BG000","value":"38"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"70"}],"title":"Stage IV"}]}],"description":"Disease Stage means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body). Stage 0 - the cancer has not spread beyond the inner lining of the lung Stage I - the cancer is small and hasn't spread to the lymph nodes Stage II - the cancer has spread to some lymph nodes near the original tumor Stage III - the cancer has spread to nearby tissue or spread to far away lymph nodes Stage IV - the cancer has spread to other organs of the body such as the other lung, brain, or liver.","paramType":"COUNT_OF_PARTICIPANTS","title":"Stage at Primary Diagnosis","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"18"}],"title":"Squamous cell carcinoma"},{"measurements":[{"groupId":"BG000","value":"38"},{"groupId":"BG001","value":"36"},{"groupId":"BG002","value":"74"}],"title":"Adenocarcinoma"},{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"8"}],"title":"Other"}]}],"description":"The different types of lung cancer are described histologically by the types of cells the pathologist sees under the microscope. There are three major types of non-small cell lung cancer: Adenocarcinoma Squamous cell lung cancer (also called epidermoid carcinoma) Large cell lung cancer (Other)","paramType":"COUNT_OF_PARTICIPANTS","title":"Histology","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"1.33","value":"3.1"},{"groupId":"BG001","spread":"1.25","value":"2.8"},{"groupId":"BG002","spread":"1.29","value":"3.0"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Number of Metastatic Sites","unitOfMeasure":"Metastatic sites"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"18"}]}],"title":"Squamous Cell Carcinoma"},{"categories":[{"measurements":[{"groupId":"BG000","value":"42"},{"groupId":"BG001","value":"40"},{"groupId":"BG002","value":"82"}]}],"title":"Non-Squamous Cell Carcinoma"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Number of Participants Randomized by Strata","unitOfMeasure":"Participants"}],"populationDescription":"The Intent-to-Treat (ITT) population includes all participants who were randomized, regardless of whether they received assigned treatment or not"}