{"denoms":[{"counts":[{"groupId":"BG000","value":"69"}],"units":"Participants"}],"groups":[{"description":"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² intravenously weekly.\n\nPemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.\n\nCarboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.\n\nMaximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.","id":"BG000","title":"Cetuximab + Pemetrexed + Carboplatin/Cisplatin"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"10.3","value":"61.9"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"12"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"57"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"63"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"1"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"1"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"1"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"11"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"56"}],"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","value":"69"}]}],"title":"United States"}],"paramType":"NUMBER","title":"Region of Enrollment","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"0.248","value":"0.721"}]}],"title":"Index Score (n=47)"},{"categories":[{"measurements":[{"groupId":"BG000","spread":"20.658","value":"66.106"}]}],"title":"Visual Analog Scale (VAS) Score (n=47)"}],"description":"Participants assessed health-related QoL in 5 D (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) as no problems/some or moderate problems/extreme problems. A regression equation defines a utility value for these health states to generate an index score from -0.594 (severe problems in all 5 D) to 1 (no problem in all 5 D) where 1=best possible health state. EQ-5D VAS rates participant's current health-related QoL on the day of questionnaire administration and is captured on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state).","dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L)","unitOfMeasure":"units on a scale"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"37.87","value":"56.32"}]}],"title":"NOD (n=57)"},{"categories":[{"measurements":[{"groupId":"BG000","spread":"32.20","value":"78.51"}]}],"title":"UOS (n=57)"},{"categories":[{"measurements":[{"groupId":"BG000","spread":"34.42","value":"71.93"}]}],"title":"EIP (n=57)"}],"description":"Clinician measured speaking and eating disabilities of HNC participants that consists 3 subscales: normalcy of diet (NOD) measures ability of eating a normal diet, scale from 0 (non-oral feeding) to 100 (unrestricted diet); understandability of speech (UOS) measures the degree a clinician was able to understand participant's speech, scale from 0 (never understandable) to 100 (always understandable); eating in public (EIP) is based on clinician's question to the participant, scale from 0 (always eats alone) to 100 (no restriction of place, food, or companion).","dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Performance Status Scale for Head and Neck Cancer (PSS-HNC)","unitOfMeasure":"units on a scale"}],"populationDescription":"All enrolled participants who received at least 1 dose of study drug."}