{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.63","value":"4.62"}]}],"title":"Change in NOD at Cycle 2 (n=52)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.69","value":"-2.40"}]}],"title":"Change in UOS at Cycle 2 (n=52)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.38","value":"2.88"}]}],"title":"change in EIP at Cycle 2 (n=52)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.58","value":"3.24"}]}],"title":"Change in NOD at Cycle 4 (n=34)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.63","value":"-0.71"}]}],"title":"Change in UOS at Cycle 4 (n=35)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.08","value":"-6.62"}]}],"title":"Change in EIP at Cycle 4 (n=34)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.78","value":"9.29"}]}],"title":"Change in NOD at Cycle 6 (n=28)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.57","value":"-1.79"}]}],"title":"Change in UOS at Cycle 6 (n=28)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"28.81","value":"-1.79"}]}],"title":"Change in EIP at Cycle 6 (n=28)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"32.29","value":"11.88"}]}],"title":"Change in NOD at monotherapy Cycle 2 (n=16)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.38","value":"-4.69"}]}],"title":"Change in UOS at monotherapy Cycle 2 (n=16)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"35.61","value":"-4.41"}]}],"title":"Change in EIP at monotherapy Cycle 2 (n=17)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.33","value":"8.89"}]}],"title":"Change in NOD at monotherapy Cycle 4 (n=9)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.20","value":"2.78"}]}],"title":"Change in UOS at monotherapy Cycle 4 (n=9)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.20","value":"2.78"}]}],"title":"Change in EIP at monotherapy Cycle 4 (n=9)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"52"}],"units":"Participants"}],"description":"PSS-HNC is a clinician-rated instrument designed to measure speaking and eating disabilities of participants with head and neck cancer and consists of 3 subscales: normalcy of diet (NOD) subscale measures the ability of the participants to eat a normal diet, subscale ranges from 0 (non-oral feeding) to 100 (unrestricted diet); understandability of speech (UOS) subscale measures the degree a clinician is able to understand the participant's speech, subscale ranges from 0 (never understandable) to 100 (always understandable); eating in public (EIP) subscale, rating based on the participant's response to the questions of whom he/she eats with and in what setting, subscale ranges from 0 (always eats alone) to 100 (no restriction of place, food, or companion). Change from baseline: negative value represents a decrease in function and a positive value represents an increase in function.","dispersionType":"Standard Deviation","groups":[{"description":"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered 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":"OG000","title":"Cetuximab + Pemetrexed + Carboplatin/Cisplatin"}],"paramType":"MEAN","populationDescription":"All treated participants who had PSS-HNC assessments at baseline and in Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4. Exclude those from a noncompliant study site.","reportingStatus":"POSTED","timeFrame":"Baseline, Day 1 of Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4 (21-day cycle)","title":"Change From Baseline in Performance Status Scale for Head and Neck Cancer (PSS-HNC)","type":"SECONDARY","unitOfMeasure":"units on a scale"}