{"analyses":[{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.223","pValueComment":"P-value is for Change at End of Triplet Combination Therapy. Threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","testedNonInferiority":false},{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.788","pValueComment":"P-value is for Change at End of Maintenance Therapy. Threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.230","value":"0.05"}]}],"title":"Change at End of Triplet Therapy (n=29)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.291","value":"-0.02"}]}],"title":"Change at End of Maintenance Therapy (n=15)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"34"}],"units":"Participants"}],"description":"EQ-5D Index is derived by converting the Descriptive System (participant is required to rate health by checking 1 \\[no limitation\\], 2 \\[some limitation\\] or 3 \\[severe or complete limitation\\] in 5 dimensions \\[mobility, self-care, usual activities, pain/comfort and anxiety/depression\\]) to a single summary index. A utility value assigned to each individual's health state based on the absence or presence of moderate or severe problems in the 5 dimensions. A regression equation defines a utility value for these health states. The possible values for health utility ranged from -0.59 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 0 represents death and 1 represents the best possible health state. Possible change values range from -1.59 (no problems at baseline to severe problems at visit) to 1.59 (severe problems at baseline to no problems at visit).","dispersionType":"Standard Deviation","groups":[{"description":"Pemetrexed 500 mg/m\\^2 administered by IV infusion followed by cisplatin 75 mg/m\\^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m\\^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m\\^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.","id":"OG000","title":"Pemetrexed Cisplatin Cetuximab"}],"paramType":"MEAN","populationDescription":"PQ Population: all randomized and treated participants with EQ-5D data at respective timepoint.","reportingStatus":"POSTED","timeFrame":"Baseline, End of Triplet Combination Therapy (up to 6 cycles [4.2 months]) , End of Maintenance Therapy (up to 18.7 months)","title":"Change From Baseline in Participant Reported EQ-5D Utility Score at End of Triplet Combination Therapy and End of Maintenance Therapy","type":"SECONDARY","unitOfMeasure":"units on a scale"}