{"analyses":[{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.697","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":"0.132","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":"14.28","value":"-1.2"}]}],"title":"Change at End of Triplet Therapy (n=23)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.51","value":"-10.6"}]}],"title":"Change at End of Maintenance Therapy (n=11)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"26"}],"units":"Participants"}],"description":"Vertical VAS - a 20 millimeter (mm), fractionated scale in the form of a thermometer with endpoints of 0 (worst imaginable health state) and 100 (best imaginable health state). Participants used the EQ-5D VAS scale to rate their overall health on the day the questionnaire was administered. Possible change values range from -100 (best imaginable health at baseline changed to worst possible health at visit) to 100 (worst possible health at baseline changed to best possible health 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 evaluable data for each category","reportingStatus":"POSTED","timeFrame":"Baseline, End of Triplet Combination Therapy (up to Cycle 6 [4.2 months]), End of Maintenance Therapy (up to 18.7 months)","title":"Change From Baseline in Participant Reported European-Quality of Life 5 Dimension Instrument (EQ-5D) Visual Analog Scale (VAS) at End of Triplet Combination Therapy and End of Maintenance Therapy","type":"SECONDARY","unitOfMeasure":"units on a scale"}