{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"3.519","value":"50.74"},{"groupId":"OG001","spread":"3.745","value":"45.15"}]}],"title":"At baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"3.724","value":"52.68"},{"groupId":"OG001","spread":"4.153","value":"45.48"}]}],"title":"At cycle 3"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"4.282","value":"55.30"},{"groupId":"OG001","spread":"5.959","value":"42.49"}]}],"title":"Month 6"}],"denoms":[{"counts":[{"groupId":"OG000","value":"152"},{"groupId":"OG001","value":"139"}],"units":"Participants"}],"description":"Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.","dispersionType":"Standard Error","groups":[{"description":"Subjects in will receive initial dose of 400 mg/m\\^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m\\^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m\\^2 on day 1) + 5-FU (1000 mg/m\\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m\\^2 continuous IV from day 1 to day 4) every 3 weeks.","id":"OG000","title":"Cetuximab Plus Chemotherapy"},{"description":"All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m\\^2 on day 1) + 5-FU (1000 mg/m\\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m\\^2 continuous IV from day 1 to day 4) every 3 weeks.","id":"OG001","title":"Chemotherapy Alone"}],"paramType":"LEAST_SQUARES_MEAN","populationDescription":"Of 361 ITT subjects from countries with EORTC QLQ-C30 available, 291 completed ≥1 evaluable questionnaire. Only time points where ≥ 20% of patients completing a baseline questionnaire remained in the population were analysed. Numbers at each timepoint were (cetuximab+chemotherapy/chemotherapy alone): Baseline: 121/106; Cycle3:87/67; Month6:48/22","reportingStatus":"POSTED","timeFrame":"at baseline, day 1 of cycle 3, first 6-weekly evaluation following completion of chemotherapy, 6 & 12 months after randomization, reported between day of first patient randomised, 21 Dec 2004,until cut-off date, 12 Mar 2007","title":"Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status","type":"SECONDARY","unitOfMeasure":"scores on a scale"}