{"analyses":[{"ciNumSides":"TWO_SIDED","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.49","statisticalMethod":"t-test, 2 sided"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.70","value":"-1.70"},{"groupId":"OG001","spread":"1.74","value":"-3.41"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"44"}],"units":"Participants"}],"description":"Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)","dispersionType":"Standard Error","groups":[{"description":"Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.\n\nChemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.\n\ndocetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)\n\ncisplatin: 75 mg/m2 on day 1\n\nhydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)\n\nfluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)\n\nchemotherapy: See protocol for details\n\nradiotherapy: See protocol for details","id":"OG000","title":"Induction Plus Chemoradiotherapy"},{"description":"Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks.\n\ndocetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)\n\nhydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)\n\nfluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)\n\nchemotherapy: See protocol for details\n\nradiotherapy: See protocol for details","id":"OG001","title":"Chemoradiotherapy"}],"paramType":"MEAN","populationDescription":"Survivors who completed the questionnaire. (Patients with missing data excluded.)","reportingStatus":"POSTED","timeFrame":"Change from baseline to 1 year (1 year-pre)","title":"Quality of Life (Speech)","type":"SECONDARY","unitOfMeasure":"units on a scale"}