{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"41.7","upperLimit":"79.2","value":"66.7"},{"groupId":"OG001","lowerLimit":"58.3","upperLimit":"75","value":"62.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"17"}],"units":"Participants"}],"title":"Emotion- Prior to treatment"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"41.7","upperLimit":"95.8","value":"66.7"},{"groupId":"OG001","lowerLimit":"75.0","upperLimit":"100","value":"95.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"title":"Emotion- 6 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"66.7","upperLimit":"83.3","value":"72.9"},{"groupId":"OG001","lowerLimit":"75","upperLimit":"100","value":"91.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"title":"Emotion- 12 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"52.1","upperLimit":"81.3","value":"75"},{"groupId":"OG001","lowerLimit":"91.7","upperLimit":"95.8","value":"91.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"title":"Emotion- 24 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"37.5","upperLimit":"62.5","value":"46.9"},{"groupId":"OG001","lowerLimit":"25","upperLimit":"68.8","value":"34.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"18"}],"units":"Participants"}],"title":"Speech- Prior to treatment"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"21.9","upperLimit":"78.1","value":"56.3"},{"groupId":"OG001","lowerLimit":"37.5","upperLimit":"81.3","value":"50"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"title":"Speech- 6 Months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"31.3","upperLimit":"75","value":"50"},{"groupId":"OG001","lowerLimit":"18.8","upperLimit":"87.5","value":"62.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"title":"Speech- 12 Months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"43.8","upperLimit":"75","value":"50"},{"groupId":"OG001","lowerLimit":"50","upperLimit":"87.5","value":"75"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"title":"Speech- 24 Months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"43.8","upperLimit":"75","value":"59.4"},{"groupId":"OG001","lowerLimit":"56.3","upperLimit":"87.5","value":"68.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"17"}],"units":"Participants"}],"title":"Pain- Prior to treatment"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"31.3","upperLimit":"87.5","value":"62.5"},{"groupId":"OG001","lowerLimit":"62.5","upperLimit":"87.5","value":"81.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"title":"Pain- 6 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"43.8","upperLimit":"91.7","value":"68.8"},{"groupId":"OG001","lowerLimit":"58.3","upperLimit":"87.5","value":"62.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"10"}],"units":"Participants"}],"title":"Pain- 12 months"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"28.1","upperLimit":"87.5","value":"56.3"},{"groupId":"OG001","lowerLimit":"75","upperLimit":"93.8","value":"87.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"title":"Pain- 24 months"}],"denoms":[{"counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"18"}],"units":"Participants"}],"description":"University of Michigan Head and Neck Quality of Life Instrument (HN-QOL) will be administered prior to treatment (i.e. pre-induction chemotherapy) and at 6 months, 12 months, and 24 months (+/- 4 months) after completion of chemo-RT or surgery-RT (or surgery-chemoRT, as indicated). Scale is 0-100 with high scores indicating a better outcome.","dispersionType":"Inter-Quartile Range","groups":[{"description":"platinum/docetaxel + AT-101 The platinum will either be cisplatin or carboplatin as deemed best by the medical oncologist.\n\nPatients underwent induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).\n\n(AT-101 Arm) Days #1-3: Patients received AT-101 40 mg orally twice daily On Day 23 (+/- 3 days), there will be a direct laryngoscopy (DL) with tumor biopsy and blood draw, repeat CT scan of the neck with perfusion within a week biopsy.\n\nAT-101: Patients received AT-101 40 mg orally two times a day.\n\nCisplatin: Cisplatin 100 mg/m2\n\nCarboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg","id":"OG000","title":"Platinum/Docetaxal + AT-101"},{"description":"Patients underwent induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).\n\nDay #23 (+/- 3 days): Patients underwent a direct laryngoscopy (DL) with biopsy. Patients also underwent a repeat CT scan of the neck with perfusion within a week (+/-) of their perspective biopsies.\n\nDocetaxel: Docetaxel (Taxotere) 75 mg/m2\n\nCisplatin: Cisplatin 100 mg/m2\n\nCarboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg","id":"OG001","title":"Active Comparator Arm"}],"paramType":"MEDIAN","populationDescription":"Number of participants analyzed varies below based on completion compliance","reportingStatus":"POSTED","timeFrame":"Up to 28 months post treatment","title":"Head and Neck Related Quality of Life (QOL)","type":"SECONDARY","unitOfMeasure":"units on a scale"}