{"denoms":[{"counts":[{"groupId":"BG000","value":"36"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"54"}],"units":"Participants"}],"groups":[{"description":"platinum/docetaxel + AT-101 The platinum will either be cisplatin or carboplatin as deemed best by the medical oncologist.\n\n(Both Arms) Day #1: Patients will undergo 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 will receive 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 will receive 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\n\nPer physician discretion, carboplatin was used in lieu of cisplatin for 13 patients in this arm","id":"BG000","title":"Platinum/Docetaxal + AT-101"},{"description":"(Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).\n\nDay #23 (+/- 3 days): Patients will undergo a direct laryngoscopy (DL) with biopsy. Patients will also undergo 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\nPer physician discretion, carboplatin was used in lieu of cisplatin for 10 patients in this arm Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg","id":"BG001","title":"Active Comparator Arm"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"<=18 years"},{"measurements":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"38"}],"title":"Between 18 and 65 years"},{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"16"}],"title":">=65 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"19","upperLimit":"82","value":"58.5"},{"groupId":"BG001","lowerLimit":"33","upperLimit":"77","value":"61.4"},{"groupId":"BG002","lowerLimit":"19","upperLimit":"82","value":"59.95"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"8"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"46"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"35"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"53"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"36"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"54"}]}],"title":"United States"}],"paramType":"NUMBER","title":"Region of Enrollment","unitOfMeasure":"participants"}]}