{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"7"}]}],"title":"Number of Patients with Worst-Grade Toxicity 1"},{"categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"4"}]}],"title":"Number of Patients with Worst-Grade Toxicity 2"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"12"}]}],"title":"Number of Patients with Worst-Grade Toxicity 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"title":"Number of Patients with Worst-Grade Toxicity 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Number of Patients with Worst-Grade Toxicity 5"}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"24"}],"units":"Participants"}],"description":"Count of patients according to the worst-grade toxicity experienced by each, where worst-grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life-threatening; grade 5, death","groups":[{"description":"Patients were to receive cetuximab 400 mg/m\\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.","id":"OG000","title":"Arm A - Cetuximab"},{"description":"Patients received cetuximab 400 mg/m\\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.","id":"OG001","title":"Arm B - Cetuximab and Sorafenib Tosylate"}],"paramType":"NUMBER","populationDescription":"Total number of patients reported with any toxicity. Because not all patients experience a toxicity, and some experience more than one; the number of patients analyzed does not coincide with the number of patients on study.","reportingStatus":"POSTED","timeFrame":"On-study date to 30 days following final dose of study drug","title":"Number of Participants With Each Worst-Grade Toxicity","type":"SECONDARY","unitOfMeasure":"participants"}