{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.9","upperLimit":"5.0","value":"3"},{"groupId":"OG001","lowerLimit":"1.8","upperLimit":"4.2","value":"3.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"26"}],"units":"Participants"}],"description":"Estimated probable duration of life without disease progression, from on-study date to earlier of progression date or date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details). Disease progression is defined under Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as \\>=20% increase in sum of longest diameters of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions.","dispersionType":"95% Confidence Interval","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":"MEDIAN","populationDescription":"All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where either death or progression is an event, with censoring for non-progressed, non-expired patients at greater of off-study date or last known alive date.","reportingStatus":"POSTED","timeFrame":"On-study date to lesser of date of progression or date of death from any cause (assessed up to 3 years)","title":"Progression Free Survival (PFS)","type":"PRIMARY","unitOfMeasure":"months"}