{"analyses":[{"groupDescription":"PFS at 4 months in Arm A was compared with a 4-month historical control rate of 21.4%, using a one-sided test at the 0.05 significant level. The historical data appear in two publications, an ASCO abstract: Abidoye, ASCO Annual Meeting 2006: 5568, and de Souza, Davis, et al, Clin Cancer Res 2012; 18(8):2336-2343 (see Figure 1).","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"0.006","statisticalMethod":"Chi-squared"},{"groupDescription":"PFS at 4 months in Arm B was compared with a 4-month historical control rate of 21.4%, using a one-sided test at the 0.05 significant level. The historical data appear in two publications, an ASCO abstract: Abidoye, ASCO Annual Meeting 2006: 5568, and de Souza, Davis, et al, Clin Cancer Res 2012; 18(8):2336-2343 (see Figure 1).","groupIds":["OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.037","pValueComment":"1-sided.","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"28.3","upperLimit":"54.3","value":"41.3"},{"groupId":"OG001","lowerLimit":"22.6","upperLimit":"50.2","value":"36.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"40"}],"units":"Participants"}],"description":"PFS at 4 months in Arm A and Arm B will each be compared with a 4-month historical control rate of 21.4%. The historical data appears in two publications, an ASCO abstract: Abidoye, ASCO Annual Meeting 2006: 5568 and de Souza, Davis, et al, Clin Cancer Res 2012; 18(8):2336-2343.","dispersionType":"90% Confidence Interval","groups":[{"description":"Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Arm A (Cetuximab and Temsirolimus)"},{"description":"Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.","id":"OG001","title":"Arm B (Temsirolimus)"}],"paramType":"NUMBER","populationDescription":"Note: Each arm is separately compared to an historical rate of 21.4%, based on a one-sided test at the 0.05 significant level. Since the 90% CIs each exclude 21.4%, the 4-month PFS rate in both arms exceeds the fixed historical control rate.","reportingStatus":"POSTED","timeFrame":"From start of treatment to time of progression or death of any cause, assessed at 4 months","title":"PFS vs. Historical Control Cohort","type":"SECONDARY","unitOfMeasure":"percentage of participants"}