{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.59","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.3","upperLimit":"32.8","value":"17.5"},{"groupId":"OG001","lowerLimit":"12.7","upperLimit":"41.1","value":"25"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"40"}],"units":"Participants"}],"description":"Incidence of hematological toxicities at least possibly related to study drug, graded based on Common Terminology Criteria for Adverse Events version 4","dispersionType":"95% 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","reportingStatus":"POSTED","timeFrame":"Up to 5 years","title":"Grade 3 or Higher Hematological Toxicity","type":"SECONDARY","unitOfMeasure":"percentage of participants"}