{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Complete response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Partial response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"Stable disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"}]}],"title":"Progression"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"}]}],"title":"Unevaluable"}],"denoms":[{"counts":[{"groupId":"OG000","value":"22"}],"units":"Participants"}],"description":"This outcome measure reports the best response a patient has ever experienced.\n\n\\<Target Lesions\\>\n\nComplete Response (CR):\n\nThe disappearance of all target lesions, confirmed by assessments \\>=4 weeks (wks) later.\n\nPartial Response:\n\n\\>=30% decrease in the sum of the longest diameters of target lesions from baseline, confirmed by assessments \\>=4 wks later.\n\nProgressive Disease (PD):\n\n\\>=20% increase in the sum of the longest diameters of target lesions from the smallest sum longest diameter since baseline, or the appearance of new lesions.\n\nStable Disease (SD):\n\nNeither response criteria nor progressive disease criteria are met for \\>=8 wks.\n\n\\<Nontarget Lesions\\>\n\nCR:\n\nThe disappearance of all nontarget lesions and normalization of tumor marker levels, confirmed by assessments \\>=4 wks later.\n\nSD:\n\nPersistence of nontarget lesions or maintenance of tumor marker levels above the normal limits for \\>=8 wks.\n\nPD:\n\nThe appearance of new lesions or unequivocal progression of existing lesions.","groups":[{"description":"Only eligible and treated patients are included in the analysis.\n\nBAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies.","id":"OG000","title":"TCC Cohort"}],"paramType":"NUMBER","populationDescription":"Only eligible and treated patients are included in the analysis.","reportingStatus":"POSTED","timeFrame":"Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 1 year.","title":"Best Overall Response by RECIST","type":"SECONDARY","unitOfMeasure":"Participants"}