{"denoms":[{"counts":[{"groupId":"BG000","value":"451"},{"groupId":"BG001","value":"452"},{"groupId":"BG002","value":"903"}],"units":"Participants"}],"groups":[{"description":"Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.","id":"BG000","title":"Sorafenib (Nexavar, BAY43-9006)"},{"description":"Subjects received matching placebo tablets administered orally twice a day. \\[until \\~31 May 2005\\]","id":"BG001","title":"Placebo"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"19.0","upperLimit":"86.0","value":"58.0"},{"groupId":"BG001","lowerLimit":"29.0","upperLimit":"84.0","value":"59.0"},{"groupId":"BG002","lowerLimit":"19.0","upperLimit":"86.0","value":"59.0"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"Years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"304"},{"groupId":"BG001","value":"328"},{"groupId":"BG002","value":"632"}]}],"title":"<65 years"},{"categories":[{"measurements":[{"groupId":"BG000","value":"147"},{"groupId":"BG001","value":"124"},{"groupId":"BG002","value":"271"}]}],"title":">= 65 years"}],"paramType":"NUMBER","title":"Age, Customized","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"136"},{"groupId":"BG001","value":"112"},{"groupId":"BG002","value":"248"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"315"},{"groupId":"BG001","value":"340"},{"groupId":"BG002","value":"655"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"234"},{"groupId":"BG001","value":"219"},{"groupId":"BG002","value":"453"}]}],"title":"Low"},{"categories":[{"measurements":[{"groupId":"BG000","value":"217"},{"groupId":"BG001","value":"232"},{"groupId":"BG002","value":"449"}]}],"title":"Intermediate"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]}],"title":"Missing"}],"description":"The Motzer score risk factors predicting survival in participants with metastatic RCC are as following: • Low ECOG performance status (PS\\>2) • High lactate dehydrogenase (\\>1.5 times upper limit of normal) • Low serum hemoglobin (\\<lower limit of normal) • High corrected serum calcium (\\>10 mg/dL) • Absence of prior nephrectomy factors.","paramType":"NUMBER","title":"Motzer Category (Low, intermediate or high)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"219"},{"groupId":"BG001","value":"211"},{"groupId":"BG002","value":"430"}]}],"title":"PS 0"},{"categories":[{"measurements":[{"groupId":"BG000","value":"223"},{"groupId":"BG001","value":"235"},{"groupId":"BG002","value":"458"}]}],"title":"PS 1"},{"categories":[{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"11"}]}],"title":"PS 2"},{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"4"}]}],"title":"Missing"}],"description":"ECOG = Eastern cooperative oncology group PS levels are 0 (Fully active, able to carry on all pre-disease performance), 1 (ambulatory and able to carry out work of a light or sedentary), 2 (Ambulatory and capable of all selfcare but unable to carry out any work activities), 3 (Capable of only limited selfcare, confined to bed or chair more than 50% of awake time), 4 (Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair) and 5 (death).","paramType":"NUMBER","title":"ECOG Performance Status (PS)","unitOfMeasure":"Participants by scale"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"32"}]}],"title":"Stage III"},{"categories":[{"measurements":[{"groupId":"BG000","value":"433"},{"groupId":"BG001","value":"438"},{"groupId":"BG002","value":"871"}]}],"title":"Stage IV"}],"description":"TNM=Tumor, primary (T); Nodes, regional lymph nodes (N); Metastasis, distant (M). T0/N0/M0=no evidence of aspect. N1=metastasis in single regional lymph node, M1=distant metastasis. T1=tumor 7 cm or less in greatest dimension limited to kidney. T2= tumor \\>7 cm in greatest dimension limited to kidney. T3=tumor extends into major veins, invades adrenal gland, or peripheric tissues but not beyond Gerota's fascia. T4=tumor invades beyond Gerota's fascia. \\[Stage I: T1, N0, M0\\]\\[Stage II=T2, N0, M0\\]\\[Stage IV=T4, N0, M0; T4, N1, M0; any T, N2, M0; any T, any N, M1\\]\\[Stage III=remaining combinations\\]","paramType":"NUMBER","title":"TNM Classification at study entry","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"449"},{"groupId":"BG001","value":"447"},{"groupId":"BG002","value":"896"}]}],"title":"Clear Cell"},{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"4"}]}],"title":"Papillary"},{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"3"}]}],"title":"Granular"}],"description":"Histopathological characterization of renal cell carcinomas that subjects had included clear cell, papillary or granular carcinomas. Clear cell renal cell carcinoma is a renal cortical tumor typically characterized by malignant epithelial cells with clear cytoplasm and a compact-alveolar (nested) or acinar growth pattern interspersed with intricate, arborizing vasculature.\n\nTumors in which eosinophilic cells predominate were classified as \"granular cell\" carcinoma.\n\nPapillary renal cell carcinoma is an uncommon subtype that has distinctive gross, histologic, and cytogenetic features.","paramType":"NUMBER","title":"Cancer Subtypes","unitOfMeasure":"Participants with carcinoma type"}]}