*The influence of demographic and baseline clinical characteristics on disease-free survival among randomised patients was assessed via exploratory subgroup analyses for age, sex, race, ethnicity, region, ECOG performance status, type of nephrectomy, TNM staging, risk group, Fuhrman grade, Sarcomatoid features, time from diagnosis to randomisation, lactate dehydrogenase level, haemoglobin, corrected calcium, and alkaline phosphatase. HR was not computed for subset (except age, race, region, and sex) category with fewer than 11 patients per treatment group.
†The statistical analysis plan prespecified that subgroup analyses for stratification factors (TNM staging and type of nephrectomy) would only be displayed using subgroups based on case report form data. Analysis of disease-free survival by high and moderate risk groups and by Fuhrman grade were also per case report form.
‡Disease-free survival was assessed in the high and moderate risk subgroups using the following risk staging system: high risk (pT3, G3 or G4, N0 M0; pT4, Gany, N0 M0; pTany, Gany, N1 M0) and moderate risk (pT2a, G3 or G4, N0 M0; pT2b, Gany, N0 M0; pT3, G1 and G2, N0 M0).
DFS=disease-free survival. ECOG=Eastern Cooperative Oncology Group. LDH=lactate dehydrogenase. LLN=lower limit of normal. ULN=upper limit of normal.