Covariate analysis
tumor, RCC
DISEASE, LIVER METASTASIS, TUMOR, RCC
Covariate effects were assessed for the PFS model. Covariates were added to the base model simultaneously to form a full model followed by stepwise backward elimination to identify the most parsimonious model. Statistical significance of covariate-parameter relationships was assessed with the Wald test, at Covariates evaluated were based on clinical judgment and mechanistic plausibility and included: age, baseline PD-L1 + tumor expression (≥ 1% vs. < 1% or indeterminate), baseline IMDC score (0 vs. 1–2 vs. 3–6), baseline Karnofsky performance status (≥ 90 vs. < 90), prior adjuvant or neo-adjuvant therapy for localized or locally advanced RCC (Yes vs. No), prior nephrectomy (Yes vs. No), prior radiotherapy (Yes vs. No), baseline lactate dehydrogenase (LDH) level (≤ 1.5 × upper limit of normal [ULN] vs. > 1.5 × ULN), time from initial disease diagnosis to randomization (< 1 year vs. ≥ 1 year), sex, baseline body weight, tumor burden (sum of the diameter of target lesions at baseline, > median vs. ≤ median), baseline albumin (5th percentile vs. median, 95th percentile vs. median), baseline nivolumab clearance (5th percentile vs. median, 95th percentile vs. median), and liver metastasis (Yes vs. No).