Endpoints and Statistical Analysis
PD, death, non-clear
DISEASE, PATHOLOGY
The primary endpoint of the study in the overall population and within the randomized subset was based on ORR. As these data have been previously reported, we focused the current analysis on those patients with non-clear cell histology (note: pathology was investigator reported and not centrally confirmed). Investigator-assessed ORR at 16 weeks (mRECIST) in all patients is reported. Additionally, the best confirmed response (which required confirmation on a subsequent scan) and the best unconfirmed response (which included patients for whom a confirmatory scan was not evaluable or who did not demonstrate persistent response beyond one scan) per RECIST 1.0 were assessed in patients continuously treated with tivozanib. These results are presented for the non-clear cell population as a whole and by histologic subtype. PFS was estimated using the Kapan–Meier method for all treated nccRCC patients. For the analysis of PFS, patients who discontinued treatment without progressive disease (PD) or death were censored at their last assessment, and patients who were randomized to receive placebo were censored at the time of randomization.