Real-world safety and effectiveness of nivolumab for advanced renal cell carcinoma in Japan: a post-marketing surveillance.

ABSTRACT:

Background

This all-case post-marketing surveillance (PMS) evaluated the real-world safety and effectiveness of nivolumab monotherapy in Japanese patients with un-resectable or metastatic renal cell carcinoma (RCC).

Methods

This multicenter, open-label, non-interventional, observational PMS study (registered from August 2016 to January 2017) was conducted in patients who were newly initiated on nivolumab monotherapy. Assessments included treatment-related adverse events (TRAEs) of special interest, patient characteristics affecting safety, and effectiveness over 12 months.

Results

Overall, 580 patients were enrolled; 555 and 554 patients comprised the safety and effectiveness analysis sets, respectively. The median (range) age of the population was 66 (14-90) years. N

SUBMITTER: Uemura H 

PROVIDER: S-EPMC9119881 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature