Safety
hyperkalemia
ADVERSE EVENTS
Throughout the study, safety information will be collected from all participants by recording adverse events (AEs), including hyperkalemia, irrespective of severity, and their causal associations to the trial drugs and protocol. In cases of AEs, local investigators must assess the severity or grade of AEs, procedures conducted, outcomes, and their associations to finerenone. In addition, local investigators must immediately report AEs to the secretariat who, in turn, will promptly report to the Certified Review Board of Fukushima Medical University in accordance with the Clinical Trial Act in Japan, if needed.