Adverse events reporting, monitoring and interim analysis
ADVERSE EVENTS, ADVERSE EVENT
On-site monitoring was performed at each hospital by monitors appointed by the monitoring committee. Central monitoring was also conducted. Adverse events were reported on medical records and EDC, with causal associations with intervention drugs, dates, severity, with/without any treatments and outcomes. Serious adverse events were immediately reported to the principal investigator, who then reported them to The Certified Review Board and Minister of Health, Labour and Welfare. The Certified Review Board had the power to stop the study when a marked difference was noted in safety based on reports of serious adverse events or safety monitoring. Other adverse events were reported on EDC. Spontaneous reporting was used over the course of the trial to non-systematically collect these adverse events. An efficacy interim analysis was not performed because this study was a non-inferiority RCT.