Abstract Sodium-glucose co-transporter-2 inhibitors (SGLT2-Is) have consistently
demonstrated a clinically significant reduction of cardiovascular mortality. However, their …

Spontaneous reporting systems remain pivotal for post-marketing surveillance and
disproportionality analysis (DA) represents a recognized approach for early signal detection …

Background Most pharmacovigilance departments maintain a system to identify adverse
drug reactions (ADRs) through analysis of spontaneous reports. The signal detection …

Abstract Background Immune checkpoint inhibitors (ICIs), including antibodies targeting
cytotoxic T-lymphocyte associated protein 4 (CTLA4) and programmed cell death 1 or its …

Purpose Characterize ocular adverse events (oAEs) caused by immune checkpoint
inhibitors (ICIs). Methods Retrospective analysis of 41,674 cancer patients in the FDA …

Aims The aim of this study was to characterise clinical priority of adverse events with
sacubitril/valsartan for targeting preventive measures. Methods We used the US Food and …

Abstract Background and Objective Spontaneous reporting systems (SRSs) remain the
cornerstone of post-marketing drug safety surveillance despite their well-known limitations …

Pharmacovigilance and risk minimization must be planned during drug development and
forms a critical part of the regulator's decision on whether a medicinal product can be …

This chapter aims to describe current and emerging roles of spontaneous reporting systems
(SRSs) for assessing and monitoring drug safety. Moreover, it offers a perspective on the …

Purpose Disproportionality screening analysis is acknowledged as a tool for performing
signal detection in databases of adverse drug reactions (ADRs), eg, in the European Union …