Objective: To analyse the potential impact of patients' sex, race, and region/country on the risk of hypersensitivity reactions after intra-venous or intra-arterial administration of iopromide.
Methods: Two analyses were performed. (1) The "Phase-IV-Analysis" evaluated an integrated pooled database of 4 non-interventional studies.
Background: Gadobutrol has been administered more than 100 million times worldwide, since February 1998, that is, over the last 25 years. Numerous clinical studies in a broad range of indications document the long-term experience with gadobutrol.
Objective: The aim of this study was to provide a literature-based overview on gadobutrol's efficacy in 9 approved indications and use in children.
Background: Contrast-enhanced mammography (CEM) is an emerging breast imaging modality. Clinical data is scarce.
Objectives: To summarize clinical evidence on the use of iopromide in CEM for the detection or by systematically analyzing the available literature on efficacy and safety.
Introduction: Signal validation in pharmacovigilance is the process of evaluating data to decide whether evidence is sufficient to justify further assessment of a detected signal. During the signal validation process, safety experts in our organization are required to review signals of disproportionate reporting (SDRs) and classify them into one of six predefined categories.
Objective: This experiment explored the extent to which predictive machine learning (ML) models can support the decision making of safety experts by accurately identifying the most appropriate predefined signal validation category.
Purpose: The aim of this study was to analyze the risk of hypersensitivity reactions (HSRs) to iopromide in children and elderly patients in comparison to adults.
Materials And Methods: Four observational studies were pooled and analyzed (analysis I). In addition, spontaneous reports from 1985 to 2020 from the pharmacovigilance database were evaluated (analysis II).
Background: The goal of the present cohort study was to review outcomes of patients exposed to interferon beta-1b during pregnancy.
Methods: Pregnancy cases with exposure to interferon beta-1b reported to Bayer's pharmacovigilance (PV) database from worldwide sources from January 1995 through February 2018 were retrieved for evaluation. Only cases where pregnancy outcomes were unknown at the time of reporting (i.