Publications by authors named "Aasia Bhatti"

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.

View Article and Find Full Text PDF
Article Synopsis
  • Gadobutrol, a gadolinium-based contrast agent introduced in 1998, has been administered over 100 million times, leading to extensive safety data collection.
  • A review of safety data from clinical studies and postmarketing surveillance revealed low rates of adverse events (AEs), with drug-related AEs reported in 3.4% of patients, and serious AEs in less than 0.1%.
  • The analysis found that adverse drug reactions (ADRs) were rare, with no significant increase in AEs in at-risk populations, including children and the elderly.
View Article and Find Full Text PDF

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.

View Article and Find Full Text PDF

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.

View Article and Find Full Text PDF

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.

View Article and Find Full Text PDF

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).

View Article and Find Full Text PDF

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.

View Article and Find Full Text PDF