Management of severe immune-related adverse events and outcomes in patients with advanced non-small cell lung cancer receiving immune checkpoint inhibitors.

Background: Immune checkpoint inhibitors (ICIs) are associated with severe immune-related adverse events (s-irAEs) that result in hospitalization, emergency department (ED) visits, treatment discontinuation, or death. This study examined the impact of s-irAEs and their earliest management strategies on clinical outcomes in advanced non-small cell lung cancer (NSCLC).

Methods: Data were derived from ConcertAI Patient360 NSCLC, a US-based electronic medical record database, between January 2012 and May 2021.

Understanding Hispanic/Latino Participation in Clinical Trials and Observational Studies, and Strategies to Increase Participation: A Targeted Literature Review.

Hispanic/Latino representation in medical research remains poor. We describe factors affecting rates of recruitment, participation, adherence, and retention of Hispanics/Latinos in clinical studies in the United States and characterize proposed strategies to improve these rates. A targeted literature review was conducted.

Adverse events and clinical outcomes in patients treated with PD-(L)1 blockade for advanced non-small-cell lung cancer.

To describe, in patients with advanced/metastatic non-small-cell lung cancer, the relationship between baseline immunosuppressive drug (ISD)/corticosteroid (CS) use, as well as the incidence of mild/moderate adverse events (AEs), and the clinical effectiveness of PD (L)-1 blockade. This was a retrospective cohort study of patients with no evidence (n = 131) or positive evidence (n = 269) of ISD/CS use. Duration of treatment, time to next treatment, progression-free survival and overall survival were significantly reduced for patients with evidence of prior ISD/CS use.

Individual Case Safety Report Replication: An Analysis of Case Reporting Transmission Networks.

Introduction: The basis of pharmacovigilance is provided by the exchange of Individual Case Safety Reports (ICSRs) between the recipient of the original report and other interested parties, which include Marketing Authorization Holders (MAHs) and Health Authorities (HAs). Different regulators have different reporting requirements for report transmission. This results in replication of each ICSR that will exist in multiple locations.

Predicting cardiac adverse events in patients receiving immune checkpoint inhibitors: a machine learning approach.

Background: Treatment with immune checkpoint inhibitors (ICIs) has been associated with an increased rate of cardiac events. There are limited data on the risk factors that predict cardiac events in patients treated with ICIs. Therefore, we created a machine learning (ML) model to predict cardiac events in this at-risk population.

Application of natural language processing techniques to identify off-label drug usage from various online health communities.

Objective: Outcomes mentioned on online health communities (OHCs) by patients can serve as a source of evidence for off-label drug usage evaluation, but identifying these outcomes manually is tedious work. We have built a natural language processing model to identify off-label usage of drugs mentioned in these patient posts.

Materials And Methods: Single patient posts from 4 major OHCs were considered for this study.

Investigating Overlap in Signals from EVDAS, FAERS, and VigiBase.

Introduction: The Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and VigiBase are two established databases for safety monitoring of medicinal products, recently complemented with the EudraVigilance Data Analysis System (EVDAS).

Objective: Signals of disproportionate reporting (SDRs) can characterize the reporting profile of a drug, accounting for the distribution of all drugs and all events in the database. This study aims to quantify the redundancy among the three databases when characterized by two disproportionality-based analyses (DPA).

Adverse events in patients with liver cancer.

This study aimed to further the understanding of the incidence of adverse events (AEs) in a population-based representative liver cancer population where there is currently a lack of knowledge. We carried out a retrospective cohort study using data from an administrative claims database between 1 January 2004 and 31 December 2010. Patients were included in the study if they had at least one primary liver cancer diagnosis [International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM): 155.

Selected adverse events in cancer patients treated with vascular endothelial growth factor inhibitors.

Introduction: To evaluate the safety profile of new drugs, it is important to quantify the rates of adverse events (AE). There has been little to no research on the safety of vascular endothelial growth factor (VEGF) inhibitors in population-based settings. The purpose of this study was to further the understanding of the incidence of AEs in a population-based representative cancer population receiving VEGF inhibitors where there currently is a deep lack of knowledge.