ascopubs.org

Lack of Concordance in Symptomatic Adverse Event Reporting by Children, Clinicians, and Caregivers: Implications for Cancer Clinical Trials

To examine concordance in symptomatic adverse event (AE) grading using the Common Terminology Criteria for Adverse Events (CTCAE 4.0) for clinicians and its patient-reported outcome (PRO) versions for ...
The New England Journal of Medicine

Evaluation of Acute Adverse Events after Covid-19 Vaccination during Pregnancy

Pregnant women with symptomatic coronavirus disease 2019 (Covid-19) have a higher risk of adverse outcomes than do women who are not pregnant. 1,2 In part because of these findings, Covid-19 ...
The Scientist

The FDA's New Adverse Event Dashboard: More Data Doesn't Mean a Better Understanding

On March 11, the FDA launched the Adverse Event Monitoring System (AEMS), consolidating several fragmented reporting databases into a single real-time public dashboard with artificial intelligence ...
RAPS

FDA consolidates adverse events reporting systems

The US Food and Drug Administration (FDA) announced it is unifying its various adverse reporting systems into a single system called the Adverse Event Monitoring System (AEMS). The agency said the ...