A Comprehensive Approach to Selection of Adverse Drug Reactions for a Drug with Conditional Marketing Authorisation in the European Union

Key Points

• To explore the combination of statistical parameters and medical judgement in selecting adverse drug reactions for drug labels.
• Utilized a comprehensive approach assessing statistical parameters
• Incorporated medical judgement for safety risk classification
• Analyzed implications for product labeling
• Highlights the importance of integrating statistical and medical considerations
• Suggests a framework for improving drug safety evaluation
• Indicates potential changes in product labeling based on findings