What is the number of Adverse Events (AEs), serious AEs, AEs leading to discontinuation, grouped by age? Do younger children tend to have more AE's than older children?
How similar is the safety profile in children compared to that previously observed in adults?
Are pediatric trials without a preceding trial in adults more likely to be stopped for safety concerns?
Answers to these questions could help accelerate pediatric drug development by balancing safety risks and speed.