69  Immune-Related Adverse Events (irAEs)

69.1 What are irAEs?

Adverse events caused by immune activation (e.g., checkpoint inhibitors).

69.2 Common irAEs

  • Colitis
  • Pneumonitis
  • Hepatitis
  • Endocrinopathies

69.3 CRA Oversight

  • Long follow-up periods
  • Delayed onset
  • Steroid treatment documentation
  • Re-challenge decisions