Multiple choice general knowledge

A patient in a clinical trial breaks his leg in a skiing accident - is it an SAE?

  1. No - it's not even an AE

  2. Yes - no question

  3. Yes if he stayed in hospital overnight or had serious complications

  4. Only if he withdrew from the study

  5. if he died after this accident
Reveal answer Fill a bubble to check yourself
C,E Correct answer
Explanation

An SAE (Serious Adverse Event) includes outcomes like death, life-threatening events, hospitalization, disability, or birth defects. A broken leg from skiing IS an AE, but only becomes an SAE if it requires hospitalization or results in death. Withdrawal doesn't determine SAE status.

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