What does the term 'Expectedness' refer to in the context of an ADR?

What does the term 'Expectedness' refer to in the context of an ADR?

• A. Whether the ADR is described in the product labeling or Investigator Brochure
• B. Whether the ADR is observed by more than one subject
• C. Whether the ADR is life-threatening
• D. Whether the ADR occurs after the trial ends

Answer: (A)

Expectedness in adverse drug reaction reporting means determining whether the reaction is already described in the drug’s reference safety information, specifically the labeling or the Investigator’s Brochure. If an ADR is listed there, it’s considered expected; if it isn’t, it’s unexpected. This distinction drives regulatory reporting obligations—unexpected, especially if serious, often triggers expedited reporting as a SUSAR, while expected events follow the standard safety reporting flow. It’s not about how many subjects are affected, whether the event is life‑threatening, or about when the trial ends. The key point is whether the ADR is described in the labeling or IB.

Expectedness in adverse drug reaction reporting means determining whether the reaction is already described in the drug’s reference safety information, specifically the labeling or the Investigator’s Brochure. If an ADR is listed there, it’s considered expected; if it isn’t, it’s unexpected. This distinction drives regulatory reporting obligations—unexpected, especially if serious, often triggers expedited reporting as a SUSAR, while expected events follow the standard safety reporting flow. It’s not about how many subjects are affected, whether the event is life‑threatening, or about when the trial ends. The key point is whether the ADR is described in the labeling or IB.