Definition

A disproportionality measure that compares the odds of a specific event being reported for a drug versus the odds for all other drugs.

Example

ROR = (Drug X with Event A / Drug X without Event A) / (Other drugs with Event A / Other drugs without Event A). ROR > 1 suggests potential association.

Regulatory source

Pharmacoepidemiology Literature

Common mistakes

Confusing ROR with relative risk. ROR uses reporting odds, not true occurrence rates.

Inspector question

How do you interpret ROR values? What confidence intervals do you consider meaningful?

Related terms