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43. Reporting Odds Ratio (ROR)

43. Reporting Odds Ratio (ROR)

The Reporting Odds Ratio (ROR) the odds of a certain event occurring with your medicinal product, compared to the odds of the same event occurring with all other medicinal products in the database.

A signal is considered when the lower limit of the 95% confidence interval (CI) of the ROR is greater than one. The 95% confidence interval gives an indication of the precision of the estimate of the ROR.

For example, if the ROR is equal to three, the odds of reports of this event with your medicinal product are three times higher than the odds of reports of this event among all other reports in the database.

The ADR ROR is calculated and expressed as a point estimate with 95% confidence intervals (CI):

This reference risk is thought to reflect the baseline risk of the reporting of an event in a subject taking a drug, provided that there is no specific association between the drug and the event of interest. The question arises as to whether this reference risk always provides an accurate estimate of the baseline risk of an event for a patient receiving any drug, since it is obtained by considering a reference group of drugs that can include drugs known to be at risk for a particular event. 

The ROR may theoretically offer an advantage over PRR by estimating the relative risk. However, this apparent superiority has been called into question, because both disproportionality measures do not allow risk quantification, but only offer a rough indication of the strength of the signal  

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8 Comments

  1. Hi Ramya! Thak you for this great content! I have a question. When you say that the ROR takes to account “All the other medicinal products”, is it only from the same therapeutic class ou any other medicinal product? Thank you very much!

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