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Friday, January 6, 2017

# of FAERS Cases w/ non-serious outcomes has risen?

Okay. I think this is slightly more interesting than the previous post.


Here's some background on the FDA Adverse Event Reporting System (FAERS)

Every AERS/FAERS cases has the possibility of listing a serious outcome from an adverse event.

These outcomes fall into the following (non-mutually exclusive) categories:
  • congenital anomaly
  • death
  • disability
  • hospitalization
  • life-threatening
  • required intervention to prevent permanent impairment
  • other (serious outcome)
If you plot the number of serious outcomes reported per quarter versus the number of reports per quarter, they move almost in lock-step until around late 2010 or 2011 (compare red and blue lines below).

After late 2010, the # of serious outcomes begins to lag the # of reports, which indicates one of three things:

  1. The increase in the # of FAERS reports submitted over the past six years is mostly due to an increase in submission of reports w/ non-serious outcomes.
  2. The increase in the # of FAERS reports submitted over the past six year is mostly due to an increase in submission of reports w/ unknown outcomes.
  3. Some combination of points 1 and 2.




Data and code are here: https://github.com/pdanese/faers_counts_Q3_2016

Below is a slightly different way to view the same information.
The plot shows the ratio of serious patient outcomes to the number of reports filed per quarter. You can see that in the "early 2000s" the number of serious outcomes per report was around 1, but it has dropped in recent years 0.6 to 0.8 range. So, about 20 -- 40% of the FAERS reports since late 2012 do not report a serious outcome.