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OpenVigil FDA – Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications

Fig 2

OpenVigil FDA: 2x2 disproportionality analysis (DPA) output.

The letters “D”, “d”, “E” and “e” refer to the datasets involved. Chisq (), RRR, PRR, ROR are measurements of disproportionality (calculations see text). Cf. the OpenVigil tutorials and caveat document how to interpret this interesting signal suggesting that an antidepressant causes depression. The signal is probably due to a mixture of wrong reporting (e.g., the field for event was used instead of the field for indication in the reporting form), drug failure (events "depression" + "drug ineffective") and a certain vulnerable subpopulation. Access date 2016-03-15.

Fig 2

doi: https://doi.org/10.1371/journal.pone.0157753.g002