An Empirical Approach to Explore the Relationship Between Measures of Disproportionate Reporting and Relative Risks from Analytical Studies

Author:

Maciá-Martínez Miguel-Angel,de Abajo Francisco J.,Roberts Gilly,Slattery Jim,Thakrar Bharat,Wisniewski Antoni F. Z.

Funder

PROTECT Consortium

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,Toxicology

Reference30 articles.

1. Council for International Organizations of Medical Sciences (CIOMS). Practical Aspects of Signal Detection in Pharmacovigilance. Report of CIOMS Working Group VIII. Geneva 2010.

2. Evans SJW, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf. 2001;10(6):483–6.

3. European Medicines Agency, EudraVigilance Expert Working Group. Guideline on the use of statistical signal detection methods in the EudraVigilance data analysis system (EMEA/106464/2006 rev.1) [online]. Available from URL: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/11/WC500011434.pdf . Accessed 14 Jul 2015.

4. Hennessy S. Disproportionality analyses of spontaneous reports. Pharmacoepidemiol Drug Saf. 2004;13(8):503–4.

5. Rothman KJ, Lanes S, Sacks ST. The reporting odds ratio and its advantages over the proportional reporting ratio. Pharmacoepidemiol Drug Saf. 2004;13(8):519–23.

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