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editorial
. 2014 Jul 2;37(8):557–567. doi: 10.1007/s40264-014-0189-0

Table 3.

Hypothetical output of the knowledge base when queried for evidence of an association between drug X and renal failure. Bold text indicates hypothetical hyperlinks that will take the expert directly to more detailed information

Drug ATC HOI Contra-indicated US SPL EU SmPC Scientific literature FDA FAERS VigiBase® EHR/Claims data
X Beta blocker Renal failure syndrome (disorder) False 1 Renal failure (1998) 1 Renal failure acute (2001)

13 publications (1998–)

Out of which:

3 case report (2001–)

2 RCTs (1998–)

8 observational studies (2003–)

0 systematic reviews

110 reports

PRR: 4.5

Renal failure

(April 1 2014)

148 reports

PRR: 3.3

Renal failure

(April 1 2014)

Associations:

Medicare

OR: 3.3

Medicaid

OR: 2.2

ATC Anatomical Therapeutic Chemical Classification System, EHR electronic health record, EU European Union, FAERS FDA Adverse Event Reporting System, FDA US Food and Drug Administration, HOI health outcome of interest, OR odds ratio, PRR proportional reporting ratio, RCT randomized controlled trial, SmPC Summary of Product Characteristics, SPL Structured Product Labeling