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Table 3 Overall ADR reports collected from FAERS, AIFA and Yellow Card Scheme Databases in 1999–2018

From: Relationship between adverse drug reactions to antibacterial agents and the Klebsiella pneumoniae carbapenemase-producing (KPC) Klebsiella pneumoniae outbreak: insight from a pharmacovigilance study

Antibiotics

1999–2008a

2009–2018d

p value

Colistin

 FAERS (mean per year ± SD)

8.1 ± 9.6

70.2 ± 51.4

0.00402

 AIFA (mean per year ± SD)

0.4 ± 0.8

12.6 ± 9.3

0.0025

 Yellow Card Scheme (mean per year ± SD)

1.7 ± 3.3

7.0 ± 3.0

0.0015

Gentamicin

 FAERS (mean per year ± SD)

178 ± 70.5

356.2 ± 176.3

0.0119

 AIFA (mean per year ± SD)

6.1 ± 4.3

22.9 ± 6.7

< 0.001

 Yellow Card Scheme (mean per year ± SD)

11.5 ± 4.5

29.2 ± 16.2

0.00732

Meropenem

 FAERS (mean per year ± SD)

96.5 ± 46.9

504.8 ± 304.9

0.00214

 AIFA (mean per year ± SD)

5.6 ± 2.9

45.5 ± 17.7

< 0.001

 Yellow Card Scheme (mean per year ± SD)

9.3 ± 4.3

35.2 ± 9.7

< 0.001

Tigecyclin

 FAERSb (mean per year ± SD)

101.3 ± 56.5

147.4 ± 40.6

0.21

 AIFAc(mean per year ± SD)

0.7 ± 1.2

13.3 ± 6.3

< 0.001

 Yellow Card Schemec(mean per year ± SD)

10 ± 5.3

6.3 ± 3.5

0.35

Ceftazidime-Avibactamd

 FAERS (mean per year ± SD)

–

53.3 ± 37.9

–

 AIFA (mean per year ± SD)

–

7.67 ± 4.5

–

 Yellow Card Scheme (mean per year ± SD)

–

7 ± 4.24

–

  1. SD Standard deviation
  2. a2002–2008 for AIFA Database
  3. b2005–2008 for Tigecycline
  4. c2006–2008 for Tigecycline
  5. d2016–2018 for Ceftazidime-Avibactam