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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

Antibiotics1999–2008a2009–2018dp value
Colistin
 FAERS (mean per year ± SD)8.1 ± 9.670.2 ± 51.40.00402
 AIFA (mean per year ± SD)0.4 ± 0.812.6 ± 9.30.0025
 Yellow Card Scheme (mean per year ± SD)1.7 ± 3.37.0 ± 3.00.0015
Gentamicin
 FAERS (mean per year ± SD)178 ± 70.5356.2 ± 176.30.0119
 AIFA (mean per year ± SD)6.1 ± 4.322.9 ± 6.7< 0.001
 Yellow Card Scheme (mean per year ± SD)11.5 ± 4.529.2 ± 16.20.00732
Meropenem
 FAERS (mean per year ± SD)96.5 ± 46.9504.8 ± 304.90.00214
 AIFA (mean per year ± SD)5.6 ± 2.945.5 ± 17.7< 0.001
 Yellow Card Scheme (mean per year ± SD)9.3 ± 4.335.2 ± 9.7< 0.001
Tigecyclin
 FAERSb (mean per year ± SD)101.3 ± 56.5147.4 ± 40.60.21
 AIFAc(mean per year ± SD)0.7 ± 1.213.3 ± 6.3< 0.001
 Yellow Card Schemec(mean per year ± SD)10 ± 5.36.3 ± 3.50.35
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