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Table 4 Serious ADR reports collected in AIFA and Yellow Card Scheme Databases

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

Antibiotics1999–2008a2009–2018cp value
Colistin
 AIFA (mean per year ± SD)0.3 ± 0.55 ± 3.70.00291
 Yellow Card Scheme (mean per year ± SD)1.6 ± 3.36.5 ± 2.90.00264
Gentamicin
 AIFA (mean per year ± SD)2.3 ± 2.47.9 ± 5.00.015
 Yellow Card Scheme (mean per year ± SD)10.7 ± 4.626 ± 14.70.00977
Meropenem
 AIFA (mean per year ± SD)2 ± 1.719.5 ± 7.3< 0.0001
 Yellow Card Scheme (mean per year ± SD)7.9 ± 4.529.8 ± 8.5< 0.001
Tigecyclin
 AIFAb(mean per year ± SD)0.3 ± 0.66.3 ± 3.0< 0.001
 Yellow Card Schemeb(mean per year ± SD)9.3 ± 4.65.7 ± 3.40.30
Ceftazidime-Avibactamc
 AIFA (mean per year ± SD)5.7 ± 4.0
 Yellow Card Scheme (mean per year ± SD)4.7 ± 5.0
  1. SD Standard deviation
  2. a2002–2008 for AIFA Database
  3. b2006–2008 for Tigecycline
  4. c2016–2018 for Ceftazidime-Avibactam