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Table 1 Demographic data on overall adverse events with colistin, meropenem, tigecycline, gentamicin and ceftazidime/avibactam in FAERS, AIFA and Yellow Card Scheme Databases. In parenthesis, percentage of total is reported

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

 ColistinMeropenemTigecyclineGentamicinCeftazidime-Avibactam
FDAUKITFDAUKITFDAUKITFDAUKITFDAUKIT
ADR features
 Overall reports78387129601344549418799313553424072722131423
 Overall serious reports737 (94.1)81 (93.1)52 (40.3)5840 (97.1)377 (84.7)209 (42.3)1701 (90.5)85 (91.4)64 (47.4)4901 (91.7)367 (90.2)95 (34.9)180 (84.5)14 (100)17 (73.9)
 Overall Drug-SOC pairs256428422522,5571019761537321621919,4958234325103239
Age
 0–17 years82 (10.5)21 (24.2)6 (4.7)647 (10.7)59 (13.3)43 (8.7)51 (2.7)4 (4.3)2 (1.5)654 (12.3)41 (10.1)41 (15.1)9 (4.2)5 (35.7)0 (0)
 18–64 years396 (50.6)44 (50.6)62 (48.1)2596 (43.2)240 (53.9)192 (38.9)726 (38.6)45 (48.3)64 (47.4)2118 (39.6)191 (46.9)107 (39.3)79 (37.1)3 (21.4)8 (34.8)
  > 65 years165 (21.1)11 (12.6)41 (31.8)1964 (32.7)105 (23.6)254 (51.4)583 (31.1)22 (23.7)68 (50.4)1645 (30.8)140 (34.4)121 (44.5)45 (21.1)2 (14.3)6 (26.1)
 Unknown140 (17.8)11 (12.6)20 (15.4)806 (13.4)41 (9.2)5 (1)519 (27.6)22 (23.7)1 (0.7)925 (17.3)35 (8.6)3 (1.1)80 (37.6)4 (28.6)9 (39.1)
Sex
 Male369 (47.1)31 (35.6)62 (48.1)3014 (50.1)195 (43.8)247 (50)834 (44.4)44 (47.3)68 (50.4)2421 (45.3)199 (48.9)128 (47.1)88 (41.3)5 (35.7)14 (60.9)
 Female306 (39.1)50 (57.5)64 (49.6)2433 (40.5)217 (48.8)242 (49)732 (39)44 (47.3)66 (48.9)2353 (44.1)183 (45)142 (52.2)65 (30.5)8 (57.1)6 (26.1)
 Unknown108 (13.8)6 (6.9)3 (2.3)566 (9.4)33 (7.4)5 (1)313 (16.6)5 (5.4)1 (0.7)568 (10.6)25 (6.1)2 (0.7)60 (28.2)1 (7.2)3 (13)
  1. FDA FAERS Database, UK Yellow Card Scheme Database, IT AIFA Database