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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

 

Colistin

Meropenem

Tigecycline

Gentamicin

Ceftazidime-Avibactam

FDA

UK

IT

FDA

UK

IT

FDA

UK

IT

FDA

UK

IT

FDA

UK

IT

ADR features

 Overall reports

783

87

129

6013

445

494

1879

93

135

5342

407

272

213

14

23

 Overall serious reports

737 (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 pairs

2564

284

225

22,557

1019

761

5373

216

219

19,495

823

432

510

32

39

Age

 0–17 years

82 (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 years

396 (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 years

165 (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)

 Unknown

140 (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

 Male

369 (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)

 Female

306 (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)

 Unknown

108 (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