Table 4 Daptomycin-associated AEs in infants under 1 year old based on the ROR, PRR(χ2), EBGM(EBGM05), IC (IC025).

From: A pharmacovigilance study of daptomycin use in infants under 1 year old based on the FDA adverse event reporting system

PTs

a

ROR(95%Cl)

PRR(χ2)

EBGM(EBGM05)

IC (IC025)

Hepatic cytolysis

6

297.93 (123.75–717.22)

279.56 (1461.82)

1461.82 (700.87)

7.94 (6.20)

Drug reaction with eosinophilia

and systemic symptoms

3

92.54 (28.60–299.42)

89.71 (251.97)

251.97 (94.33)

6.42 (4.70)

Acute kidney injury

3

20.99 (6.61–66.64)

20.37 (54.80)

54.8 (20.84)

4.33 (2.64)

Hypotension

4

14.1 (5.17–38.49)

13.56 (46.36)

46.36 (20.01)

3.75 (2.06)

No adverse event

3

9.48 (3.00–30.01)

9.22 (21.95)

21.95 (8.37)

3.2 (1.50)

Product use in unapproved

indication

4

8.81 (3.23–24.02)

8.49 (26.45)

26.45 (11.43)

3.08 (1.39)

Respiratory failure

3

6.55 (2.07–20.70)

6.37 (13.62)

13.62 (5.20)

2.67 (0.97)

Product use issue

4

6 (2.20–16.34)

5.79 (15.92)

15.92 (6.88)

2.53 (0.84)

Off label use

6

2.86 (1.25–6.54)

2.74 (6.80)

6.8 (3.40)

1.46 (-0.24)

  1. Significant values are in [bold].
  2. a, the number of case reports.
  3. 95% CI, 95% confidence interval.
  4. ROR, reporting odds ratio.
  5. PRR, proportional reporting ratio; χ2, chi-squared.
  6. EBGM, empirical Bayesian geometric mean; EBGM05, the lower limit of the 95% CI of EBGM.
  7. IC, information component, calculated by Bayesian confidence propagation neutral network (BCPNN); IC025, the lower limit of the 95% CI of the IC.
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