Skip to main content

Table 4 Distribution of serious and non-serious drug-ADR pairs, and association between serious ADR risk and different factors, expressed as Reporting Odds Ratio (ROR)

From: Characterization of serious adverse drug reactions as cause of emergency department visit in children: a 5-years active pharmacovigilance study

 

Non-serious drug-ADR pairs

N (% out of 765)

Serious drug-ADRs pairs

N (% out of 335)

p-value

Adjusted ROR of serious ADR

[95% CI]

p-value

Age classes (FDA classification)

 Adolescents (144–192 months)

86 (11.24)

72 (21.49)

< 0.001

Ref

 

 Children (24–143 months)

335 (43.79)

123 (36.72)

 

0.41 [0.27–0.61]

< 0.001

 Infants (1–23 months)

336 (43.92)

137 (40.90)

 

0.47 [0.32–0.71]

0.001

 New-borns (< 1 month)

8 (1.05)

3 (0.90)

 

0.42 [0.10–1.70]

0.224

Sex

 Male

353 (46.14)

144 (42.99)

0.333

Ref.

 

 Female

412 (53.86)

191 (57.01)

 

0.77 [0.59–1.02]

0.072

Tot number of drugs

 1

347 (45.36)

101 (30.15)

< 0.001

Ref.

 

 2

276 (36.08)

128 (38.21)

 

1.87 [1.33–2.62]

< 0.001

 3+

142 (18.56)

106 (31.64)

 

3.01 [2.07–4.37]

< 0.001

Drug-drug interactions

 No

268 (64.11)

165 (70.51)

0.097

  

 Yes

150 (35.89)

69 (29.49)

 

0.77 [0.54–1.11]

0.166

Off-label vs on-label usea

 On-Label

447 (92.36)

201 (88.94)

0.133

Ref.

 

 Off-label

37 (7.64)

25 (11.06)

 

1.56 [0.90–2.73]

0.115

  1. Adjusted ROR values are shown along with the respective 95% Confidence Intervals
  2. aCalculated only on non-vaccine medications