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Table 1 Characteristics of pediatric patients admitted to ED for ADR

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

 

Tot ADRs N (% out of 834)

N involved patients

492

N ADRs/patients

 1

256 (52.03)

 2

155 (31.50)

 3+

81 (16.46)

Age

 Mean ± standard error, months

62.53 ± 2.09

Age classes

 New-borns (< 1 month)

7 (0.84)

 Infants (1–23 months)

332 (39.81)

 Children (24–143 months)

368 (44.12)

 Adolescents (144–192 months)

127 (15.23)

Sex

 Male

449 (53.48)

 Female

385 (46.16)

Ethnic group

 Caucasian

756 (90.65)

 Others

25 (3.00)

 Not available

53 (6.35)

Tot number of drugs

 1

448 (53.72)

 2

255 (30.58)

 3+

131 (15.71)

Seriousness

 Hospitalization

224 (26.86)

 Congenital abnormalities/ Deficit

1 (0.12)

 Other clinically relevant conditions

14 (1.68)

Outcome

 Complete resolution

48 (5.76)

 Improvement

483 (57.91)

 Invariant situation/worsening

18 (2.16)

 Not available

285 (34.17)

Drug-drug interactionsa

 No

308 (79.79)

 Yes

78 (20.21)

 Mild

4 (1.04)

 Moderate

17 (4.40)

 Severe

57 (14.77)

 

Tot drug ADR-pairs N (% out of 1100)

Drugs (vaccines excluded)

711 (64.64)

Causality

 In doubt

18

 Possible

301

 Probable

310

 Certain

82

Vaccines

389 (35.36)

Causality

 Not associable

6

 Undefined

50

 Associable

333

  1. aPercentage calculated on the total number of ADRs occurred in patients with more than one drug